Locally Advanced and Metastatic Solid TumorsPhase 1NCT04047862
Study of Ociperlimab (BGB-A1217) in Combination With Tislelizumab in Advanced Solid Tumors
A Phase 1 study testing Ociperlimab, Tislelizumab and Pemetrexed in people with Locally Advanced and Metastatic Solid Tumors, run by BeiGene at 65 sites in 6 countries.
Trial summary
The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Locally Advanced and Metastatic Solid Tumors
- What is being tested?
- Ociperlimab, Tislelizumab and Pemetrexed
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 65 sitesin 6 countries
- Study dates
- 15 Aug 2019to 7 Aug 2024
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase 1 Key Inclusion Criteria
- Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 1.
- Greater than or equal to (>=) measurable lesion per RECIST v1.1.
- Had adequate organ function.
- Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
- Phase 1b Key Inclusion Criteria
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- Signed informed consent form (ICF) and able to comply with study requirements.
- Age >= 18 years (or the legal age of consent) at the time the ICF was signed.
- Histologically or cytologically confirmed tumor types in the following disease cohorts:
- Cohort 1: stage IV squamous NSCLC Cohort 2: stage IV non-squamous NSCLC Cohort 3: stage IV squamous or non-squamous NSCLC with PD-L1 positive. Cohort 4: extensive-stage SCLC Cohort 5: stage IIIB, IIIC or IV NSCLC Cohort 6: stage IV ESCC Cohort 7: stage IV EAC Cohort 8: recurrent or metastatic HNSCC incurable by local therapies Cohort 9: stage IV G/GEJ adenocarcinoma. Cohort 10: stage IV squamous or non-squamous NSCLC with PD-L1 positive.
- ECOG Performance Status <= 1
- Adequate organ function
- Were willing to use highly effective method of birth control
- Phase 1 Key Exclusion Criteria:
- Active brain or leptomeningeal metastasis.
- Active autoimmune diseases or history of autoimmune diseases that could have relapsed.
- Had severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for patients with hepatocellular carcinoma).
- Concurrent participation in another therapeutic clinical trial.
- Received prior therapies targeting TIGIT.
- Phase 1b Key Exclusion Criteria:
- Participants with any prior therapy for recurrent/metastatic disease.
- Non-squamous NSCLC patients with sensitizing epidermal growth factor receptor (EGFR) mutation, anaplastic lymphoma kinase (ALK) fusion, and c-ros oncogene 1 (ROS1) fusion.
- Gastric cancer participants with squamous or with positive HER2 expression.
- Prior therapy with any drug specifically targeting T-cell co-stimulation or checkpoint pathways. (anti-PD(L)1 exception for Cohort 5).
- Active leptomeningeal disease or uncontrolled brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse.
- With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, etc. (antiviral therapy is permitted for participants with hepatocellular carcinoma).
- Concurrent participation in another therapeutic clinical study.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Who cannot join
None listed.
Trial locations and contacts
65 sites in 6 countries.
65 sites in 6 countries
China23 sites
Beijing Tongren Hospital, Cmu
Beijing, Beijing Municipality, 100010
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Beijing Luhe Hospital, Capital Medical University
Beijing, Beijing Municipality, 101149
Jilin Cancer Hospital
Changchun, Jilin, 130021
Hunan Cancer Hospital
Changsha, Hunan, 410013
Sichuan Cancer Hospital and Institute
Chengdu, Sichuan, 610041
Chongqing Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Fujian Cancer Hospital
Fuzhou, Fujian, 350014
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510515
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
The Second Hospital of Anhui Medical University
Hefei, Anhui, 230601
Jinan Central Hospital
Jinan, Shandong, 250013
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200030
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Tianjin Medical University Cancer Institute and Hospital
Tianjin, Tianjin Municipality, 300060
Weifang Peoples Hospital
Weifang, Shandong, 261000
Union Hospital of Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022
Hubei Cancer Hospital
Wuhan, Hubei, 430079
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061
Henan Cancer Hospital
Zhengzhou, Henan, 450000
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Australia12 sites
Bendigo Health
Bendigo, Victoria, 3550
Pindara Private Hospital
Benowa, Queensland, 4217
Blacktown Cancer and Haematology Centre
Blacktown, New South Wales, 2148
Chris Obrien Lifehouse
Camperdown, New South Wales, 2050
Monash Health
Clayton, Victoria, 3168
St Vincents Hospital
Fitzroy, Victoria, 3065
Royal Hobart Hospital
Hobart, Tasmania, 7000
Linear Clinical Research
Nedlands, Western Australia, 6009
Icon Cancer Foundation
South Brisbane, Queensland, 4101
St John of God Health Care
Subiaco, Western Australia, 6008
Ashford Cancer Centre Research Northeast
Windsor Gardens, South Australia, 5087
Metro South Health, Cancer Trials Unit Division of Cancer Services Pah
Woolloongabba, Queensland, 4102
United States11 sites
Scri Florida Cancer Specialists South
Fort Myers, Florida, 33901
Mayo Clinic Jacksonville
Jacksonville, Florida, 32224
University of Kansas Medical Center Research Institute
Kansas City, Kansas, 66160
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Tennessee Oncology, Pllc Nashville
Nashville, Tennessee, 37203
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901
Mayo Clinic Phoenix
Phoenix, Arizona, 85254
Providence Portland Medical Center
Portland, Oregon, 97213
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Scri Florida Cancer Specialists North
St. Petersburg, Florida, 33705
Taiwan9 sites
Hualien Tzu Chi Hospital
Hualien City, 970
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301
Chung Shan Medical University Hospital
Taichung, 40201
China Medical University Hospital
Taichung, 40447
Veterans General Hospital Taichung
Taichung, 40705
National Taiwan University Hospital
Taipei, 10048
Taipei Veterans General Hospital
Taipei, 11217
Taipei Tzu Chi Hospital
Taipei, 231405
Linkou Chang Gung Memorial Hospital
Taoyuan, 33305
South Korea8 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi, 21565
Gyeongsang National University Hospital
Jinju, Gyeongsangnam-do, 52727
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 13620
Severance Hospital Yonsei University Health System
Seoul, Seoul Teugbyeolsi, 03722
The Catholic University of Korea, Seoul St Marys Hospital
Seoul, Seoul Teugbyeolsi, 06591
Smg Snu Boramae Medical Center
Seoul, Seoul Teugbyeolsi, 07061
The Catholic University of Korea, St Vincents Hospital
Suwon, Gyeonggi-do, 16247
New Zealand2 sites
Auckland City Hospital
Auckland, 1023
Nzcr Christchurch
Christchurch, 8011
About this study
Official title: Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1.
Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
- Being tested
- Ociperlimab, Tislelizumab, Pemetrexed, Paclitaxel, Nab paclitaxel
- Keywords
- BGB-A1217, Anti-TIGIT antibody, Tislelizumab, anti-PD-1 antibody, Ociperlimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OciperlimabDrug
Administered as an intravenous (IV) injection
TislelizumabDrug
Administered as an IV injection
PemetrexedDrug
Administered in accordance with local guidelines, prescribing information/summary of product
PaclitaxelDrug
Administered in accordance with local guidelines , prescribing information/summary of product
Nab paclitaxelDrug
Administered in accordance with local guidelines , prescribing information/summary of product
CarboplatinDrug
Administered in accordance with local guidelines , prescribing information/summary of product
CisplatinDrug
Administered in accordance with local guidelines , prescribing information/summary of product
EtoposideDrug
Administered in accordance with local guidelines , prescribing information/summary of product
5fluorouracilDrug
Administered in accordance with local guidelines , prescribing information/summary of product
OxaliplatinDrug
Administered in accordance with local guidelines , prescribing information/summary of product
CapecitabineDrug
Administered in accordance with local guidelines , prescribing information/summary of product
| Study group | Role | What they receive |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Experimental | Participants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, [i.e.], every 3 weeks [Q3W]) until disease progression, adverse events (AEs), participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Experimental | Participants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Experimental | Participants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Experimental | Participants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Experimental | Participants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Experimental | Participants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Experimental | Participants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Expansion: Cohort 1 | Experimental | Participants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin at an area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m^2 (Day 1) or nab paclitaxel 100 mg/m^2 (Days 1, 8 and 15) Q3W p until disease progression, intolerable toxicity, or withdrawal of consent. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Nab paclitaxel; Drug: Carboplatin |
| Phase 1b: Dose Expansion: Cohort 2 | Experimental | Participants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m^2 on Day 1 Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Pemetrexed; Drug: Carboplatin; Drug: Cisplatin |
| Phase 1b: Dose Expansion: Cohort 3 | Experimental | Participants with metastatic NSCLC (programmed cell death protein-ligand 1 [PD-L1] positive, tumor cell [TC] >=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Expansion: Cohort 4 | Experimental | Participants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m^2 (on Days 1, 2, 3), and cisplatin 75 mg/m^2 or carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Carboplatin; Drug: Cisplatin; Drug: Etoposide |
| Phase 1b: Dose Expansion: Cohort 5 | Experimental | Checkpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Expansion: Cohort 6 | Experimental | Participants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m^2 (Day 1), and 5-fluorouracil 750-800 mg/m^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5fluorouracil |
| Phase 1b: Dose Expansion: Cohort 7 | Experimental | Participants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m^2 (Day 1), and 5-Fluorouracil 750-800 mg/m^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Paclitaxel; Drug: Cisplatin; Drug: 5fluorouracil |
| Phase 1b: Dose Expansion: Cohort 8 | Experimental | Participants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score [vCPS] >= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Expansion: Cohort 9 | Experimental | Participants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m^2 [Day 1] and capecitabine 1000 mg/m^2 [Day 1-14 twice daily]), or (cisplatin 75 mg/m^2 [Day], and 5-FU 750-800 mg/m^2 [Day 1-5]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m^2 twice daily (Day 1-14) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab; Drug: Cisplatin; Drug: 5fluorouracil; Drug: Oxaliplatin; Drug: Capecitabine |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Experimental | articipants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Experimental | Participants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Experimental | Participants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. Receives: Drug: Ociperlimab; Drug: Tislelizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Measured: Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, >= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or <=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting > 7 days; >=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting > 7 days; >=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab.
Measured: Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)
Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab
MAD was defined as the highest dose of ociperlimab administered.
Measured: Up to 28 days (Dose escalation cohort)
Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab
RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.
Measured: up to 28 days (Dose escalation cohorts)
Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Secondary outcomes (21)
Phase 1: ORR as Per RECIST v.1.1
ORR was defined as the percentage of participants who had CR or PR as determined from investigator-derived tumor assessments per RECIST v. 1.1. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
Measured: Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)
Phase 1: Duration of Response (DOR) as Per RECIST v.1.1
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression (PD) or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1
DCR was defined as the percentage of participants with best overall response (BOR), as per RECIST v.1.1, of a CR, PR, or stable disease (SD). Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were measured. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".
Measured: C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Serum Concentrations of Tislelizumab was determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Measured: Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Serum concentration of ociperlimab was determined. Post-dose refers to the data collected for 30 minutes post-infusion. "C" in the timeframe below refers to "Cycle" and D refers to "Day" and "h" refers to "hours".
Measured: Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days)
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Measured: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days)
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted anti-drug antibodies (ADA) and neutralizing antibody (NAb) positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Measured: Up to 32.2 months (Dose escalation cohorts) and up to 11 months (Dose verification cohorts)
Phase 1b: DOR as Per RECIST v.1.1
DOR was defined as the time from the first determination of an overall response per RECIST v1.1 until the first documentation of progression or death, whichever came first. DOR was estimated using the Kaplan-Meier method. Per RECIST v.1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive disease was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b: DCR as Per RECIST v.1.1
DCR was defined as the percentage of participants with BOR, as per RECIST v.1.1, of a CR, PR, or SD. Per Response evaluation criteria in solid tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.
Measured: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1
PFS was defined as the time from the date of the first dose of study drugs to the date of the first documentation of PD assessed by the investigator using RECIST v1.1 or death, whichever occurred first. PFS was estimated using the Kaplan-Meier method. Per RECIST v1.1, PD was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study.
Measured: From first dose of study drugs to the date of the first documentation of PD or death, whichever came first (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. An SAE was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. TEAE was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to NCI-CTCAE v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Measured: Up to 30 days after the last dose of study interventions (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Measured: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Measured: Cycle 1 Day 1 (pre-dose and post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Serum concentrations of ociperlimab were determined. Post-dose refers to the data collected for 30 minutes post-infusion and 'h' in the time-frame section refers to hours.
Measured: Pre-dose, post-dose, 168 h, 336 h post-dose Cycle1 Day 1, Pre-dose on Cycle 2 Day 1, Pre-dose, post-dose (30 min) on Cycle 5 Day 1, Pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Serum concentrations of tislelizumab were determined. Post-dose refers to the data collected for 30 minutes post-infusion.
Measured: Cycle 1 Day 1 (pre-dose and post-dose, Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Immunogenic responses to ociperlimab and tislelizumab included: treatment emergent, treatment-induced and treatment boosted ADA and NAb positive assessments. Treatment-emergent ADA was defined as the sum of treatment-boosted ADA and treatment-induced ADA participants. Treatment-induced ADA was defined as ADA-evaluable participants that were ADA-negative at baseline and ADA-positive after drug administration during the treatment or follow-up observation period. Treatment-boosted ADA was defined as the Baseline-positive ADA-evaluable participants with significant increases (4-fold or higher) in ADA titer after drug administration during the treatment or follow-up observation period. NAb positive was defined as ADA-evaluable participants with positive Nab at any time including baseline and/or after drug administration.
Measured: Up to 34.4 months (Cohorts 1 to 9) and up to 20.8 months (Cohort 10)
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression.
The TIGIT expression on immune cells (IC) and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as <1% or >=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as <5% or >=5%.
ORR is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Measured: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression.
The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows:
For Cohort 1 and Cohort 2, PD-L1 TC <1% or >= 1%; for Cohorts 3, 5, and 10, PD-L1 TC < 50% or >=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) <1% or >=1%; for Cohort 9, PD-L1 TAP < 5% or >= 5%; for Cohort 6 and 8, PD-L1 TAP <10% or >=10%. ORR is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Measured: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression.
The TIGIT expression on immune cells and the classification thresholds were different for various cohorts. For Cohort 4, TIGIT IC was categorized as <1% or >=1%; for Cohorts 1, 2, 3, 5, 6, 8, 9 and 10, TIGIT IC was categorized as <5% or >=5%. Median PFS (mPFS) is reported for each TIGIT subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Measured: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
Archival or fresh tumor samples were collected for analysis of biomarkers for T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif (ITIM) domain (TIGIT) and PD-L1 expression. The PD-L1 expression scoring algorithm and the classification thresholds were also different for various cohorts as follows:
For Cohort 1 and Cohort 2, PD-L1 TC <1% or >= 1%; for Cohorts 3, 5, and 10, PD-L1 TC < 50% or >=50%; for Cohort 4, PD-L1 tumor area positivity (TAP) <1% or >=1%; for Cohort 9, PD-L1 TAP < 5% or >= 5%; for Cohort 6 and 8, PD-L1 TAP <10% or >=10%. mPFS is reported for each PD-L1 subgroup as relevant in each cohort. Biomarker data were not analyzed and reported for participants in Cohort 7.
Measured: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start15 Aug 2019
- Primary completion7 Aug 2024
- Study completion7 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Locally Advanced and Metastatic Solid TumorsStudies of the same condition, open and under way.
- More trials run by BeiGeneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- BeiGene
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeiGene
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04047862
- Sponsor's protocol ID
- BGB-900-105
- Other IDs
- AdvanTIG-105, CTR20202608
- Status last verified
- Aug 2025
- First submitted
- 1 Aug 2019
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
Publications
Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. J Immunother Cancer. 2023 Oct;11(10):e005829. doi: 10.1136/jitc-2022-005829.
PubMed 37857528
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/1b Study Investigating Safety, Tolerability, PK and Antitumor Activity of Anti-TIGIT Monoclonal Antibody BGB-A1217 in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT04047862
- Acronym / sponsor ID
- BGB-900-105
- Keywords
- BGB-A1217, Anti-TIGIT antibody, Tislelizumab, anti-PD-1 antibody, Ociperlimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- BeiGeneIndustry (pharma, biotech, devices)
- Study start
- 15 Aug 2019 (actual)
- Primary completion
- 7 Aug 2024 (actual)
- Study completion
- 7 Aug 2024 (actual)
- First posted
- 7 Aug 2019 (actual)
- Results
- Posted 22 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objectives of this study were: to assess the safety and tolerability, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and to determine the recommended Phase 2 dose (RP2D) of BGB-A1217 (known as ociperlimab) in combination with tislelizumab in participants with advanced solid tumors in phase 1.
Primary objective of Phase 1b was to assess overall response rate (ORR) determined by Investigator per Response Evaluation Criteria in Solid Tumors (RECIST) version (v).1.1 for patients in each dose-expansion cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 19
| Arm | Type | Receives |
|---|---|---|
| Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 50 milligrams (mg) intravenous (IV) infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (that is, [i.e.], every 3 weeks [Q3W]) until disease progression, adverse events (AEs), participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 150 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. |
| Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 450 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. |
| Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 900 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 1800 mg IV infusion on Day 1 of each cycle (cycle 1= 28 days) and tislelizumab 200 mg IV infusion on Day 8 of Cycle 1. If tolerated, participants received ociperlimab and tislelizumab doses IV on Cycle 2 Day 1 (cycle 2 onwards = 21 days) and thereafter every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. |
| Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg) | Experimental | Drug: OciperlimabParticipants received ociperlimab 900 mg as monotherapy IV infusion on Day 1 of each 21-day treatment cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg) | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants received ociperlimab 900 mg as IV infusion on Day 1 of each 21-day treatment cycle and tislelizumab 200 mg IV infusion once every 21 days (i.e. Q3W) until disease progression, intolerable toxicity, or withdrawal of consent. |
| Phase 1b: Dose Expansion: Cohort 1 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Paclitaxel, Drug: Nab paclitaxel, Drug: CarboplatinParticipants with metastatic squamous non-small cell lung cancer (NSCLC) received treatment with ociperlimab 900 mg IV infusion along with tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received 4 to 6 cycles of chemotherapy with carboplatin at an area under the curve (AUC) 5 or 6 (Day 1) + paclitaxel 200 or 175 mg/m^2 (Day 1) or nab paclitaxel 100 mg/m^2 (Days 1, 8 and 15) Q3W p until disease progression, intolerable toxicity, or withdrawal of consent. |
| Phase 1b: Dose Expansion: Cohort 2 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Pemetrexed, Drug: Carboplatin, Drug: CisplatinParticipants with metastatic non-squamous NSCLC received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle. Participants also received cisplatin 75 mg/m^2 or carboplatin (AUC 5) and pemetrexed 500 mg/m^2 (on Day 1) Q3W for 4-6 cycles followed by ociperlimab 900 mg + tislelizumab 200 mg + pemetrexed 500 mg/m^2 on Day 1 Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 3 | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants with metastatic NSCLC (programmed cell death protein-ligand 1 [PD-L1] positive, tumor cell [TC] >=1%) were treated with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 4 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Carboplatin, Drug: Cisplatin, Drug: EtoposideParticipants with extensive-stage small-cell lung cancer (SCLC) received treatment with ociperlimab 900 mg IV infusion, tislelizumab 200 mg IV infusion. Participants also received 4 cycles of etoposide 100 mg/m^2 (on Days 1, 2, 3), and cisplatin 75 mg/m^2 or carboplatin AUC 5 (Day 1) Q3W, followed by ociperlimab 900 mg (Day 1) + tislelizumab 200 mg (Day 1) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 5 | Experimental | Drug: Ociperlimab, Drug: TislelizumabCheckpoint inhibitor (CPI)-experienced NSCLC participants received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of each 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 6 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Drug: 5fluorouracilParticipants with metastatic esophageal squamous cell carcinoma (ESCC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m^2 (Day 1), and 5-fluorouracil 750-800 mg/m^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 7 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Paclitaxel, Drug: Cisplatin, Drug: 5fluorouracilParticipants with metastatic esophageal adenocarcinoma (EAC) received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, cisplatin 75 mg/m^2 (Day 1), and 5-Fluorouracil 750-800 mg/m^2 (5-FU; Day 1 to Day 5) or paclitaxel 200 or 175 mg/m^2 (Day 1) Q3W followed by ociperlimab 900 mg and tislelizumab 200 mg on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 8 | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC; PD-L1 positive, visually estimated Combined Positive Score [vCPS] >= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusions on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Expansion: Cohort 9 | Experimental | Drug: Ociperlimab, Drug: Tislelizumab, Drug: Cisplatin, Drug: 5fluorouracil, Drug: Oxaliplatin, Drug: CapecitabineParticipants with unresectable, locally advanced, recurrent, or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma received treatment with 6 cycles of ociperlimab 900 mg (Day 1) IV infusion, tislelizumab 200 mg (Day 1) IV infusion, (oxaliplatin 1300 mg/m^2 [Day 1] and capecitabine 1000 mg/m^2 [Day 1-14 twice daily]), or (cisplatin 75 mg/m^2 [Day], and 5-FU 750-800 mg/m^2 [Day 1-5]) Q3W followed by ociperlimab 900 mg (Day 1), tislelizumab 200 mg (Day 1) + capecitabine 1000 mg/m^2 twice daily (Day 1-14) Q3W until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg) | Experimental | Drug: Ociperlimab, Drug: Tislelizumabarticipants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 450 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 900 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
| Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg) | Experimental | Drug: Ociperlimab, Drug: TislelizumabParticipants with metastatic NSCLC (PD-L1 positive, TC >= 1%) received treatment with ociperlimab 1800 mg IV infusion and tislelizumab 200 mg IV infusion on Day 1 of every 21-day cycle until disease progression, AEs, participant withdrew consent, lost to follow-up or death, whichever came first. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Phase 1 Key Inclusion Criteria
- Had Eastern Cooperative Oncology Group (ECOG) Performance Status less than or equal to (<=) 1.
- Greater than or equal to (>=) measurable lesion per RECIST v1.1.
- Had adequate organ function.
- Phase 1- Participants with histologically or cytologically confirmed advanced, metastatic, unresectable solid tumors who had previously received standard systemic therapy or for which treatment is not available, not tolerated or refused.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OciperlimabAdministered as an intravenous (IV) injection | Drug | Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg, Phase 1: Dose Verification: Cohort 1A (Ociperlimab 900 mg), Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg), Phase 1b: Dose Expansion: Cohort 1, Phase 1b: Dose Expansion: Cohort 2, Phase 1b: Dose Expansion: Cohort 3, Phase 1b: Dose Expansion: Cohort 4, Phase 1b: Dose Expansion: Cohort 5, Phase 1b: Dose Expansion: Cohort 6, Phase 1b: Dose Expansion: Cohort 7, Phase 1b: Dose Expansion: Cohort 8, Phase 1b: Dose Expansion: Cohort 9, Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg), Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg), Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) |
| TislelizumabAdministered as an IV injection | Drug | Phase 1: Dose Escalation: Ociperlimab 150 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 1800 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 450 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 50 mg + Tislelizumab 200 mg, Phase 1: Dose Escalation: Ociperlimab 900 mg + Tislelizumab 200 mg, Phase 1: Dose Verification: Cohort 1B (Ociperlimab 900 mg + Tislelizumab 200 mg), Phase 1b: Dose Expansion: Cohort 1, Phase 1b: Dose Expansion: Cohort 2, Phase 1b: Dose Expansion: Cohort 3, Phase 1b: Dose Expansion: Cohort 4, Phase 1b: Dose Expansion: Cohort 5, Phase 1b: Dose Expansion: Cohort 6, Phase 1b: Dose Expansion: Cohort 7, Phase 1b: Dose Expansion: Cohort 8, Phase 1b: Dose Expansion: Cohort 9, Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 1800 mg + Tislelizumab 200 mg), Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 450 mg + Tislelizumab 200 mg), Phase 1b: Dose Optimization: Cohort 10: (Ociperlimab 900 mg + Tislelizumab 200 mg) |
| PemetrexedAdministered in accordance with local guidelines, prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 2 |
| PaclitaxelAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 1, Phase 1b: Dose Expansion: Cohort 6, Phase 1b: Dose Expansion: Cohort 7 |
| Nab paclitaxelAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 1 |
| CarboplatinAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 1, Phase 1b: Dose Expansion: Cohort 2, Phase 1b: Dose Expansion: Cohort 4 |
| CisplatinAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 2, Phase 1b: Dose Expansion: Cohort 4, Phase 1b: Dose Expansion: Cohort 6, Phase 1b: Dose Expansion: Cohort 7, Phase 1b: Dose Expansion: Cohort 9 |
| EtoposideAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 4 |
| 5fluorouracilAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 6, Phase 1b: Dose Expansion: Cohort 7, Phase 1b: Dose Expansion: Cohort 9 |
| OxaliplatinAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 9 |
| CapecitabineAdministered in accordance with local guidelines , prescribing information/summary of product | Drug | Phase 1b: Dose Expansion: Cohort 9 |
Primary outcome
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Time frame: Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
An AE was defined as any unfavorable and unintended sign, symptom, or disease associated with the use of study drugs, whether considered related to study drugs or not. A serious adverse event (SAE) was any untoward medical occurrence that, at any dose, resulted in death, was life-threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability, was a congenital anomaly or was considered a medically significant. Treatment-emergent adverse event (TEAE) was an AE that has an onset date or a worsening in severity from baseline on or after the first dose of study drug up to 30 days following study drug discontinuation or initiation of the first new systemic anticancer therapy, whichever occurred first. Severity of AEs was assessed according to National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) v.5.0, which consists of: Grade 1 Mild; Grade 2 Moderate; Grade 3: Severe; Grade 4: Life-threatening; Grade 5: Death due to AE.
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days (for Dose escalation cohorts) and up to 21 days (for Dose verification cohorts)
The DLTs were defined as high grade (Grade 3 or 4) non-hematologic toxicities (that is, >= Grade 4 toxicity; Grade 3 toxicity that is clinically significant and does not resolve to baseline or <=Grade 1 within 7 days of initiating optimal supportive care), or hematologic toxicities (Grade 4 neutropenia lasting > 7 days; >=Grade 3 febrile neutropenia; Grade 3 thrombocytopenia with clinically significant bleeding; Grade 4 thrombocytopenia lasting > 7 days; >=Grade 4 anemia occurring during the DLT assessment window and considered by the investigator to be related to ociperlimab and/or tislelizumab.
Phase 1: Maximum Administered Dose (MAD) of Ociperlimab in Combination With Tislelizumab
Time frame: Up to 28 days (Dose escalation cohort)
MAD was defined as the highest dose of ociperlimab administered.
Phase 1: Recommended Phase 2 Dose (RP2D) of Ociperlimab in Combination With Tislelizumab
Time frame: up to 28 days (Dose escalation cohorts)
RP2D of Ociperlimab in combination with Tislelizumab 200 mg was determined primarily from the safety, tolerability, and pharmacokinetic (PK) data of dose escalation cohorts.
Phase 1b: Overall Response Rate (ORR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
ORR was defined as the percentage of participants who had complete response (CR) or partial response (PR). Per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1., CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
21 secondary outcomes
Phase 1: ORR as Per RECIST v.1.1
Time frame: Maximum time duration on study: up to 35.7 months (Dose escalation cohorts) and up to 13.3 months (Dose verification cohorts)
Phase 1: Duration of Response (DOR) as Per RECIST v.1.1
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Phase 1: Disease Control Rate (DCR) as Per RECIST v.1.1
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])
Phase 1 (Dose Escalation): Serum Concentrations of Ociperlimab
Time frame: C1D1 (pre and post dose; 24 hours (h) 72h, 168h and 336 h post-dose), C2D1 (pre- and post-dose), C5D1 (pre and post dose,168h and 336 h post-dose), C6D1 (pre and post-dose), pre-dose on C9D1,C13D1,C17D1,C25D1 (Cycle 1= 28 days; Cycle 2 onwards= 21 days)
Phase 1 (Dose Escalation): Serum Concentrations of Tislelizumab
Time frame: Cycle 1, Day 8 (pre-dose), Cycle 1, Day 8 (post-dose), Cycle 2, Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 25 Day 1 (each cycle = 21 days)
Phase 1 (Dose Verification): Serum Concentrations of Ociperlimab
Time frame: Pre-dose, post-dose, 24 h,72 h,168 h,336 h post-dose C1D1, Pre-dose, post-dose on C2D1, Pre-dose, post-dose,168 h, 336 h post-dose on C5D1, Pre-dose, post-dose on C6D1, pre-dose C9D1 and C13D1 (each cycle = 21 days)
Phase 1 (Dose Verification): Serum Concentrations of Tislelizumab
Time frame: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose), Cycle 5 Day 1 (post-dose), Cycle 6 Day 1 (pre-dose), Cycle 9 Day 1 (pre-dose), Cycle 13 Day 1 (pre-dose) (each cycle = 21 days)
Phase 1: Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Time frame: Up to 32.2 months (Dose escalation cohorts) and up to 11 months (Dose verification cohorts)
Phase 1b: DOR as Per RECIST v.1.1
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b: DCR as Per RECIST v.1.1
Time frame: From the first determination of an overall response until PD or death, whichever came first (Maximum time duration on study: Up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b: Progression Free Survival (PFS) as Per RECIST v.1.1
Time frame: From first dose of study drugs to the date of the first documentation of PD or death, whichever came first (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b (Cohorts 1-10): Number of Participants With TEAEs and TESAEs
Time frame: Up to 30 days after the last dose of study interventions (Maximum time duration on study: up to 41.6 months [Cohorts 1 to 9] and up to 21.4 months [Cohort 10])
Phase 1b (Cohort 1-9): Serum Concentrations of Ociperlimab
Time frame: Cycle 1 Day 1 (pre-dose), Cycle 1 Day 1 (post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 1-9): Serum Concentrations of Tislelizumab
Time frame: Cycle 1 Day 1 (pre-dose and post-dose), Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 10): Serum Concentrations of Ociperlimab
Time frame: Pre-dose, post-dose, 168 h, 336 h post-dose Cycle1 Day 1, Pre-dose on Cycle 2 Day 1, Pre-dose, post-dose (30 min) on Cycle 5 Day 1, Pre-dose on Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 10): Serum Concentrations of Tislelizumab
Time frame: Cycle 1 Day 1 (pre-dose and post-dose, Cycle 2 Day 1 (pre-dose), Cycle 5 Day 1 (pre-dose and post-dose), pre-dose of Cycle 6 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1 and Cycle 25 Day 1 (each cycle = 21 days)
Phase 1b (Cohort 1-10): Number of Participants With Immunogenic Response to Ociperlimab and Tislelizumab
Time frame: Up to 34.4 months (Cohorts 1 to 9) and up to 20.8 months (Cohort 10)
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: TIGIT Biomarkers Expression
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): Percentage of Participants With ORR: PD-L1 Biomarkers Expression
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): PFS in TIGIT Biomarkers Expression
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Phase 1b (Cohort 1-10): PFS in PD-L1 Biomarkers Expression
Time frame: Maximum time duration on study: up to 41.6 months (Cohorts 1 to 9) and up to 21.4 months (Cohort 10)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37857528Frentzas S, Kao S, Gao R, Zheng H, Rizwan A, Budha N, de la Hoz Pedroza L, Tan W, Meniawy T. AdvanTIG-105: a phase I dose escalation study of the anti-TIGIT monoclonal antibody ociperlimab in combination with tislelizumab in patients with advanced solid tumors. J Immunother Cancer. 2023 Oct;11(10):e005829. doi: 10.1136/jitc-2022-005829.
- Individual participant dataSharing planned: Yes. BeiGene shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved. BeiGene shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations. Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeiGene review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
BeiGene
65 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Ociperlimab, Tislelizumab and Pemetrexed in people with Locally Advanced and Metastatic Solid Tumors, run by BeiGene at 65 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in China, Australia, United States, Taiwan, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase 1: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) (time frame: Up to 30 days after the last dose of study interventions (up to 35.7 months [Dose escalation cohorts] and up to 13.3 months [Dose verification cohorts])). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04047862, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.