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Solid TumorsPhase 1NCT02660034

The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Participants With Advanced Solid Tumors

A Phase 1 study testing Tislelizumab and Pamiparib in people with Solid Tumors, run by BeiGene at 29 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor BGB-290 (pamiparib) in participants with advanced solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumors
What is being tested?
Tislelizumab and Pamiparib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
229 participants
Where
29 sitesin 6 countries
Study dates
2 Feb 2016to 9 Sep 2020
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

  • Participants voluntarily agreed to participate by giving written informed consent.
  • Must have received standard of care in the primary treatment of their disease.
  • Participants who had the below specified histologically confirmed malignancies that had progressed to the advanced or metastatic stage:
  • In Part A, the participants must have had an advanced malignancy, including but not limited to high-grade serous cancer of the ovary, fallopian tube, or peritoneum, triple negative breast cancer, small cell lung cancer (SCLC), primary peritoneal cancer, and any tumor likely to harbor DNA damage repair deficiencies susceptible to treatment with a PARP inhibitor or likely to be responsive to a PD-1 blocker.
  • In Part B, the participants recruited to 1 of the 8 expansion arms must have had advanced solid tumors of the following types:
  • Arm 1: Participants with relapsed, platinum-sensitive high-grade epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer (EOC) must have met the following criteria:
Show all 50Show fewer
  • Must have had at least 2 prior platinum-containing treatments in any treatment setting.
  • Must have had platinum-sensitive recurrent disease and must not have progressed (by Response Evaluation Criteria in Solid Tumors [RECIST] v1.1 criteria) within 6 months of the completion of the last platinum-containing line of treatment.
  • Note: Participants may have received additional non-platinum-based chemotherapy for recurrence after prior last platinum-containing regimen if the criteria for platinum sensitivity were met.
  • Arm 1a: Participants with relapsed, platinum-sensitive high-grade EOC with either known deleterious or suspected deleterious germline or somatic breast cancer susceptibility gene 1/2 (BRCA1/2) mutations or with homologous recombination deficiency (HRD).
  • If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was BRCA1/2 or HRD positive, the participant was eligible for enrollment in Arm 1a.
  • Arm 1b: Participants with relapsed, platinum-sensitive high grade EOC who otherwise met the above criteria and were without known germline or somatic BRCA1/2 mutations and without HRD mutation.
  • Arm 2: Participants with triple negative breast cancer must have met the following criteria:
  • 0-1 prior platinum-containing treatment in any treatment setting.
  • Note: participants could have received additional therapy after the last platinum-containing line of treatment if the other eligibility criteria were met.
  • Participants who received at least 1 prior treatment but not more than 3 prior lines of treatment in the advanced or metastatic setting.
  • Known deleterious or suspected deleterious germline or somatic BRCA1/2 mutations or with documented HRD.
  • If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was HRD positive, then the participant was eligible for enrollment in Arm 2.
  • If archival tissue was not available and the participant submitted a fresh tumor biopsy, then the diagnostic test needed to demonstrate somatic BRCA1/2 mutation or HRD positivity.
  • Arm 3: Participants with metastatic castration-resistant prostate cancer, including but not limited to mutations in homologous recombination (HR) pathways and/or defined by HRD algorithms, and must have met the following criteria:
  • May be either chemotherapy-naïve, but must have received prior abiraterone acetate and/or enzalutamide treatment, or have previously had no more than 2 taxane-based chemotherapy lines of treatment, including docetaxel and carbazitaxel. If docetaxel was used more than once, this was considered as 1 line of treatment.
  • At least 2 weeks since the completion of prior flutamide, bicalutamide, and nilutimide, or enzalutamide and abiraterone treatment.
  • Documented prostate cancer with one of the following:
  • Surgically or medically castrated. The testosterone levels did not need to be checked if the participant had undergone surgical castration for > 4 months. Participants receiving chemical castration should have had testosterone levels checked at baseline and confirmed to be in the castrate levels (< 0.5 ng/mL or 1.735 nM). In all cases, the luteinizing hormone-releasing hormone antagonist/agonist was to be continued in these participants.
  • Participants with only non-measurable bone lesions must have had disease progression based on Prostate Cancer Clinical Trials Working Group with 2 or more new lesions or have had prostate-specific antigen progression before enrolment.
  • Known deleterious or suspected deleterious germline or somatic BRCA1/2 mutations or with documented HRD.
  • If HRD or BRCA1/2 mutation status from archival tissue was unknown or had not been previously evaluated, then the archival tissue must have undergone tissue screening using a validated diagnostic test to determine eligibility. If the diagnostic test result was HRD positive, then the participant was be eligible for enrollment in Arm 3.
  • If archival tissue was not available and the participant summitted a fresh tumor biopsy, then the diagnostic test needed to demonstrate somatic BRCA1/2 mutation or HRD positivity.
  • Arm 4: Participants with extensive-stage disease SCLC must have met the following criteria:
  • Received at least 1 and not more than 2 prior lines of treatment; ii. At least 1 prior line of treatment must have contained a platinum agent
  • Arm 5: Participants with human epidermal growth factor receptor-2 (HER2)-negative gastric or gastroesophageal junction cancer must have met the following criteria:
  • May have received at least 1 and not more than 2 prior lines of treatment
  • Arm 6: Participants with locally advanced or metastatic urothelial (muscle-invasive bladder, ureter, urethra, or renal pelvis) cancer must have met the following criteria:
  • Received at least 1 and not more than 2 prior lines of treatment in the advanced or metastatic disease setting; ii. At least 1 prior line of treatment must have contained a platinum agent
  • Arm 7: Participants with advanced or metastatic pancreatic adenocarcinoma must have met the following criteria:
  • Received at least 1 but not more than 2 lines of treatment in either an advanced or metastatic setting; ii. At least 1 prior treatment for advanced or metastatic disease must have contained a platinum agent; iii. Participants with known deleterious germline or somatic BRCA1/2 mutation could be considered for the study even if platinum naïve.
  • Arm 8: (Note: Closed to enrollment) Participants with advanced or metastatic recurrent non-ovarian gynecological cancers (endometrial cancer, cancer of the cervix and participants with tumors known to be mismatch repair deficient or HRD positive) must have met the following criteria:
  • Participants with a complete response, partial response, or stable disease from at least 1 prior platinum-containing treatment in any treatment setting; ii. The Sponsor medical monitor would approve tumor types for Arm 8 prior to screening.
  • Note: Excluded tumor types included participants with bone or soft tissue sarcoma; central nervous system (CNS) malignancies; colorectal cancer (except microsatellite instability-high colorectal cancer is permitted); cutaneous or ocular melanoma; hematologic malignancies; HER2-negative breast cancer without BRCA mutation; mesothelioma, papillary, follicular, medullary or Hürthle cell thyroid cancer; unknown primary malignancy.
  • Participants who were treated with chemotherapy or any investigational therapies, if eligible, must have completed at least 4 weeks or at least 5 half-lives (whichever is longer, but no less than 3 weeks) before the study drug administration, and all adverse events (AEs) had either returned to baseline or stabilized.
  • At least 2 weeks from palliative radiotherapy.
  • Participants must have had archival tumor tissue or agree to a tumor biopsy for mutation and biomarkers analysis unless previously discussed with Sponsor's medical monitor or its designee (fresh tumor biopsies were recommended at baseline in participants with readily accessible tumor lesions and who consented to the biopsies). Participants with ovarian, fallopian tube, primary peritoneal, or breast cancer in Part A and all participants enrolled in Part B must also have agreed to provide fresh blood sample at the baseline for the evaluation of BRCA mutations and/or confirmation of prior BRCA results or other HR deficiency mutations, even if it was previously tested.
  • Participants must have had measurable disease as defined in RECIST v1.1. Participants with metastatic castration-resistant prostate cancer and epithelial, non-mucinous, ovarian cancer, fallopian tube, or primary peritoneal cancer may have used separate disease-specific criteria.
  • Male or female ≥ 18 years of age on the day of signing informed consent.
  • Must have had an Eastern Cooperative Oncology Group Performance Status ≤ 1.
  • Must have had a life expectancy ≥ 12 weeks.
  • Must have had adequate organ function.
  • Females of childbearing potential must have been willing to use a highly effective method of birth control for the duration of the study, and for at least 6 months after the last dose of investigational drug, and have had a negative serum pregnancy test within 7 days of the first dose of study drug(s).
  • Non-sterile males and their female partners must have been willing to use a highly effective method of birth control for the duration of the study and for at least 6 months after the last dose of investigational drug. Nonsterile males must have avoided sperm donation for the duration of the study and for at least 6 months after last study drug.
  • Females must have agreed not to breastfeed starting at screening and throughout the study period, and for 6 months after the final study drug administration.

Who cannot join

  • Participants with ovarian cancer who have platinum-resistant/refractory disease, defined as progressive disease at the first tumor assessment while receiving platinum-containing chemotherapy.
  • Participant had history of severe hypersensitivity reactions to other mAbs.
  • Any major surgery within 28 days before first dose of study drugs.
  • Prior allogeneic stem cell transplantation or organ transplantation.
  • Participants with toxicities (as a result of prior anticancer therapy) that had not recovered to baseline or stabilized, except for AEs not considered a likely safety risk (for example, alopecia, neuropathy and specific laboratory abnormalities).
  • Concurrent participation in another clinical trial.
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  • Prior malignancy within the previous 2 years except for locally curable non-melanoma dermatologic cancers that had been apparently cured, such as basal or squamous cell skin cancer, or carcinoma in situ of the skin, cervix, breast, bladder, or prostate.
  • Symptomatic CNS metastasis or leptomeningeal disease. Note: Baseline magnetic resonance imaging of the brain and spinal cord was required for SCLC participants enrolled in Arm 4 if they had a history of CNS disease.
  • Note: Participants with previously treated CNS metastatic disease were eligible for any arm if CNS metastatic disease was asymptomatic, clinically stable, and did not require corticosteroids or anticonvulsants within a minimum of 4 weeks of enrollment.
  • Prior therapies targeting PD-1, programmed death-ligand 1 (PD-L1), or PARP.
  • Active autoimmune diseases or history of autoimmune diseases that may have relapsed.
  • Note: Participants with the following diseases were not excluded and may have proceeded to further screening:
  • Controlled Type I diabetes;
  • Hypothyroidism managed with no treatment other than with hormone replacement therapy;
  • Controlled celiac disease;
  • Skin diseases not requiring systemic treatment (for example, vitiligo, psoriasis, alopecia);
  • Any other disease that was not expected to recur in the absence of external triggering factors.
  • Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication within 2 weeks of the study drug administration.
  • Note: Participants who were currently or had previously been on any of the following steroid regimens were not excluded:
  • Adrenal replacement steroid (dose ≤ 10 mg daily of prednisone or equivalent);
  • Topical, ocular, intra-articular, intranasal, or inhalational corticosteroid with minimal systemic absorption;
  • Short course (≤ 7 days) of corticosteroid prescribed prophylactically (for example, for contrast dye allergy) or for the treatment of a non-autoimmune condition (for example, delayed-type hypersensitivity reaction caused by contact allergen).
  • With severe chronic or active infections requiring systemic antibacterial, antifungal or antiviral therapy, including tuberculosis infection, et cetera.
  • History of interstitial lung disease, non-infectious pneumonitis or uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung diseases, et cetera.
  • History of non-viral hepatitis or cirrhosis.
  • Positive human immunodeficiency virus status.
  • A known history of hepatitis B virus or hepatitis C virus infection.
  • History of alcohol abuse.
  • Underlying medical conditions or alcohol or drug abuse or dependence that, in the investigator's opinion, would be unfavorable for the administration of study drug or affect the explanation of drug toxicity or AEs; or insufficient compliance during the study according to investigator's judgement.
  • Inability to swallow oral medications (capsules and tablets) without chewing, breaking, crushing, opening, or otherwise altering the product formulation. Participants should not have had gastrointestinal illnesses that would have precluded the absorption of pamiparib, which was an oral agent.
  • Had been administered a live vaccine within 4 weeks (28 days) of initiation of study therapy.
  • Any of the following cardiovascular criteria:
  • Current evidence of cardiac ischemia;
  • Current symptomatic pulmonary embolism;
  • Acute myocardial infarction ≤ 6 months prior to Day 1;
  • Heart failure of New York Heart Association Classification III or IV ≤ 6 months prior to Day 1;
  • Grade ≥ 2 ventricular arrhythmia ≤ 6 months prior to Day 1;
  • History of cerebrovascular accident within 6 months before first dose of study drugs.
  • Use or had anticipated need for food or drugs known to be strong or moderate cytochrome P450 (CYP)3A inhibitors or strong CYP3A inducers ≤ 10 days (or ≤ 5 half-lives, whichever is shorter) prior to Day 1.
  • Note: Other protocol-defined Inclusion/Exclusion criteria may have applied.

Trial locations and contacts

29 sites in 6 countries.

29 sites in 6 countries

United States12 sites

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Roswell Park Cancer Institute

    Buffalo, New York, 14263

  • Texas Oncology

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Virginia Cancer Specialists

    Fairfax, Virginia, 22031

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Pinnacle Oncology Hematology

    Scottsdale, Arizona, 85258

  • Texas Oncology

    Tyler, Texas, 75702

Other trials in United States

Australia10 sites

  • Icon Cancer Care

    Brisbane, Queensland, 4101

  • Monash Health

    Clayton, Victoria

  • Mid North Coast Cancer Institute

    Coffs Harbour, New South Wales, 2450

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria

  • Linear Clinical Research Ltd

    Nedlands, Western Australia

  • Calvary Mater Newcastle

    Newcastle, New South Wales, 2298

  • Westmead Hospital

    Parramatta, New South Wales

  • Prince of Wales

    Randwick, New South Wales

  • Northern Cancer Institute

    St Leonards, New South Wales, 2065

Other trials in Australia

France2 sites

  • Institut Gustave Roussy

    Paris, 94800

  • Centre Eugene Marquis

    Rennes, 35042

Other trials in France

New Zealand2 sites

  • Auckland City Hospital

    Auckland, 1023

  • Capital and Coast District Health Board

    Wellington, 6021

Other trials in New Zealand

Spain2 sites

  • Hospital Universitario Vall d'Hebrón

    Barcelona, 08035

  • Hospital Clínico Universitario de Valencia

    Valencia, 46010

Other trials in Spain

United Kingdom1 site

  • Sarah Cannon Research Institute

    London, W1G 6AD

Other trials in United Kingdom

About this study

Official title: A Phase 1/1b, Open Label, Multiple Dose, Dose Escalation and Expansion Study to Investigate the Safety, Pharmacokinetics and Antitumor Activity of the Anti-PD-1 Monoclonal Antibody BGB-A317 in Combination With the PARP Inhibitor BGB-290 in Subjects With Advanced Solid Tumors

This trial studied the safety, pharmacokinetics, and antitumor activity of the anti-programmed cell death 1 (PD-1) monoclonal antibody (mAb) BGB-A317 (tislelizumab) in combination with the poly(adenosine diphosphate ribose) polymerase (PARP) inhibitor BGB-290 (pamiparib) in participants with advanced solid tumors.

Conditions
Solid Tumors
Being tested
Tislelizumab, Pamiparib
Keywords
Dose Escalation, Dose Expansion, BGB-A317, BGB-290, Tislelizumab, Pamiparib

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TislelizumabBiological

    Also called BGB-A317

  • PamiparibDrug

    Also called BGB-290

Study groups in NCT02660034
Study groupRoleWhat they receive
Part A: Dose Escalation PhaseExperimentalParticipants received tislelizumab and pamiparib (dose escalation) until determination of the maximum tolerated dose/recommended Phase 2 dose.
Receives: Biological: Tislelizumab; Drug: Pamiparib
Part B: Dose Expansion PhaseExperimentalParticipants received tislelizumab and pamiparib (dose expansion).
Receives: Biological: Tislelizumab; Drug: Pamiparib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part A: Number Of Participants Experiencing Adverse Events (AEs)

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

    Measured: From Day 1 up to 4 years and 7 months

  2. Part A: Number Of Participants Experiencing Dose-limiting Toxicity (DLT)

    DLT was defined as an AE or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications, and occurs during the first 21 days following the first dose of tislelizumab and pamiparib in Cycle 1 and meets protocol-specified criteria. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

    Measured: 21 days following the first dose of tislelizumab and pamiparib in Cycle 1

  3. Part B: Objective Response Rate (ORR)

    ORR was defined as the percentage of participants with a best overall response of complete response (CR) and partial response (PR).

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  4. Part B: Progression-free Survival (PFS)

    PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  5. Part B: Duration Of Response (DOR)

    DOR, defined as the time from the first determination of an objective response, was assessed by investigator per Response Evaluation Criteria in Solid Tumors v1.1 until the first documentation of progression or death, whichever occurred first. Results are reported only for arms with responders.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  6. Part B: Disease Control Rate (DCR)

    DCR was defined as the percentage of participants with a best overall response of CR, PR, and stable disease (SD).

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  7. Part B: Clinical Benefit Rate (CBR)

    CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  8. Part B: Overall Survival (OS)

    OS was defined as the time from the date of first dose of study drug to death due to any cause.

    Measured: From Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

Secondary outcomes (17)

  1. Part A: Minimum Observed Plasma Concentration (Ctrough) Of Tislelizumab

    Measured: Cycle 4 Day 1 (0 hours and 4 hours) post dose

  2. Part A: Ctrough Of Pamiparib

    Measured: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

  3. Part A: Maximum Observed Plasma Concentration At Steady State (Cmax,ss) Of Pamiparib

    Measured: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

  4. Part A: Time To Reach Maximum Plasma Concentration At Steady State (Tmax,ss) Of Pamiparib

    Measured: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

  5. Part A: Ctrough At Steady State (Ctrough,ss) Of Pamiparib

    Measured: Cycle 2 Day 1 (Pre-dose and 7 hours Post-dose)

  6. Part A: ORR

    ORR was defined as the percentage of participants with a best overall response of CR and PR.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  7. Part A: PFS

    PFS was defined as the time from first dose of study medication to the first documented objective disease progression or death due to any cause, whichever occurred first.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  8. Part A: DCR

    DCR was defined as the percentage of participants with a best overall response of CR, PR, and SD.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  9. Part A: CBR

    CBR was defined as the percentage of participants with a best overall response of CR, PR, and SD lasting ≥ 24 weeks.

    Measured: Starting from Day 1 until disease progression (up to 4 years and 7 months)

  10. Part A: OS

    OS was defined as the time from the date of first dose of study drug to death due to any cause.

    Measured: Starting from Day 1 Every 3 months following completion or discontinuation of the treatment (up to 4 years and 7 months)

  11. Part A: Percentage Of Participants With Anti-drug Antibodies (ADAs) For Tislelizumab

    Immunogenicity was summarized by participants who were ADA positive and developed detectable ADAs.

    Measured: Within 24 hours before the start of the first dose of tislelizumab in Cycle 1, Day 8 of Cycle 1, and Day 1 of Cycle 2, Cycle 3, Cycle 4, Cycle 5, Cycle 9, and Cycle 17

  12. Part B: Number Of Participants Experiencing AEs

    An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study drug, whether considered related to study drug or not. All AEs reported are treatment-emergent, which was defined as having a reported onset time or worsening in severity on or after the date of the first dose of study treatment through 30 days after the last dose (permanent discontinuation of study treatment) or initiation of new anticancer therapy. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.

    Measured: Day 1 of Cycle 1 up to 4 years and 7 months

  13. Part B: Ctrough Of Tislelizumab

    As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

    Measured: Cycle 4 Day 1 ( 0 hours and 4 hours post dose)

  14. Part B: Maximum Observed Plasma Concentration (Cmax) Of Tislelizumab

    As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

    Measured: Cycle 4 Day 1 ( 0 hours and 4 hours) post dose

  15. Part B: Ctrough Of Pamiparib

    As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

    Measured: Cycle 2 Day 1 (7 hours Post-dose)

  16. Part B: Cmax Of Pamiparib

    As pre-specified in the protocol, pharmacokinetic evaluations were performed for all Part B dose expansion arms combined.

    Measured: Cycle 2 (7 hours Post-dose)

  17. Part B: Percentage Of Participants With ADAs For Tislelizumab

    Immunogenicity was summarized by participants who developed detectable ADAs. Treatment-emergent ADAs: sum of both treatment-induced ADAs and treatment-boosted ADAs.

    Measured: 24 hours predose of Day 1 of every cycle

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2016 (estimated)
  2. Study start2 Feb 2016
  3. Primary completion9 Sep 2020
  4. Study completion9 Sep 2020

Resources

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
229 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02660034
Sponsor's protocol ID
BGB-A317/BGB-290_Study_001
Other IDs
2017-003580-35, 2017
Status last verified
Oct 2021
First submitted
11 Jan 2016
Last updated
6 Dec 2021
Individual data sharing
Yes

Publications

  • Friedlander M, Meniawy T, Markman B, Mileshkin L, Harnett P, Millward M, Lundy J, Freimund A, Norris C, Mu S, Wu J, Paton V, Gao B. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-escalation stage of a multicentre, open-label, phase 1a/b trial. Lancet Oncol. 2019 Sep;20(9):1306-1315. doi: 10.1016/S1470-2045(19)30396-1. Epub 2019 Aug 1.

    PubMed 31378459

  • Friedlander M, Mileshkin L, Lombard J, Frentzas S, Gao B, Wilson M, Meniawy T, Baron-Hay S, Briscoe K, McCarthy N, Fountzilas C, Cervantes A, Ge R, Wu J, Spira A. Pamiparib in combination with tislelizumab in patients with advanced solid tumours: results from the dose-expansion stage of a multicentre, open-label, phase I trial. Br J Cancer. 2023 Sep;129(5):797-810. doi: 10.1038/s41416-023-02349-0. Epub 2023 Jul 20.

    PubMed 37474720

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Tislelizumab and Pamiparib in people with Solid Tumors, run by BeiGene at 29 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 50 inclusion and 40 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 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States, Australia, France, New Zealand, Spain 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 6 Dec 2021). 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?

Part A: Number Of Participants Experiencing Adverse Events (AEs) (time frame: From Day 1 up to 4 years and 7 months). The study lists 8 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 NCT02660034, which also lists 2 linked publications.

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 6 Dec 2021.

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Clinical Trial NCT02660034 | AzTrials