Advanced Solid TumorPhase 1NCT05981703
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
A Phase 1 study testing BGB-26808, Tislelizumab and Chemotherapy in people with Advanced Solid Tumor and Solid Tumor, run by BeOne Medicines at 28 sites in 4 countries.
Trial summary
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor, Solid Tumor
- What is being tested?
- BGB-26808, Tislelizumab and Chemotherapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 337 participants
- Where
- 28 sitesin 4 countries
- Study dates
- 21 Sep 2023to 28 Feb 2029
- Phase
- Phase 1
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
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
- Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
- Phase 1a: Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have previously received standard systemic therapy, or for whom treatment is not available or not tolerated, or for whom treatment is determined not appropriate based on investigator's judgment and who have not received prior therapy targeting hematopoietic progenitor kinase 1 (HPK1).
- Phase 1b: Participants with histologically confirmed locally advanced unresectable or metastatic tumor types and who have not had prior systemic treatment. Participants who received prior systemic therapy in a neo-adjuvant or adjuvant setting with curative intent for nonmetastatic disease must have experienced a disease-free interval of ≥ 6 months from the last dose of systemic therapy prior to the first dose of study treatments.
- ≥ 1 measurable lesion per RECIST v1.1.
- Able to provide an archived tumor tissue sample.
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- Adequate organ function.
- Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for up to ≥ 270 days after the last dose of chemotherapy.
- Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 90 days after the last dose of BGB-26808, or for ≥ 120 days after the last dose of tislelizumab, or for ≥ 180 days after the last dose of chemotherapy.
Who cannot join
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or any other antibody or drug specifically targeting T-cell costimulation or checkpoint pathways.
- Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
- Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
- Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
- Active autoimmune diseases or history of autoimmune diseases that may relapse
- Any malignancy ≤ 3 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).
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- Any condition that required systemic treatment with either corticosteroids (> 10 mg daily of prednisone or equivalent) or other immunosuppressive medication ≤ 14 days before the first dose of study treatment(s).
- History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
- Uncontrolled diabetes.
- Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
28 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 4 countries
China12 sites, 10 recruiting
- Recruiting
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, 610071
- Recruiting
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, 310006
- Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
- Recruiting
The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
Hefei, Anhui, 230022
- Recruiting
Jining No1 Peoples Hospital West Branch
Jining, Shandong, 272000
- Recruiting
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, 200123
- Completed
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
- Recruiting
The First Hospital of China Medical University Hunnan Branch
Shenyang, Liaoning, 110167
- Completed
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, 317004
- Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, 430079
- Recruiting
Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
Wuhan, Hubei, 430101
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
United States9 sites, 8 recruiting
- Recruiting
University of Michigan Health System
Ann Arbor, Michigan, 48109-5316
- Recruiting
City of Hope National Medical Center
Duarte, California, 91010-3012
- Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, 07601
- Recruiting
The University of Texas Md Anderson Cancer Center
Houston, Texas, 77030-4009
- Recruiting
University of Southern California Norris Comprehensive
Los Angeles, California, 90033
- Recruiting
Sylvester Cancer Center, University of Miami
Miami, Florida, 33136
- Recruiting
Yale University Yale Cancer Center
New Haven, Connecticut, 06520-8028
- Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York, 10029-6504
- Completed
Providence Portland Medical Center
Portland, Oregon, 97213-2933
Australia4 sites
- Active, not recruiting
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, SA 5037
- Completed
Southside Cancer Care
Miranda, New South Wales, NSW 2228
- Completed
Linear Clinical Research
Nedlands, Western Australia, WA 6009
- Active, not recruiting
Macquarie University
North Ryde, New South Wales, NSW 2109
New Zealand3 sites, 3 recruiting
- Recruiting
Auckland City Hospital
Auckland, 1023
- Recruiting
Harbour Cancer and Wellness
Auckland, 1023
- Recruiting
Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
Rotorua, 3010
About this study
Official title: A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors
This is an open-label, multicenter, and nonrandomized dose escalation and dose expansion study to evaluate BGB-26808 as monotherapy or in combination with tislelizumab in participants with advanced solid tumors. The main purpose of this study is to explore the recommended dosing for BGB-26808.
Read the detailed description
Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.
- Conditions
- Advanced Solid Tumor, Solid Tumor
- Being tested
- BGB-26808, Tislelizumab, Chemotherapy
- Keywords
- advanced solid tumor, BGB-26808, BGB-A317, Tislelizumab, PD1, HPK1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BGB-26808Drug
Planned doses administered orally as a tablet daily.
TislelizumabDrug
Also called BGB-A317
Planned doses administered by intravenous infusion.
ChemotherapyDrug
Administered in accordance with relevant local guidelines and/or prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a: Dose Escalation | Experimental | Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab. Receives: Drug: BGB-26808; Drug: Tislelizumab |
| Phase 1b: Dose Expansion | Experimental | Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated. Receives: Drug: BGB-26808; Drug: Tislelizumab; Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Measured: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808
MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.
Measured: Approximately 1 month
Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808
RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
Measured: Approximately 1 month
Phase 1b: Overall Response Rate (ORR)
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Measured: Approximately 6 months
Secondary outcomes (10)
Phase 1a: ORR
ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.
Measured: Approximately 6 months
Phase 1a and 1b: Duration of Response (DOR)
DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.
Measured: Approximately 9 months
Phase 1a and 1b: Disease Control Rate (DCR)
DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.
Measured: Approximately 6 months
Phase 1a and 1b: Clinical Benefit Rate (CBR)
CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.
Measured: Approximately 6 months
Phase 1b: Progression Free Survival (PFS)
PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.
Measured: Approximately 9 months
Phase 1a and 1b: Plasma concentrations of BGB-26808
Measured: Approximately 6 months
Phase 1a and 1b: Maximum observed plasma concentration (Cmax) for BGB-26808
Measured: Approximately 1 month
Phase 1a and 1b: Time to maximum plasma concentration (Tmax) for BGB-26808
Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.
Measured: Approximately 1 month
Phase 1a and 1b: Area under the concentration-time curve (AUC) for BGB-26808
Measured: Approximately 1 month
Phase 1b: Number of Participants with AEs and SAEs
Number of participants with AEs and SAEs, including findings from physical examinations, ECGs, laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.
Measured: From the first dose of study drug(s) to 90 days after the last dose or initiation of a new anticancer therapy, whichever occurs first; up to approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start21 Sep 2023
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by BeOne MedicinesThe 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
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 337 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BeOne Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, BeOne Medicines
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05981703
- Sponsor's protocol ID
- BGB-A317-26808-101
- Other IDs
- CTR20240210
- Status last verified
- Sep 2026
- First submitted
- 31 Jul 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: BeOne 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. BeOne 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 BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.