A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
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
- Advanced Solid Tumor
- Solid Tumor
At a glance
- Phase
- Phase 1
- Study type
- Interventional
- Sponsor
- BeOne Medicines
- Enrolment target
- 337
- Started
- 21 September 2023
- Main results due
- 28 February 2029
- Study sites
- 28
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria: 1. Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection. 2. Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1. 3. 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). 4. 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. 5. ≥ 1 measurable lesion per RECIST v1.1. 6. Able to provide an archived tumor tissue sample. 7. Adequate organ function. 8. 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. 9. 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. Exclusion Criteria: 1. 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. 2. Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention. 3. Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s). 4. Active leptomeningeal disease or uncontrolled, untreated brain metastasis. 5. Active autoimmune diseases or history of autoimmune diseases that may relapse 6. 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). 7. 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). 8. History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases. 9. Uncontrolled diabetes. 10. 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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(28)
City of Hope National Medical Center
Duarte, California, United States
Recruiting
University of Southern California Norris Comprehensive
Los Angeles, California, United States
Recruiting
Yale University Yale Cancer Center
New Haven, Connecticut, United States
Recruiting
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
Recruiting
University of Michigan Health System
Ann Arbor, Michigan, United States
Recruiting
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Recruiting
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Recruiting
Providence Portland Medical Center
Portland, Oregon, United States
Completed
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Recruiting
Southside Cancer Care
Miranda, New South Wales, Australia
Completed
Macquarie University
North Ryde, New South Wales, Australia
Active, not recruiting
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Active, not recruiting
Linear Clinical Research
Nedlands, Western Australia, Australia
Completed
The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
Hefei, Anhui, China
Recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Recruiting
Hubei Cancer Hospital
Wuhan, Hubei, China
Recruiting
Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
Wuhan, Hubei, China
Recruiting
The First Hospital of China Medical University Hunnan Branch
Shenyang, Liaoning, China
Recruiting
Jining No1 Peoples Hospital West Branch
Jining, Shandong, China
Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Recruiting
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China
Recruiting
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Completed
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Recruiting
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, China
Recruiting
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, China
Completed
Auckland City Hospital
Auckland, New Zealand
Recruiting
Harbour Cancer and Wellness
Auckland, New Zealand
Recruiting
Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
Rotorua, New Zealand
Recruiting
Showing 28 of 28 sites. 21 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05981703. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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