A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors
NCT ID: NCT05981703
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
217 participants
INTERVENTIONAL
2023-09-21
2027-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Phase 1a: Dose Escalation
Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.
BGB-26808
Planned doses administered orally as a tablet daily.
Tislelizumab
Planned doses administered by intravenous infusion.
Phase 1b: Dose Expansion
Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.
BGB-26808
Planned doses administered orally as a tablet daily.
Tislelizumab
Planned doses administered by intravenous infusion.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Interventions
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BGB-26808
Planned doses administered orally as a tablet daily.
Tislelizumab
Planned doses administered by intravenous infusion.
Chemotherapy
Administered in accordance with relevant local guidelines and/or prescribing information.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 ≥ 180 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
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).
18 Years
ALL
No
Sponsors
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BeiGene
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
BeiGene
Locations
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Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Sylvester Cancer Center, University of Miami
Miami, Florida, United States
John Theurer Cancer Center Hackensack University Medical Center
Hackensack, New Jersey, United States
Icahn School of Medicine At Mount Sinai
New York, New York, United States
Providence Portland Medical Center
Portland, Oregon, United States
The University of Texas Md Anderson Cancer Center
Houston, Texas, United States
Southside Cancer Care
Miranda, New South Wales, Australia
Macquarie University
North Ryde, New South Wales, Australia
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
Hefei, Anhui, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China
Hubei Cancer Hospital
Wuhan, Hubei, China
Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
Wuhan, Hubei, China
The First Hospital of China Medical University Hunnan Branch
Shenyang, Liaoning, China
Jining No Peoples Hospital West Branch
Jining, Shandong, China
Yantai Yuhuangding Hospital
Yantai, Shandong, China
Shanghai East Hospital Branch Hospital
Shanghai, Shanghai Municipality, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
Chengdu, Sichuan, China
Hangzhou First Peoples Hospital
Hangzhou, Zhejiang, China
Taizhou Hospital of Zhejiang Province (East)
Taizhou, Zhejiang, China
Auckland City Hospital
Auckland, , New Zealand
Harbour Cancer and Wellness
Auckland, , New Zealand
Countries
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Central Contacts
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Other Identifiers
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CTR20240210
Identifier Type: OTHER
Identifier Source: secondary_id
BGB-A317-26808-101
Identifier Type: -
Identifier Source: org_study_id
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