A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid Tumors

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Solid Tumor

In brief

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.

Key facts

Study ID

NCT05981703

Run by

BeOne Medicines

People needed

217

Starts

2023-09-21

Expected to finish

2027-09-30

Last updated by the study team

2026-06-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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 ≥ 180 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.

You may not qualify if…

• 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).
• 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.

Where it is running

• Health New Zealand Te Whatu Ora Lakes Rotorua Hospital — Rotorua, New Zealand (enrolling)
• University of Southern California Norris Comprehensive — Los Angeles, California, United States (enrolling)
• Yale University Yale Cancer Center — New Haven, Connecticut, United States (enrolling)
• Sylvester Cancer Center, University of Miami — Miami, Florida, United States (enrolling)
• University of Michigan Health System — Ann Arbor, Michigan, United States (enrolling)
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States (enrolling)
• Icahn School of Medicine At Mount Sinai — New York, New York, United States (enrolling)
• Providence Portland Medical Center — Portland, Oregon, United States (enrolling)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Auckland City Hospital — Auckland, New Zealand (enrolling)
• Harbour Cancer and Wellness — Auckland, New Zealand (enrolling)
• City of Hope National Medical Center — Duarte, California, United States (enrolling)
• Macquarie University — North Ryde, New South Wales, Australia (enrolling)
• Icon Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia (enrolling)
• Linear Clinical Research — Nedlands, Western Australia, Australia (enrolling)
• The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch — Hefei, Anhui, China (enrolling)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (enrolling)
• Hubei Cancer Hospital — Wuhan, Hubei, China (enrolling)
• Tongji Hospital,Tongji Medical College of Hustsino French New City Branch — Wuhan, Hubei, China (enrolling)
• The First Hospital of China Medical University Hunnan Branch — Shenyang, Liaoning, China (enrolling)
• Jining No1 Peoples Hospital West Branch — Jining, Shandong, China (enrolling)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (enrolling)
• Shanghai East Hospital Branch Hospital — Shanghai, Shanghai Municipality, China (enrolling)
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China (enrolling)
• Hangzhou First Peoples Hospital — Hangzhou, Zhejiang, China (enrolling)

Full record on ClinicalTrials.gov

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