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Recruiting Phase 1

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

NCT05981703 · tracked via the Priya Life Science China tracker
Phase
Phase 1
Started
2023-09-21
Last updated
2026-09-28

Condition(s) studied

Advanced Solid TumorSolid Tumor

Investigational drug(s) / intervention(s)

BGB-26808Tislelizumab →Chemotherapy

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) — 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
    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.
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808 — Approximately 1 month
    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.
  • Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808 — Approximately 1 month
    RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.
  • Phase 1b: Overall Response Rate (ORR) — Approximately 6 months
    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.

Trial sites (28)

FacilityCityRegionStatus
City of Hope National Medical Center Duarte California Recruiting
University of Southern California Norris Comprehensive Los Angeles California Recruiting
Yale University Yale Cancer Center New Haven Connecticut Recruiting
Sylvester Cancer Center, University of Miami Miami Florida Recruiting
University of Michigan Health System Ann Arbor Michigan Recruiting
John Theurer Cancer Center Hackensack University Medical Center Hackensack New Jersey Recruiting
Icahn School of Medicine At Mount Sinai New York New York Recruiting
Providence Portland Medical Center Portland Oregon Completed
The University of Texas Md Anderson Cancer Center Houston Texas Recruiting
Southside Cancer Care Miranda New South Wales Completed
Macquarie University North Ryde New South Wales Active Not Recruiting
Icon Cancer Centre Kurralta Park Kurralta Park South Australia Active Not Recruiting
Linear Clinical Research Nedlands Western Australia Completed
The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch Hefei Anhui Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
Hubei Cancer Hospital Wuhan Hubei Recruiting
Tongji Hospital,Tongji Medical College of Hustsino French New City Branch Wuhan Hubei Recruiting
The First Hospital of China Medical University Hunnan Branch Shenyang Liaoning Recruiting
Jining No1 Peoples Hospital West Branch Jining Shandong Recruiting
Yantai Yuhuangding Hospital Yantai Shandong Recruiting
Shanghai East Hospital Branch Hospital Shanghai Shanghai Municipality Recruiting
Shanghai Pulmonary Hospital Shanghai Shanghai Municipality Completed
Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital Chengdu Sichuan Recruiting
Hangzhou First Peoples Hospital Hangzhou Zhejiang Recruiting
Taizhou Hospital of Zhejiang Province (East) Taizhou Zhejiang 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
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05981703 on ClinicalTrials.gov ↗ ← All trials in China