Back to Trials
NCT05981703PHASE1Recruiting

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

BeOne Medicines

Start Date

9/21/2023

Completion Date

9/30/2027

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.

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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 ≥ 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: 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.

Interventions

DRUG

BGB-26808

DRUG

Tislelizumab

DRUG

Chemotherapy

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Advanced Solid TumorSolid Tumor

Locations

City of Hope National Medical Center

Duarte, California 91010-3012

United States

University of Southern California Norris Comprehensive

Los Angeles, California 90033

United States

Yale University Yale Cancer Center

New Haven, Connecticut 06520-8028

United States

Sylvester Cancer Center, University of Miami

Miami, Florida 33136

United States

University of Michigan Health System

Ann Arbor, Michigan 48109-5316

United States

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey 07601

United States

Icahn School of Medicine At Mount Sinai

New York, New York 10029-6504

United States

Providence Portland Medical Center

Portland, Oregon 97213-2933

United States

The University of Texas Md Anderson Cancer Center

Houston, Texas 77030-4009

United States

Southside Cancer Care

Miranda, New South Wales NSW 2228

Australia

Macquarie University

North Ryde, New South Wales NSW 2109

Australia

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia SA 5037

Australia

Linear Clinical Research

Nedlands, Western Australia WA 6009

Australia

The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch

Hefei, Anhui 230022

China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang 150000

China

Hubei Cancer Hospital

Wuhan, Hubei 430079

China

Tongji Hospital,Tongji Medical College of Hustsino French New City Branch

Wuhan, Hubei 430101

China

The First Hospital of China Medical University Hunnan Branch

Shenyang, Liaoning 110167

China

Jining No1 Peoples Hospital West Branch

Jining, Shandong 272000

China

Yantai Yuhuangding Hospital

Yantai, Shandong 264000

China

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality 200123

China

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality 200433

China

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan 610071

China

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang 310006

China

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang 317004

China

Auckland City Hospital

Auckland, 1023

New Zealand

Harbour Cancer and Wellness

Auckland, 1023

New Zealand

Health New Zealand Te Whatu Ora Lakes Rotorua Hospital

Rotorua, 3010

New Zealand