Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT05981703

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

Led by BeOne Medicines · Updated on 2026-05-08

217

Participants Needed

27

Research Sites

210 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide signed informed consent before any study procedures
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Phase 1a: Histologically or cytologically confirmed advanced, metastatic, unresectable immune-sensitive solid tumors with prior standard systemic therapy or not suitable for treatment, and no prior HPK1-targeted therapy
  • Phase 1b: Histologically confirmed locally advanced unresectable or metastatic tumors without prior systemic treatment, or with prior curative neo-adjuvant or adjuvant therapy if disease-free for at least 6 months
  • At least 1 measurable lesion per RECIST v1.1
  • Able to provide archived tumor tissue sample
  • Adequate organ function
  • Females of childbearing potential willing to use highly effective birth control during the study and for at least 90 days after last BGB-26808 dose, 120 days after last tislelizumab dose, or 180 days after last chemotherapy dose
  • Nonsterile males willing to use highly effective birth control during the study treatment period and specified durations after last doses
Not Eligible

You will not qualify if you...

  • Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-TIGIT, anti-CTLA4, or other drugs targeting T-cell costimulation or checkpoint pathways
  • Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
  • Clinically significant gastrointestinal bleeding within 28 days before first study dose
  • Active leptomeningeal disease or uncontrolled, untreated brain metastasis
  • Active autoimmune diseases or history of autoimmune diseases that may relapse
  • Any malignancy within 3 years before first study dose except the cancer under study or certain locally recurring cancers treated with curative intent
  • Systemic corticosteroids (>10 mg prednisone daily or equivalent) or other immunosuppressive medications within 14 days before first study dose
  • History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis or acute lung diseases
  • Uncontrolled diabetes
  • Infection requiring systemic antibacterial, antifungal, or antiviral therapy within 14 days before first study dose
  • Other protocol defined inclusion/exclusion criteria may apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 27 locations

1

City of Hope National Medical Center

Duarte, California, United States, 91010-3012

Actively Recruiting

2

University of Southern California Norris Comprehensive

Los Angeles, California, United States, 90033

Actively Recruiting

3

Yale University, Yale Cancer Center

New Haven, Connecticut, United States, 06520-8028

Actively Recruiting

4

Sylvester Cancer Center, University of Miami

Miami, Florida, United States, 33136

Actively Recruiting

5

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601-2191

Actively Recruiting

6

Icahn School of Medicine At Mount Sinai

New York, New York, United States, 10029-6504

Actively Recruiting

7

Providence Portland Medical Center

Portland, Oregon, United States, 97213-2933

Actively Recruiting

8

The University of Texas Md Anderson Cancer Center

Houston, Texas, United States, 77030-4009

Actively Recruiting

9

Southside Cancer Care

Miranda, New South Wales, Australia, NSW 2228

Completed

10

Macquarie University

North Ryde, New South Wales, Australia, NSW 2109

Actively Recruiting

11

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, Australia, SA 5037

Actively Recruiting

12

Linear Clinical Research

Nedlands, Western Australia, Australia, WA 6009

Actively Recruiting

13

The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch

Hefei, Anhui, China, 230022

Actively Recruiting

14

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China, 150000

Actively Recruiting

15

Hubei Cancer Hospital

Wuhan, Hubei, China, 430079

Actively Recruiting

16

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

Wuhan, Hubei, China, 430101

Actively Recruiting

17

The First Hospital of China Medical University Hunnan Branch

Shenyang, Liaoning, China, 110167

Actively Recruiting

18

Jining No1 Peoples Hospital West Branch

Jining, Shandong, China, 272000

Actively Recruiting

19

Yantai Yuhuangding Hospital

Yantai, Shandong, China, 264000

Actively Recruiting

20

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, China, 200123

Actively Recruiting

21

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, China, 200433

Completed

22

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, China, 610071

Actively Recruiting

23

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, China, 310006

Actively Recruiting

24

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang, China, 317004

Completed

25

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

26

Harbour Cancer and Wellness

Auckland, New Zealand, 1023

Actively Recruiting

27

Health New Zealand Te Whatu Ora Lakes Rotorua Hospital

Rotorua, New Zealand, 3010

Actively Recruiting

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Research Team

S

Study Director

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

2

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