The EDC is live today — see what ships now
All studies
NCT05981703From ClinicalTrials.govRecruiting

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

A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of HPK1 Inhibitor BGB-26808 Alone or in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors

  • Advanced Solid Tumor
  • Solid Tumor

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
BeOne Medicines
Enrolment target
337
Started
21 September 2023
Main results due
28 February 2029
Study sites
28
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(28)

  • City of Hope National Medical Center

    Duarte, California, United States

    Recruiting

  • University of Southern California Norris Comprehensive

    Los Angeles, California, United States

    Recruiting

  • Yale University Yale Cancer Center

    New Haven, Connecticut, United States

    Recruiting

  • Sylvester Cancer Center, University of Miami

    Miami, Florida, United States

    Recruiting

  • University of Michigan Health System

    Ann Arbor, Michigan, United States

    Recruiting

  • John Theurer Cancer Center Hackensack University Medical Center

    Hackensack, New Jersey, United States

    Recruiting

  • Icahn School of Medicine At Mount Sinai

    New York, New York, United States

    Recruiting

  • Providence Portland Medical Center

    Portland, Oregon, United States

    Completed

  • The University of Texas Md Anderson Cancer Center

    Houston, Texas, United States

    Recruiting

  • Southside Cancer Care

    Miranda, New South Wales, Australia

    Completed

  • Macquarie University

    North Ryde, New South Wales, Australia

    Active, not recruiting

  • Icon Cancer Centre Kurralta Park

    Kurralta Park, South Australia, Australia

    Active, not recruiting

  • Linear Clinical Research

    Nedlands, Western Australia, Australia

    Completed

  • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch

    Hefei, Anhui, China

    Recruiting

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

    Recruiting

  • Hubei Cancer Hospital

    Wuhan, Hubei, China

    Recruiting

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

    Wuhan, Hubei, China

    Recruiting

  • The First Hospital of China Medical University Hunnan Branch

    Shenyang, Liaoning, China

    Recruiting

  • Jining No1 Peoples Hospital West Branch

    Jining, Shandong, China

    Recruiting

  • Yantai Yuhuangding Hospital

    Yantai, Shandong, China

    Recruiting

  • Shanghai East Hospital Branch Hospital

    Shanghai, Shanghai Municipality, China

    Recruiting

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, China

    Completed

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, China

    Recruiting

  • Hangzhou First Peoples Hospital

    Hangzhou, Zhejiang, China

    Recruiting

  • Taizhou Hospital of Zhejiang Province (East)

    Taizhou, Zhejiang, China

    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

Showing 28 of 28 sites. 21 of the 28 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT05981703. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me
A Study Investigating BGB-26808 Alone or in Combination With Tislelizumab in Participants With Advanced Solid | Trialion