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New drug combo targets Hard-to-Treat cancers in early trial

NCT ID NCT05981703

Disease control Sponsor: BeOne Medicines Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Sep 15, 2026 · Updated 5 times

Summary

This early-phase study is testing a new drug called BGB-26808, either alone or with another drug (tislelizumab), in people with advanced solid tumors that have not responded to standard treatments. The main goal is to find a safe dose and check for side effects. About 217 participants will take part across multiple centers.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
BGB-26808 (HPK1 inhibitor) and tislelizumab (anti-PD-1 antibody)
What this could lead to
If successful, this could lead to a new treatment option for people with advanced solid tumors that have stopped responding to other therapies.
What could go wrong
This is an early Phase 1 trial focused on safety and dosing, so it is too soon to know if the drug will work. Side effects are possible, and the drug may not shrink tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 337 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2023

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced solid tumor Solid tumor

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    24 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Auckland City Hospital

    RECRUITING

    Auckland, 1023, New Zealand

  • City of Hope National Medical Center

    RECRUITING

    Duarte, California, 91010-3012, United States

  • Hangzhou First Peoples Hospital

    RECRUITING

    Hangzhou, Zhejiang, 310006, China

  • Harbin Medical University Cancer Hospital

    RECRUITING

    Harbin, Heilongjiang, 150000, China

  • Harbour Cancer and Wellness

    RECRUITING

    Auckland, 1023, New Zealand

  • Health New Zealand Te Whatu Ora Lakes Rotorua Hospital

    RECRUITING

    Rotorua, 3010, New Zealand

  • Hubei Cancer Hospital

    RECRUITING

    Wuhan, Hubei, 430079, China

  • Icahn School of Medicine At Mount Sinai

    RECRUITING

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

  • Icon Cancer Centre Kurralta Park

    RECRUITING

    Kurralta Park, South Australia, SA 5037, Australia

  • Jining No1 Peoples Hospital West Branch

    RECRUITING

    Jining, Shandong, 272000, China

  • John Theurer Cancer Center Hackensack University Medical Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Linear Clinical Research

    RECRUITING

    Nedlands, Western Australia, WA 6009, Australia

  • Macquarie University

    RECRUITING

    North Ryde, New South Wales, NSW 2109, Australia

  • Providence Portland Medical Center

    COMPLETED

    Portland, Oregon, 97213-2933, United States

  • Shanghai East Hospital Branch Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200123, China

  • Shanghai Pulmonary Hospital

    COMPLETED

    Shanghai, Shanghai Municipality, 200433, China

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    RECRUITING

    Chengdu, Sichuan, 610071, China

  • Southside Cancer Care

    COMPLETED

    Miranda, New South Wales, NSW 2228, Australia

  • Sylvester Cancer Center, University of Miami

    RECRUITING

    Miami, Florida, 33136, United States

  • Taizhou Hospital of Zhejiang Province (East)

    COMPLETED

    Taizhou, Zhejiang, 317004, China

  • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch

    RECRUITING

    Hefei, Anhui, 230022, China

  • The First Hospital of China Medical University Hunnan Branch

    RECRUITING

    Shenyang, Liaoning, 110167, China

  • The University of Texas Md Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030-4009, United States

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

    RECRUITING

    Wuhan, Hubei, 430101, China

  • University of Michigan Health System

    RECRUITING

    Ann Arbor, Michigan, 48109-5316, United States

  • University of Southern California Norris Comprehensive

    RECRUITING

    Los Angeles, California, 90033, United States

  • Yale University Yale Cancer Center

    RECRUITING

    New Haven, Connecticut, 06520-8028, United States

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.