Recruiting
Phase 1

BGB-26808 & Tislelizumab

Sponsor:

BeOne Medicines

Code:

NCT05981703

Conditions

Advanced Solid Tumor

Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

BGB-26808

Tislelizumab

Chemotherapy

Study Details

Brief 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.

Conditions

Advanced Solid Tumor

Solid Tumor

Study ID

NCT05981703

Start date

Sep 21, 2023

Status verified date

Aug, 2026

Completion date

Feb 28, 2029

Anticipated

Primary completion date

Feb 28, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

337 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Phase 1a: Dose Escalation

Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.

experimental: Phase 1b: Dose Expansion

Recommended doses for expansion (RDFEs) for BGB-26808 from Phase 1a in combination with tislelizumab plus chemotherapy will be evaluated.

Interventions

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.

Primary outcome measure

  • Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 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 ]
  • Phase 1a: Maximum Tolerated Dose (MTD) or Maximum Administered Dose (MAD) of BGB-26808 [ Time Frame: Approximately 1 month ]
  • Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808 [ Time Frame: Approximately 1 month ]
  • Phase 1b: Overall Response Rate (ORR) [ Time Frame: Approximately 6 months ]

Central Contacts and Locations

Central contacts

Locations

City of Hope National Medical Center

Recruiting

Duarte, California, United States, 91010-3012

University of Southern California Norris Comprehensive

Recruiting

Los Angeles, California, United States, 90033

Yale University Yale Cancer Center

Recruiting

New Haven, Connecticut, United States, 06520-8028

Sylvester Cancer Center, University of Miami

Recruiting

Miami, Florida, United States, 33136

University of Michigan Health System

Recruiting

Ann Arbor, Michigan, United States, 48109-5316

John Theurer Cancer Center Hackensack University Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

Icahn School of Medicine At Mount Sinai

Recruiting

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

Providence Portland Medical Center

Recruiting

Portland, Oregon, United States, 97213-2933

The University of Texas Md Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030-4009

More Information

Sponsor

BeOne Medicines

Last update posted

Sep 1, 2026

Last verified

Aug, 2026

Keywords

  • advanced solid tumor
  • BGB-26808
  • BGB-A317
  • Tislelizumab
  • PD1
  • HPK1

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BeOne Medicines on 2026-09-01.