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

NCT05981703 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: BGB-A317-26808-101CTR20240210
• Study Type: interventional
• Target: 217
• Locations: 4 countries
• Sites: 27

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

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Phase 1a: Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)

  Number of participants with AEs and SAEs, including findings from physical examinations, electrocardiograms (ECGs), laboratory assessments, and that meet protocol-defined dose-limiting toxicity criteria.

  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

  MTD is defined as the highest dose evaluated for which estimated toxicity rate is the closest to the target toxicity rate. MAD is defined as the highest dose administered if MTD is not reached.

  Approximately 1 month

• Phase 1a: Recommended Dose for Expansion (RDFE) of BGB-26808

  RDFE of BGB-26808 alone or in combination with tislelizumab will be determined based upon the MTD or MAD.

  Approximately 1 month

• Phase 1b: Overall Response Rate (ORR)

  ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Approximately 6 months

Secondary Outcomes (15)

• Phase 1a: ORR

  Approximately 6 months

• Phase 1a and 1b: Duration of Response (DOR)

  Approximately 9 months

• Phase 1a and 1b: Disease Control Rate (DCR)

  Approximately 6 months

• Phase 1a and 1b: Clinical Benefit Rate (CBR)

  Approximately 6 months

• Phase 1b: Progression Free Survival (PFS)

  Approximately 9 months

Study Arms (2)

Phase 1a: Dose Escalation

EXPERIMENTAL

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

Drug: BGB-26808; Drug: Tislelizumab

Phase 1b: Dose Expansion

EXPERIMENTAL

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

Drug: BGB-26808; Drug: Tislelizumab; Drug: Chemotherapy

Interventions

BGB-26808 DRUG

Planned doses administered orally as a tablet daily.

Phase 1a: Dose Escalation; Phase 1b: Dose Expansion

Tislelizumab DRUG

Planned doses administered by intravenous infusion.

Also known as: BGB-A317

Phase 1a: Dose Escalation; Phase 1b: Dose Expansion

Chemotherapy DRUG

Administered in accordance with relevant local guidelines and/or prescribing information.

Phase 1b: Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
• 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).
• 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.
• ≥ 1 measurable lesion per RECIST v1.1.
• Able to provide an archived tumor tissue sample.
• Adequate organ function.
• 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.
• 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.

You may not qualify if:

• 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.
• Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
• Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
• Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
• Active autoimmune diseases or history of autoimmune diseases that may relapse
• 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).
• 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).
• History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
• Uncontrolled diabetes.
• Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).

Sponsors & Collaborators

• BeOne Medicines: lead

Study Sites (27)

City of Hope National Medical Center

Duarte, California, 91010-3012, United States

RECRUITING

University of Southern California Norris Comprehensive

Los Angeles, California, 90033, United States

RECRUITING

Yale University, Yale Cancer Center

New Haven, Connecticut, 06520-8028, United States

RECRUITING

Sylvester Cancer Center, University of Miami

Miami, Florida, 33136, United States

RECRUITING

John Theurer Cancer Center Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Icahn School of Medicine At Mount Sinai

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

RECRUITING

Providence Portland Medical Center

Portland, Oregon, 97213-2933, United States

RECRUITING

The University of Texas Md Anderson Cancer Center

Houston, Texas, 77030-4009, United States

RECRUITING

Southside Cancer Care

Miranda, New South Wales, NSW 2228, Australia

COMPLETED

Macquarie University

North Ryde, New South Wales, NSW 2109, Australia

RECRUITING

Icon Cancer Centre Kurralta Park

Kurralta Park, South Australia, SA 5037, Australia

RECRUITING

Linear Clinical Research

Nedlands, Western Australia, WA 6009, Australia

RECRUITING

The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch

Hefei, Anhui, 230022, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150000, China

RECRUITING

Hubei Cancer Hospital

Wuhan, Hubei, 430079, China

RECRUITING

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

Wuhan, Hubei, 430101, China

RECRUITING

The First Hospital of China Medical University Hunnan Branch

Shenyang, Liaoning, 110167, China

RECRUITING

Jining No1 Peoples Hospital West Branch

Jining, Shandong, 272000, China

RECRUITING

Yantai Yuhuangding Hospital

Yantai, Shandong, 264000, China

RECRUITING

Shanghai East Hospital Branch Hospital

Shanghai, Shanghai Municipality, 200123, China

RECRUITING

Shanghai Pulmonary Hospital

Shanghai, Shanghai Municipality, 200433, China

COMPLETED

Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

Chengdu, Sichuan, 610071, China

RECRUITING

Hangzhou First Peoples Hospital

Hangzhou, Zhejiang, 310006, China

RECRUITING

Taizhou Hospital of Zhejiang Province (East)

Taizhou, Zhejiang, 317004, China

COMPLETED

Auckland City Hospital

Auckland, 1023, New Zealand

RECRUITING

Harbour Cancer and Wellness

Auckland, 1023, New Zealand

RECRUITING

Health New Zealand Te Whatu Ora Lakes Rotorua Hospital

Rotorua, 3010, New Zealand

RECRUITING

MeSH Terms

Interventions

tislelizumab; Drug Therapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Study Director

  BeOne Medicines

  STUDY DIRECTOR

Central Study Contacts

Study Director

CONTACT

1.877.828.5568; clinicaltrials@beonemed.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 31, 2023
• First Posted: August 8, 2023
• Study Start: September 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: See plan description
• Access Criteria: See plan description

Locations

NZ (3); AU (4); CN (12); US (8)