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

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 Overview

• Status: Recruiting
• Conditions: Solid Tumor; Advanced Solid Tumor
• Intervention / Treatment: Drug: BGB-26808; Drug: Tislelizumab; Drug: Chemotherapy

Detailed Description

Our company, previously known as BeiGene, is now officially BeOne Medicines. Because some of our older studies were sponsored under the name BeiGene, you may see both names used for this study on this website.

• Study Type: Interventional
• Enrollment (Estimated): 217
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Study Director; Phone Number: 1.877.828.5568; Email: clinicaltrials@beonemed.com

Study Locations

• Australia
  • New South Wales
    • Miranda, New South Wales, Australia, NSW 2228
      • Completed
      • Southside Cancer Care
    • North Ryde, New South Wales, Australia, NSW 2109
      • Recruiting
      • Macquarie University
  • South Australia
    • Kurralta Park, South Australia, Australia, SA 5037
      • Recruiting
      • Icon Cancer Centre Kurralta Park
  • Western Australia
    • Nedlands, Western Australia, Australia, WA 6009
      • Recruiting
      • Linear Clinical Research
• China
  • Anhui
    • Hefei, Anhui, China, 230022
      • Recruiting
      • The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150000
      • Recruiting
      • Harbin medical university cancer hospital
  • Hubei
    • Wuhan, Hubei, China, 430079
      • Recruiting
      • Hubei Cancer Hospital
    • Wuhan, Hubei, China, 430101
      • Recruiting
      • Tongji Hospital,Tongji Medical College of Hustsino French New City Branch
  • Liaoning
    • Shenyang, Liaoning, China, 110167
      • Recruiting
      • The First Hospital of China Medical University Hunnan Branch
  • Shandong
    • Jining, Shandong, China, 272000
      • Recruiting
      • Jining No1 Peoples Hospital West Branch
    • Yantai, Shandong, China, 264000
      • Recruiting
      • Yantai Yuhuangding Hospital
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200123
      • Recruiting
      • Shanghai East Hospital Branch Hospital
    • Shanghai, Shanghai Municipality, China, 200433
      • Completed
      • Shanghai Pulmonary Hospital
  • Sichuan
    • Chengdu, Sichuan, China, 610071
      • Recruiting
      • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310006
      • Recruiting
      • Hangzhou First Peoples Hospital
    • Taizhou, Zhejiang, China, 317004
      • Completed
      • Taizhou Hospital of Zhejiang Province (East)
• New Zealand
  • Auckland, New Zealand, 1023
    • Recruiting
    • Auckland City Hospital
  • Auckland, New Zealand, 1023
    • Recruiting
    • Harbour Cancer and Wellness
  • Rotorua, New Zealand, 3010
    • Recruiting
    • Health New Zealand Te Whatu Ora Lakes Rotorua Hospital
• United States
  • California
    • Duarte, California, United States, 91010-3012
      • Recruiting
      • City of Hope National Medical Center
    • Los Angeles, California, United States, 90033
      • Recruiting
      • University of Southern California Norris Comprehensive
  • Connecticut
    • New Haven, Connecticut, United States, 06520-8028
      • Recruiting
      • Yale University Yale Cancer Center
  • Florida
    • Miami, Florida, United States, 33136
      • Recruiting
      • Sylvester Cancer Center, University of Miami
  • Michigan
    • Ann Arbor, Michigan, United States, 48109-5316
      • Recruiting
      • University of Michigan Health System
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Recruiting
      • John Theurer Cancer Center Hackensack University Medical Center
  • New York
    • New York, New York, United States, 10029-6504
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
  • Oregon
    • Portland, Oregon, United States, 97213-2933
      • Recruiting
      • Providence Portland Medical Center
  • Texas
    • Houston, Texas, United States, 77030-4009
      • Recruiting
      • The University of Texas MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 ≥ 180 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Phase 1a: Dose Escalation; Sequential cohorts of increasing dose levels of BGB-26808 will be evaluated as monotherapy and in combination with tislelizumab.	Drug: BGB-26808; Planned doses administered orally as a tablet daily.; Drug: Tislelizumab; Planned doses administered by intravenous infusion.; Other Names: BGB-A317
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.	Drug: BGB-26808; Planned doses administered orally as a tablet daily.; Drug: Tislelizumab; Planned doses administered by intravenous infusion.; Other Names: BGB-A317; Drug: Chemotherapy; Administered in accordance with relevant local guidelines and/or prescribing information.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase 1a: ORR	ORR is defined as the percentage of participants who had confirmed complete response (CR) or partial response (PR) assessed by the investigator using RECIST v1.1.	Approximately 6 months
Phase 1a and 1b: Duration of Response (DOR)	DOR is defined as the time from the first determination of an objective response per RECIST v1.1 until the first documentation of disease progression or death, whichever occurs first as assessed by the investigator.	Approximately 9 months
Phase 1a and 1b: Disease Control Rate (DCR)	DCR is defined as the percentage of participants with best overall response of CR, PR, or stable disease. It will be summarized similarly as ORR as assessed by the investigator.	Approximately 6 months
Phase 1a and 1b: Clinical Benefit Rate (CBR)	CBR is defined as the percentage of participants with best overall response of confirmed CR, PR, or stable disease lasting ≥ 24 weeks as assessed by investigator.	Approximately 6 months
Phase 1b: Progression Free Survival (PFS)	PFS is defined as the time from the date of the first dose of study drug(s) to the date of the first documentation of progressive disease assessed by the investigator using RECIST v1.1 or death, whichever occurs first.	Approximately 9 months
Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808		Approximately 1 month
Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808		Approximately 6 months
Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808	Pharmacokinetic analysis for BGB-26808 concentrations, alone or in combination with tislelizumab. Single-dose and steady-state PK parameters.	Approximately 1 month
Phase 1a: Half-life (t1/2) for BGB-26808		Approximately 1 month
Phase 1a: Apparent clearance (CL/F) for BGB-26808		Approximately 1 month
Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808		Approximately 1 month
Phase 1b: Number of Participants with AEs and SAEs	Number of participants with AEs and SAEs, including findings from physical examinations, 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: Area under the concentration-time curve (AUC) for BGB-26808		Approximately 2 months
Phase 1a: Accumulation ratio for BGB-26808		Approximately 2 months
Phase 1b: Plasma concentrations of BGB-26808		Approximately 2 months

Collaborators and Investigators

• Sponsor: BeOne Medicines
• Investigators: Study Director: Study Director, BeOne Medicines

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027

Study Registration Dates

• First Submitted: July 31, 2023
• First Submitted That Met QC Criteria: July 31, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): June 3, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: PD1; advanced solid tumor; Tislelizumab; HPK1; BGB-A317; BGB-26808
• Additional Relevant MeSH Terms: Neoplasms; Therapeutics; Drug Therapy; tislelizumab
• Other Study ID Numbers: BGB-A317-26808-101; CTR20240210 (Other Identifier: ChinaDrugTrials)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

BeOne shares data on completed studies responsibly and provides qualified scientific and medical researchers access to data and supporting documentation for clinical trials in dossiers for medicines and indications after submission and approval in the United States, China, and Europe. Clinical trials supporting subsequent local approvals, new indications, or combination products are eligible for sharing once corresponding regulatory approvals are achieved.

BeOne shares data only when permitted by applicable data privacy and security laws and regulations, when it is feasible to do so without compromising the privacy of study participants, and other considerations.

Qualified researchers with appropriate competencies who are engaged in novel scientific research may submit a request for participant-level data with a research proposal for BeOne review. Research teams must include a biostatistician and sign a Data Sharing Agreement prior to receiving access to clinical trial data.

• IPD Sharing Time Frame: See plan description
• IPD Sharing Access Criteria: See plan description
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No