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

Official title

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

Overview

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.

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.

Interventions

• Drug BGB-26808
  Planned doses administered orally as a tablet daily.
• Drug Tislelizumab
  Planned doses administered by intravenous infusion.
• Drug Chemotherapy
  Administered in accordance with relevant local guidelines and/or prescribing information.

Primary outcome measures

• 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]

Secondary outcome measures (12)

• Phase 1a: ORR [Time frame: Approximately 6 months]
• Phase 1a and 1b: Duration of Response (DOR) [Time frame: Approximately 9 months]
• Phase 1a and 1b: Disease Control Rate (DCR) [Time frame: Approximately 6 months]
• Phase 1a and 1b: Clinical Benefit Rate (CBR) [Time frame: Approximately 6 months]
• Phase 1b: Progression Free Survival (PFS) [Time frame: Approximately 9 months]
• Phase 1a: Maximum observed plasma concentration (Cmax) for BGB-26808 [Time frame: Approximately 1 month]
• Phase 1a: Minimum observed plasma concentration (Cmin) for BGB-26808 [Time frame: Approximately 6 months]
• Phase 1a: Time to maximum plasma concentration (Tmax) for BGB-26808 [Time frame: Approximately 1 month]
• Phase 1a: Half-life (t1/2) for BGB-26808 [Time frame: Approximately 1 month]
• Phase 1a: Area under the concentration-time curve (AUC) for BGB-26808 [Time frame: Approximately 2 months]
• Phase 1a: Apparent clearance (CL/F) for BGB-26808 [Time frame: Approximately 1 month]
• Phase 1a: Apparent volume of distribution (Vz/F) for BGB-26808 [Time frame: Approximately 1 month]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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).

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Sequential

Masking

Open label

Primary purpose

Treatment

Study locations

China · 12 centers

• The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch — Hefei
• Harbin Medical University Cancer Hospital — Harbin
• Hubei Cancer Hospital — Wuhan
• Tongji Hospital,Tongji Medical College of Hustsino French New City Branch — Wuhan
• The First Hospital of China Medical University Hunnan Branch — Shenyang
• Jining No1 Peoples Hospital West Branch — Jining
• Yantai Yuhuangding Hospital — Yantai
• Shanghai East Hospital Branch Hospital — Shanghai
• … and 4 more centers

United States · 9 centers

• City of Hope National Medical Center — Duarte
• University of Southern California Norris Comprehensive — Los Angeles
• Yale University Yale Cancer Center — New Haven
• Sylvester Cancer Center, University of Miami — Miami
• University of Michigan Health System — Ann Arbor
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack
• Icahn School of Medicine At Mount Sinai — New York
• Providence Portland Medical Center — Portland
• … and 1 more center

Australia · 4 centers

• Southside Cancer Care — Miranda
• Macquarie University — North Ryde
• Icon Cancer Centre Kurralta Park — Kurralta Park
• Linear Clinical Research — Nedlands

New Zealand · 3 centers

• Auckland City Hospital — Auckland
• Harbour Cancer and Wellness — Auckland
• Health New Zealand Te Whatu Ora Lakes Rotorua Hospital — Rotorua

Identifiers

NCT: NCT05981703 · BGB-A317-26808-101 · CTR20240210

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)
• NMPA/CDE CTR20240210 (chinadrugtrials.org.cn platform)

View this study on ClinicalTrials.gov ↗