Investigating BGB-26808 alone or with Tislelizumab for 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 study is testing a new treatment called BGB-26808, both by itself and with another drug called Tislelizumab, to see how well it works and what the best dose is for people with advanced solid tumors.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 217 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: BeOne Medicines (Industry-sponsored)
• Drugs / interventions: tislelizumab, chemotherapy, prednisone
• Locations: 27 sites (Duarte, California and 26 other locations)
• Trial ID: NCT05981703 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter, nonrandomized study evaluates the safety and efficacy of BGB-26808, both as a standalone treatment and in combination with Tislelizumab, in patients with advanced solid tumors. The study aims to determine the recommended dosing for BGB-26808 through a dose escalation and expansion approach. Participants will be monitored for their response to the treatment and any associated side effects.

Who should consider this trial

Good fit: Ideal candidates include individuals with advanced, unresectable solid tumors who have previously received standard systemic therapy or for whom such treatment is not appropriate.

Not a fit: Patients with early-stage solid tumors or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors who have limited therapeutic alternatives.

How similar studies have performed: Other studies have shown promise with similar immunotherapy approaches, suggesting potential for success in this novel combination.

Eligibility criteria

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.

Where this trial is running

Duarte, California and 26 other locations

• City of Hope National Medical Center — Duarte, California, United States (Recruiting)
• University of Southern California Norris Comprehensive — Los Angeles, California, United States (Recruiting)
• Yale University, Yale Cancer Center — New Haven, Connecticut, United States (Recruiting)
• Sylvester Cancer Center, University of Miami — Miami, Florida, United States (Recruiting)
• John Theurer Cancer Center Hackensack University Medical Center — Hackensack, New Jersey, United States (Recruiting)
• Icahn School of Medicine At Mount Sinai — New York, New York, United States (Recruiting)
• Providence Portland Medical Center — Portland, Oregon, United States (Recruiting)
• The University of Texas Md Anderson Cancer Center — Houston, Texas, United States (Recruiting)
• Southside Cancer Care — Miranda, New South Wales, Australia (Completed)
• Macquarie University — North Ryde, New South Wales, Australia (Recruiting)
• Icon Cancer Centre Kurralta Park — Kurralta Park, South Australia, Australia (Recruiting)
• Linear Clinical Research — Nedlands, Western Australia, Australia (Recruiting)
• The First Affiliated Hospital of Anhui Medical Universitygaoxin Branch — Hefei, Anhui, China (Recruiting)
• Harbin Medical University Cancer Hospital — Harbin, Heilongjiang, China (Recruiting)
• Hubei Cancer Hospital — Wuhan, Hubei, China (Recruiting)
• Tongji Hospital,Tongji Medical College of Hustsino French New City Branch — Wuhan, Hubei, China (Recruiting)
• The First Hospital of China Medical University Hunnan Branch — Shenyang, Liaoning, China (Recruiting)
• Jining No1 Peoples Hospital West Branch — Jining, Shandong, China (Recruiting)
• Yantai Yuhuangding Hospital — Yantai, Shandong, China (Recruiting)
• Shanghai East Hospital Branch Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
• Shanghai Pulmonary Hospital — Shanghai, Shanghai Municipality, China (Completed)
• Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital — Chengdu, Sichuan, China (Recruiting)
• Hangzhou First Peoples Hospital — Hangzhou, Zhejiang, China (Recruiting)
• Taizhou Hospital of Zhejiang Province (East) — Taizhou, Zhejiang, China (Completed)
• Auckland City Hospital — Auckland, New Zealand (Recruiting)
• Harbour Cancer and Wellness — Auckland, New Zealand (Recruiting)
• Health New Zealand Te Whatu Ora Lakes Rotorua Hospital — Rotorua, New Zealand (Recruiting)

Study contacts

• Study coordinator: Study Director

Conditions Advanced Solid Tumor; Solid Tumor; advanced solid tumor; BGB-26808; BGB-A317; Tislelizumab; PD1; HPK1