BGB-A317-26808-101
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
Trial 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.
Receptor status / problem studied:
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) Participants with histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors that are immune-sensitive who have been previously treated.
4) ≥ 1 measurable lesion per RECIST v1.1.
5) Able to provide an archived tumor tissue sample.
6) Adequate organ function.
7) 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.
8) 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.
Exclusion criteria
1) Uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention.
2) Clinically significant bleeding from the gastrointestinal tract within 28 days before the first dose of study treatment(s).
3) Active leptomeningeal disease or uncontrolled, untreated brain metastasis.
4) Active autoimmune diseases or history of autoimmune diseases that may relapse.
5) 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).
6) 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).
7) History of interstitial lung disease, noninfectious pneumonitis, or uncontrolled lung diseases including pulmonary fibrosis, acute lung diseases.
8) Uncontrolled diabetes.
9) Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Trial Title
BGB-A317-26808-101
Diagnosis
Advanced solid tumours
Type of trial
Pharmaceutical
Type of treatement
Medical Oncology
Phase
Ia/b