Actively Recruiting
A Phase 1 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Led by Betta Pharmaceuticals Co., Ltd. · Updated on 2025-01-27
110
Participants Needed
4
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and maximum tolerated dose of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma. This phase 1 open-label study aims to establish the recommended dose for further research and to understand how the drug behaves in the body and its anti-tumor activity. Participants will receive oral capsules of BPI-371153 once daily in 21-day treatment cycles. The study includes a dose escalation phase to find the maximum tolerated dose and a dose expansion phase where patients receive the recommended dose. Different patient groups include those with advanced non-small cell lung cancer, relapsed or refractory lymphoma, hepatocellular carcinoma, and other advanced solid tumors. During the study, participants will be monitored for adverse events, drug levels in the body, and tumor response over approximately 24 months. Researchers will assess tumor lesions using recognized criteria and evaluate PD-L1 expression levels. The study requires adequate organ function and performance status, with ongoing evaluation to ensure safety and determine the best dose for future studies.
CONDITIONS
Brief Title
A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Histologically or cytologically confirmed advanced or metastatic solid tumors (excluding HCC) or relapsed/refractory lymphoma with disease progression after or intolerance to standard therapy
- For dose expansion: confirmed advanced or metastatic non-driver mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B (≤7 points), or other solid tumors with disease progression after or intolerance to standard therapy
- At least one measurable lesion per RECIST v1.1, mRECIST, or Lugano 2014 criteria
- Adequate organ function
You will not qualify if you...
- Prior immune checkpoint inhibition therapy with anti-PD1, PD-L1, or PD-L2 (dose escalation phase) or within 28 days before treatment (dose expansion phase)
- History of Grade 3 or higher immune-related adverse events from prior immunotherapies
- Prior use of other specific T cell targeting agents
- Use of systemic or absorbable topical corticosteroids (≥10 mg/day prednisone or equivalent) within two weeks before treatment
- Inadequate wash-out periods for prior therapies including anti-tumor treatments, transplantation, CYP3A inhibitors/inducers, and vaccines
- Major surgery within 4 weeks prior to study entry
- Severe or unstable systemic disease, symptomatic CNS metastasis, other malignancies, autoimmune diseases, interstitial lung disease, significant cardiac disease, bleeding or embolic disorders, active infections, or conditions affecting drug swallowing or absorption
- Pregnancy or lactation
- Any other condition deemed inappropriate for participation by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive oral capsules of BPI-371153 once daily in 21-day cycles until disease progression.
Visits occur at the start of each 21-day treatment cycle
Trial Site Locations
Total: 4 locations
1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Chaoyang, Beijing Municipality, China, 100021
Actively Recruiting
2
Cangzhou Central Hospital
Cangzhou, Hebei, China, 062650
Completed
3
Tianjin Cancer Hospital
Tianjin, Tianjin Municipality, China, 300060
Actively Recruiting
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300070
Actively Recruiting
Research Team
Y
Yuankai Shi, Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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