Actively Recruiting
Phase 1 Study to Evaluate Safety, Dose, and Effects of BPI-371153, a PD-L1 Inhibitor, in Patients 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
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety, tolerability, and appropriate dosing of BPI-371153, a PD-L1 inhibitor, in adults with advanced solid tumors or relapsed/refractory lymphoma. The study focuses on patients who have progressed after or cannot tolerate standard therapies, including specific cancers like non-driver mutation NSCLC, hepatocellular carcinoma (HCC), and lymphoma. It is a Phase 1 open-label trial designed to find the maximum tolerated dose and recommend a dose for future studies. Participants will receive BPI-371153 continuously until their disease progresses. The study includes a dose escalation phase for adults aged 18 to 65 years and a dose expansion phase open to adults 18 years and older. Patients must have measurable or evaluable lesions depending on their cancer type, and adequate organ function is required. The trial excludes those who have received prior immune checkpoint inhibitors or certain other therapies recently or have specific health conditions. Throughout approximately 24 months, researchers will monitor adverse events and determine the recommended Phase 2 dose. Patients will undergo evaluations including imaging based on RECIST, mRECIST, or Lugano 2014 criteria as appropriate. Safety, pharmacokinetics, and efficacy will be assessed, with careful monitoring for immune-related side effects. Participation duration depends on disease progression and treatment tolerance.
CONDITIONS
Official 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...
- For dose escalation phase: age 18 to 65 years, male or female
- For dose expansion phase: age 18 years or older, male or female
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- For dose escalation phase: confirmed advanced or metastatic solid tumor (excluding HCC) or relapsed/refractory lymphoma with disease progression after or intolerance to standard therapy
- For dose expansion phase: confirmed 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 evaluable lesion for dose escalation phase and one measurable lesion per RECIST v1.1 (solid tumors excluding HCC), mRECIST (HCC), or Lugano 2014 (lymphoma)
- Adequate organ function
You will not qualify if you...
- For dose escalation phase: prior treatment with PD-1, PD-L1, or PD-L2 immune checkpoint inhibitors
- For dose expansion phase: prior treatment with PD-1, PD-L1, or PD-L2 immune checkpoint inhibitors within 28 days before treatment or history of grade 3 or higher immune-related adverse events from immunotherapy
- Prior treatment with 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 washout from prior therapies including anti-tumor drugs, transplantation, CYP3A modulators, and vaccines
- Major surgery within 4 weeks before study
- Severe, unstable systemic diseases or unstable/symptomatic CNS metastases
- Presence of other malignant tumors, autoimmune disease, interstitial lung disease, significant cardiac disease, bleeding or embolic disorders, active infections, or conditions affecting drug swallowing or absorption
- History leading to chronic diarrhea
- Pregnancy or lactation
- Other conditions judged inappropriate for participation by investigators
AI-Screening
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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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