Actively Recruiting
A Phase 1 Study 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
239 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-371153, a PD-L1 Inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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