A Phase 1 Study of BPI-371153 in Subjects with Advanced Solid Tumors or Relapsed/Refractory Lymphoma

Recruiting now · Phase 1

Conditions studied: Advanced Solid Tumor, Lymphoma, NSCLC, HCC

In brief

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.

Key facts

Study ID

NCT05341557

Run by

Betta Pharmaceuticals Co., Ltd.

People needed

110

Starts

2022-08-29

Expected to finish

2027-04-01

Last updated by the study team

2025-01-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dose escalation phase: Age ≥18 and ≤65 years, male and female patients; Dose expansion phase: Age ≥18, male and female patients;
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1;
• Dose escalation phase: histologically or cytologically confirmed locally advanced or metastatic solid tumor patients (excluding HCC patients) or relapsed/refractory lymphoma, who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Dose expansion phase: histologically or cytologically confirmed locally advanced or relapsed/metastatic Non-Driver Mutation NSCLC, relapsed/refractory lymphoma, HCC with Child-Pugh A or B(≤ 7 points), or other diagnosed solid tumor patients who had disease progression after standard therapy, intolerable to standard therapy, refuse to standard therapy or for whom no standard therapy exists;
• Evaluable lesion required for dose escalation phase and at least 1 measurable lesion as per RECIST v1.1( for other diagnosed solid tumos excluding HCC), mRECIST(for HCC) or Lugano 2014(for lymphoma);
• Adequate organ function;

You may not qualify if…

• Dose escalation phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy;
• Dose expansion phase: Prior immune checkpoint inhibition with anti-programmed cell death-1 (PD1)/programmed death ligand-1(PD-L1) or programmed death ligand-2(PD-L2) therapy within 28 days prior to treatment. Subjects with a history of a Grade 3 or higher immune-related AE from prior immunotherapies;
• Prior other specific T cell targeting agents;
• Use of systemic or absorbable topical corticosteroids therapy(≥ 10 mg/day prednisone or equivalent) two weeks prior to start of treatment.
• Inadequate wash-out of prior therapies described per protocol, which may include anti-tumor therapies, tumor adjuvant drugs, organ or stem cell transplantation, moderate or strong CYP3A inhibitor or inducer, and vaccine;
• Patients with major surgery within 4 weeks, severe or unstable systemic disease, unstable/symptomatic CNS metastasis, other malignant tumors, autoimmune disease, ILD, clinical significant cardiac disease, bleeding or embolic disease, active infectious disease, conditions affecting drug swallow and absorption, medical history leading to chronic diarrhea, etc;
• Pregnancy or lactation;
• Other conditions considered not appropriate to participate in this trial by the investigators.

Where it is running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Chaoyang, Beijing Municipality, China (enrolling)
• Tianjin Cancer Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• Cangzhou Central Hospital — Cangzhou, Hebei, China

Full record on ClinicalTrials.gov

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