Testing a new drug for advanced solid tumors and lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a first-in-human Phase 1 study evaluating the safety and tolerability of BPI-371153, a PD-L1 inhibitor, in patients with advanced solid tumors or relapsed/refractory lymphoma. The study aims to determine the maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) for further investigation. Participants will be enrolled based on specific eligibility criteria, including age and performance status, and will receive the investigational drug to assess its effects on their conditions.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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's running

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences
  Chaoyang, Beijing Municipality, China Recruiting
• Tianjin Cancer Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Tianjin Medical University General Hospital
  Tianjin, Tianjin Municipality, China Recruiting
• Cangzhou Central Hospital
  Cangzhou, Hebei, China Completed

Study contacts

• Principal investigator: Yuankai Shi, Ph.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Yuankai Shi, Ph.D
• Email: syuankaipumc@126.com
• Phone: 010-67781331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.