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Recruiting NCT05341557

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

Phase I Interventional Advanced Solid Tumor Lymphoma NSCLC HCC

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BPI-371153.
Who it may be relevant to
Registry conditions: Advanced Solid Tumor, Lymphoma, NSCLC, HCC. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug BPI-371153
    Subjects will receive BPI-371153 until disease progression

Primary outcome measures

  • The adverse events (AEs) [Time frame: Through the Phase I, approximately 24 months]
  • Determine the recommended Phase II dose (RP2D) [Time frame: Through the Phase I, approximately 24 months]
Secondary outcome measures (3)
  • Evaluate the pharmacokinetics of BPI-371153 [Time frame: Through the Phase I, approximately 24 months]
  • Determination of anti-tumor activity of BPI-371153 [Time frame: Through the Phase I, approximately 24 months]
  • To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity [Time frame: Through the Phase I, approximately 24 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

China · 4 centers
  • Cancer Institute and Hospital, Chinese Academy of Medical Sciences — Chaoyang
  • Cangzhou Central Hospital — Cangzhou
  • Tianjin Cancer Hospital — Tianjin
  • Tianjin Medical University General Hospital — Tianjin

Identifiers

NCT: NCT05341557 · BTP-661611

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗