RecruitingPhase 1NCT05341557

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

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

Sponsor

Betta Pharmaceuticals Co., Ltd.

Enrollment

110 participants

Start Date

Aug 29, 2022

Study Type

INTERVENTIONAL

Conditions

Advanced Solid Tumor NSCLC Lymphoma HCC

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a Phase 1 study testing a new cancer drug called BPI-371153 to find the safest dose and see initial signs of effectiveness in patients with advanced solid tumors or lymphoma that has come back after standard treatments. **You may be eligible if...** - You are 18 years or older (up to 65 for the dose-escalation phase) - You have a confirmed advanced solid tumor or relapsed/refractory lymphoma - Your cancer has progressed after standard treatment, or you cannot tolerate standard therapy - Your ECOG performance status is 0 or 1 - Your organ function meets required criteria **You may NOT be eligible if...** - You are in poor general health (ECOG status above 1) - You have had certain prior treatments that exclude participation - Your organ function (liver, kidneys, heart) does not meet required levels - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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