Testing a new drug for advanced solid tumors and 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

This study is testing a new drug called BPI-371153 to see if it is safe and effective for people with advanced solid tumors or lymphoma that hasn’t responded to other treatments.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Betta Pharmaceuticals Co., Ltd. (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 4 sites (Chaoyang, Beijing Municipality and 3 other locations)
• Trial ID: NCT05341557 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 with advanced solid tumors or relapsed/refractory lymphoma who have experienced disease progression after standard therapies.

Not a fit: Patients with early-stage tumors or those who have not yet undergone standard therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with advanced solid tumors and lymphoma who have limited or no effective therapies available.

How similar studies have performed: Other studies involving PD-L1 inhibitors have shown promising results, indicating potential for success with this novel approach.

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.

Where this trial is running

Chaoyang, Beijing Municipality and 3 other locations

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

Study contacts

• Principal investigator: Yuankai Shi, Ph.D — Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Study coordinator: Yuankai Shi, Ph.D

Conditions Advanced Solid Tumor; Lymphoma; NSCLC; HCC