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

Betta Pharmaceuticals Co., Ltd.4 sites in 1 country110 target enrollmentAugust 29, 2022

ConditionsAdvanced Solid Tumor Lymphoma NSCLC HCC

InterventionsBPI-371153

DrugsBPI-371153

Overview

Phase: Phase 1
Intervention: BPI-371153
Conditions: Advanced Solid Tumor
Sponsor: Betta Pharmaceuticals Co., Ltd.
Enrollment: 110
Locations: 4
Primary Endpoint: Determine the recommended Phase II dose (RP2D)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

August 29, 2022

End Date

April 2027

Last Updated

last year

Study Type

Interventional

Study Design

Sequential

Sex

All

Investigators

Sponsor

Betta Pharmaceuticals Co., Ltd.

Responsible Party

Sponsor

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.

Arms & Interventions

Dose Escalation

Oral capsules taken in escalating levels to determine MTD/RP2D. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD).

Intervention: BPI-371153

Dose Expansion

Oral capsules administered at recommended doses. Each treatment cycle will be 21 days in duration with BPI-371153 administered, once daily (QD). Cohort 1: Advanced NSCLC Cohort 2: Relapsed/refractory lymphoma Cohort 3: Advanced HCC Cohort 4: Other Advanced Solid Tumors

Intervention: BPI-371153

Outcomes

Primary Outcomes

Determine the recommended Phase II dose (RP2D)

Time Frame: Through the Phase I, approximately 24 months

Number of subjects with dose limiting toxicity

The adverse events (AEs)

Time Frame: Through the Phase I, approximately 24 months

Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs)

Secondary Outcomes

Determination of anti-tumor activity of BPI-371153(Through the Phase I, approximately 24 months)
To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity(Through the Phase I, approximately 24 months)
Evaluate the pharmacokinetics of BPI-371153(Through the Phase I, approximately 24 months)