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

ConditionsAdvanced Solid Tumor Lymphoma NSCLC HCC

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorBetta Pharmaceuticals Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Sequential

Treatments tested in this trial

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

Treatment groups

110 Participants

are divided into 2 treatment groups

Group A: Dose EscalationExperimental treatment 1 intervention

Group B: Dose ExpansionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

The adverse events (AEs)

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

Time frame