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

NCT05341557 | Recruiting Phase 1

• 1 other identifier: BTP-661611
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 4

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.

Conditions

Advanced Solid Tumor; Lymphoma; NSCLC; HCC

Outcome Measures

Primary Outcomes (2)

• The adverse events (AEs)

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

  Through the Phase I, approximately 24 months

• Determine the recommended Phase II dose (RP2D)

  Number of subjects with dose limiting toxicity

  Through the Phase I, approximately 24 months

Secondary Outcomes (3)

• Evaluate the pharmacokinetics of BPI-371153

  Through the Phase I, approximately 24 months

• 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

Study Arms (2)

Dose Escalation

EXPERIMENTAL

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).

Drug: BPI-371153

Dose Expansion

EXPERIMENTAL

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

Drug: BPI-371153

Interventions

BPI-371153 DRUG

Subjects will receive BPI-371153 until disease progression

Dose Escalation; Dose Expansion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Betta Pharmaceuticals Co., Ltd.: lead

Study Sites (4)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Chaoyang, Beijing Municipality, 100021, China

RECRUITING

Cangzhou Central Hospital

Cangzhou, Hebei, 062650, China

COMPLETED

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300070, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Yuankai Shi, Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuankai Shi, Ph.D

CONTACT

010-67781331; syuankaipumc@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2022
• First Posted: April 22, 2022
• Study Start: August 29, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)