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

Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05341557
• Other study ID #: BTP-661611
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: June 2022
• Est. completion date: June 1, 2025

Study information

• Verified date: April 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Yuankai Shi, Ph.D
• Phone: 010-67781331
• Email: syuankaipumc[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 110
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Solid Tumor
• HCC
• Lymphoma
• NSCLC

Intervention

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

Locations

Country	Name	City	State
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Chaoyang	Beijing
China	Tianjin Cancer Hospital	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Betta Pharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Determine the recommended Phase II dose (RP2D)	Number of subjects with dose limiting toxicity	Through the Phase I, approximately 24 months
Secondary	Evaluate the pharmacokinetics of BPI-371153	Based on blood plasma concentration	Through the Phase I, approximately 24 months
Secondary	Determination of anti-tumor activity of BPI-371153	Efficacy assessments (tumor evaluation) will be performed per RECIST1.1, mRECIST or Lugano 2014 depending on tumor type.	Through the Phase I, approximately 24 months
Secondary	To explore the levels of expression of PD-L1 associated with BPI-371153 clinical activity	Based on the levels of expression of PD-L1 and anti-tumor activity of BPI-371153	Through the Phase I, approximately 24 months