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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05341557
Other study ID # BTP-661611
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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