A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors

Phase 1

• Conditions: Non-small Cell Lung Cancer
• Interventions: Drug: BPI-361175

• Registration Number: NCT05329298
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief Summary

This is a phase I/II, open-label study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of BPI-361175 tablets in patients with advanced solid tumors including advanced Non-small cell Lung cancer (NSCLC).This is a three-stage study, consisting of Phase Ia dose escalation, Phase Ib dose expansion and pivotal Phase II Study. The pivotal Phase II study will be designed based on data generated from the Phase I studies.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-21
• Status Verified: 2022-03
• Study First Submitted: 2022-03-31
• Study First Submitted QC: 2022-04-07
• Last Update Submitted: 2022-04-07
• Study First Posted: 2022-04-15
• Last Update Posted: 2022-04-15
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Male or female ≥ 18 years old;
• Patients with histologically or cytologically confirmed diagnosis of inoperable locally advanced or recurrent/metastatic non-small cell lung cancer (NSCLC) with EGFR sensitive mutations. Patients must have progressed from or be intolerant to or be unfit for standard treatment, or the standard treatment does not exist;
• For dose expansion and Phase II, patients must be willing to provide tumor tissues (archived tumor tissue samples within 2 years or fresh tumor tissues) and/or blood samples for central lab testing;
• Measurable or evaluable disease;
• Adequate bone marrow, liver, and renal function.

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Exclusion Criteria

• Unstable, symptomatic primary CNS tumors/metastasis or leptomeningeal metastases which are not suitable for enrollment, as judged by investigators;
• Pregnancy or lactation;
• Other protocol specified criteria.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase II	BPI-361175	Patients receive BPI-361175 based on RP2D.
Phase I	BPI-361175	Patients will receive a single dose on Day 1, then after an 7-day wash-out period, repeated dosing, once daily will be initiated(Ia). Patients receive BPI-361175 PO. Cycles repeat every 28 days(Ib).

Primary Outcome Measures

Name	Time	Method
Phase II: the objective response rate (ORR)	Through the Phase II, approximately 24 months	The proportion of patients with complete response (CR) and partial response (PR) in all patients.
Phase I: The adverse events (AEs)	Through the Phase I, approximately 24 months	Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Phase I: Determine the recommended Phase II dose (RP2D)	Through the Phase I, approximately 24 months	Number of subjects with dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Phase II: Progression free survival (PFS)	Through the Phase II, approximately 24 months	The time from the first study dose to disease progression (PD) or death, whichever occurs first.
Phase II: Duration of response (DOR)	Through the Phase II, approximately 24 months	The time from the first CR or PR to the first PD or death due to any cause.
Phase I: Evaluate the pharmacokinetics of BPI-361175	Through the Phase I, approximately 24 months	Blood plasma concentration
Phase II: Overall survival (OS)	Through the Phase II, approximately 24 months	The time from the first study dose to death due to any cause.
Phase I: the objective response rate (ORR)	Through the Phase I, approximately 24 months	The proportion of patients with complete response (CR) and partial response (PR) in all patients.
Phase II: Disease control rate (DCR)	Through the Phase II, approximately 24 months	The proportion of patients with CR, PR and stable disease (SD) in all patients.
Phase I: Overall survival (OS)	Through the Phase I, approximately 24 months	The time from the first study dose to death due to any cause.
Phase II: The adverse events (AEs)	Through the Phase II, approximately 24 months	Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).
Phase I: Disease control rate (DCR)	Through the Phase I, approximately 24 months	The proportion of patients with CR, PR and stable disease (SD) in all patients.
Phase I: Progression free survival (PFS)	Through the Phase I, approximately 24 months	The time from the first study dose to disease progression (PD) or death, whichever occurs first.

Trial Locations

Locations (8)

Jiangsu Cancer Hospital; 🇨🇳 Nanjing, Jiangsu, China

Shanghai Pulmonary Hospital; 🇨🇳 Shanghai, Shanghai, China

Xiangya Hospital of Central South University; 🇨🇳 Changsha, Hunan, China

Henan Cancer Hospital; 🇨🇳 Zhengzhou, Henan, China

Hunan cancer hospital; 🇨🇳 Changsha, Hunan, China

Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

the First Affiliated Hospital, College of Medicine, Zhejiang University; 🇨🇳 Hangzhou, Zhejiang, China