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

Non-small Cell Lung Cancer Clinical Trial

Official title:

A Phase 1/2 Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-361175 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329298
• Other study ID #: BTP-661411
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: July 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Caicun Zhou, Ph.D
• Phone: 021-65115006
• Email: fkzlkzhoudr[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Non-small Cell Lung Cancer

Intervention

Drug:
• BPI-361175
Subjects will receive BPI-361175 until disease progression

Locations

Country	Name	City	State
China	Hunan cancer hospital	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	the First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Jiangsu
China	Shanghai Pulmonary Hospital	Shanghai	Shanghai
China	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei
China	Henan Cancer Hospital	Zhengzhou	Henan

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	Phase I: 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	Phase I: Determine the recommended Phase II dose (RP2D)	Number of subjects with dose limiting toxicity	Through the Phase I, approximately 24 months
Primary	Phase II: the objective response rate (ORR)	The proportion of patients with complete response (CR) and partial response (PR) in all patients.	Through the Phase II, approximately 24 months
Secondary	Phase I: Evaluate the pharmacokinetics of BPI-361175	Blood plasma concentration	Through the Phase I, approximately 24 months
Secondary	Phase I: the objective response rate (ORR)	The proportion of patients with complete response (CR) and partial response (PR) in all patients.	Through the Phase I, approximately 24 months
Secondary	Phase II: Disease control rate (DCR)	The proportion of patients with CR, PR and stable disease (SD) in all patients.	Through the Phase II, approximately 24 months
Secondary	Phase II: Progression free survival (PFS)	The time from the first study dose to disease progression (PD) or death, whichever occurs first.	Through the Phase II, approximately 24 months
Secondary	Phase II: Overall survival (OS)	The time from the first study dose to death due to any cause.	Through the Phase II, approximately 24 months
Secondary	Phase II: Duration of response (DOR)	The time from the first CR or PR to the first PD or death due to any cause.	Through the Phase II, approximately 24 months
Secondary	Phase II: The adverse events (AEs)	Safety and tolerability will be assessed by monitoring frequency, duration and severity of adverse events (AEs).	Through the Phase II, approximately 24 months
Secondary	Phase I: Disease control rate (DCR)	The proportion of patients with CR, PR and stable disease (SD) in all patients.	Through the Phase I, approximately 24 months
Secondary	Phase I: Progression free survival (PFS)	The time from the first study dose to disease progression (PD) or death, whichever occurs first.	Through the Phase I, approximately 24 months
Secondary	Phase I: Overall survival (OS)	The time from the first study dose to death due to any cause.	Through the Phase I, approximately 24 months