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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05329298

Collaborator

(none)

Enrollment

Locations

Arms

29.3

Anticipated Duration (Months)

11.3

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Drug: BPI-361175	Phase 1/Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Non-Randomized

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 21, 2021

Anticipated Primary Completion Date :

Jun 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Phase I 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).	Drug: BPI-361175 Subjects will receive BPI-361175 until disease progression
Experimental: Phase II Patients receive BPI-361175 based on RP2D.	Drug: BPI-361175 Subjects will receive BPI-361175 until disease progression

Arm

Intervention/Treatment

Experimental: Phase I

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).

Drug: BPI-361175

Subjects will receive BPI-361175 until disease progression

Experimental: Phase II

Patients receive BPI-361175 based on RP2D.

Drug: BPI-361175

Subjects will receive BPI-361175 until disease progression

Outcome Measures

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Phase I: Evaluate the pharmacokinetics of BPI-361175 [Through the Phase I, approximately 24 months]
Blood plasma concentration
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 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: Overall survival (OS) [Through the Phase II, approximately 24 months]
The time from the first study dose to death due to any cause.
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 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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Henan Cancer Hospital	Zhengzhou	Henan	China	450008
2	Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology	Wuhan	Hubei	China	430030
3	Xiangya Hospital of Central South University	Changsha	Hunan	China	410011
4	Hunan cancer hospital	Changsha	Hunan	China	410013
5	Jiangsu Cancer Hospital	Nanjing	Jiangsu	China	210009
6	Jiangsu Province Hospital	Nanjing	Jiangsu	China	210029
7	Shanghai Pulmonary Hospital	Shanghai	Shanghai	China	200433
8	the First Affiliated Hospital, College of Medicine, Zhejiang University	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

Betta Pharmaceuticals Co., Ltd.

Investigators

Principal Investigator: Caicun Zhou, Ph.D, Shanghai Pulmonary Hospital, Shanghai, China
Principal Investigator: Jianying Zhou, Ph.D, First Affiliated Hospital of Zhejiang University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Betta Pharmaceuticals Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05329298

Other Study ID Numbers:

BTP-661411

First Posted:

Apr 15, 2022

Last Update Posted:

Apr 15, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Carcinoma, Non-Small-Cell Lung

Study Results

No Results Posted as of Apr 15, 2022