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

Primary Purpose

Non-small Cell Lung Cancer

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BPI-361175
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Henan Cancer HospitalRecruiting
  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and TechnologyRecruiting
  • Xiangya Hospital of Central South UniversityRecruiting
  • Hunan cancer hospitalRecruiting
  • Jiangsu Cancer HospitalRecruiting
  • Jiangsu Province HospitalRecruiting
  • Shanghai Pulmonary HospitalRecruiting
  • the First Affiliated Hospital, College of Medicine, Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Phase I

Phase II

Arm Description

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).

Patients receive BPI-361175 based on RP2D.

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
March 31, 2022
Last Updated
April 7, 2022
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05329298
Brief Title
A Phase 1/2 Study of BPI-361175 in Subjects With Advanced Solid Tumors
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2021 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Betta Pharmaceuticals Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caicun Zhou, Ph.D
Phone
021-65115006
Email
fkzlkzhoudr@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jianying Zhou, Ph.D
Phone
0571-87236114
Email
drzjy@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Ph.D
Organizational Affiliation
Shanghai Pulmonary Hospital, Shanghai, China
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, Ph.D
Organizational Affiliation
First Affiliated Hospital of Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henan Cancer Hospital
City
Zhengzhou
State/Province
Henan
ZIP/Postal Code
450008
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qiming Wang, Ph.D
Facility Name
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qian Chu, Ph.D
Email
qianchu@163.com
Facility Name
Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengping Hu, Ph.D
Phone
0731-89753733
Email
664990095@qq.com
Facility Name
Hunan cancer hospital
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410013
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nong Yang, Ph.D
Facility Name
Jiangsu Cancer Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210009
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meiqi Shi, Ph.D
Phone
0731-88651322
Email
yangnongpi@163.com
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yongqian Shu, Ph.D
Phone
025-83714511
Facility Name
Shanghai Pulmonary Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Ph.D
Phone
021-65115006
Email
fkzlkzhoudr@126.com
First Name & Middle Initial & Last Name & Degree
Caicun Zhou, Ph.D
Facility Name
the First Affiliated Hospital, College of Medicine, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310003
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jianying Zhou, Ph.D
Phone
0571-87236114
Email
drzjy@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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