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

April 7, 2022 updated by: Betta Pharmaceuticals Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jianying Zhou, Ph.D
  • Phone Number: 0571-87236114
  • Email: drzjy@163.com

Study Locations

  • China
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Qiming Wang, Ph.D
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital
        • Contact:
          • Nong Yang, Ph.D
      • Changsha, Hunan, China, 410011
        • Recruiting
        • Xiangya Hospital of Central South University
        • Contact:
    • Jiangsu
      • Nanjing, Jiangsu, China, 210009
        • Recruiting
        • Jiangsu Cancer Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Yongqian Shu, Ph.D
          • Phone Number: 025-83714511
    • Shanghai
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Shanghai Pulmonary Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, College of Medicine, Zhejiang University
        • Contact:
          • Jianying Zhou, Ph.D
          • Phone Number: 0571-87236114
          • Email: drzjy@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SEQUENTIAL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 21, 2021

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

March 31, 2022

First Submitted That Met QC Criteria

April 7, 2022

First Posted (ACTUAL)

April 15, 2022

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 7, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BTP-661411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Non-small Cell Lung Cancer

Clinical Trials on BPI-361175

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe