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A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

Primary Purpose

Metastasis, Neoplasm

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BPI-28592
Sponsored by
Betta Pharmaceuticals Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastasis, Neoplasm focused on measuring NTRK1/2/3, fusion

Eligibility Criteria

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

Inclusion Criteria:

  • Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor
  • At least 18 years of age
  • Measurable or evaluable disease
  • Adequate organ function as defined per protocol

Exclusion Criteria:

  • Symptomatic or unstable brain metastases
  • Pregnancy or lactation
  • Other protocol specified criteria

Sites / Locations

  • Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dose exploration and dose expansion

Arm Description

Patients receive BPI-28592 PO. Cycles repeat every 28 days.

Outcomes

Primary Outcome Measures

Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
Number of subjects with treatment related adverse events
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
Number of subjects with dose limiting toxicity

Secondary Outcome Measures

Evaluate the pharmacokinetics of BPI-28592
Blood plasma concentration
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592
Evaluate clinical activity/efficacy of BPI-28592
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Evaluate clinical activity/efficacy of BPI-28592
to evaluate the disease control rate (DCR)
Evaluate clinical activity/efficacy of BPI-28592
To evaluate progression-free survival (PFS) following initiation of BPI-28592
Evaluate clinical activity/efficacy of BPI-28592
To evaluate overall (OS) following initiation of BPI-28592
Evaluate clinical activity/efficacy of BPI-28592

Full Information

First Posted
March 10, 2022
Last Updated
March 21, 2022
Sponsor
Betta Pharmaceuticals Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05302843
Brief Title
A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors
Official Title
A Phase 1，Open-label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ascendind Doses of BPI-28592 in Subjects With Advanced Solid Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2021 (Actual)
Primary Completion Date
December 31, 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 an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastasis, Neoplasm
Keywords
NTRK1/2/3, fusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
dose exploration and dose expansion
Arm Type
Experimental
Arm Description
Patients receive BPI-28592 PO. Cycles repeat every 28 days.
Intervention Type
Drug
Intervention Name(s)
BPI-28592
Intervention Description
Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592
Primary Outcome Measure Information:
Title
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies
Description
Number of subjects with treatment related adverse events
Time Frame
about 20 months
Title
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen
Description
Number of subjects with dose limiting toxicity
Time Frame
about 20 months
Secondary Outcome Measure Information:
Title
Evaluate the pharmacokinetics of BPI-28592
Description
Blood plasma concentration
Time Frame
about 20 months
Title
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592
Description
Evaluate clinical activity/efficacy of BPI-28592
Time Frame
about 20 months
Title
To evaluate the duration of response (DOR) in subjects with CR or PR as best response
Description
Evaluate clinical activity/efficacy of BPI-28592
Time Frame
about 20 months
Title
to evaluate the disease control rate (DCR)
Description
Evaluate clinical activity/efficacy of BPI-28592
Time Frame
about 20 months
Title
To evaluate progression-free survival (PFS) following initiation of BPI-28592
Description
Evaluate clinical activity/efficacy of BPI-28592
Time Frame
about 20 months
Title
To evaluate overall (OS) following initiation of BPI-28592
Description
Evaluate clinical activity/efficacy of BPI-28592
Time Frame
about 20 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically- or cytologically-confirmed diagnosis of locally advanced or metastatic solid tumor At least 18 years of age Measurable or evaluable disease Adequate organ function as defined per protocol Exclusion Criteria: Symptomatic or unstable brain metastases Pregnancy or lactation Other protocol specified criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hongming Pan, Ph.D
Phone
0571-86006922
Email
shonco@sina.cn
Facility Information:
Facility Name
Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine
City
HangZhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongming Pan, Ph.D

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Study of BPI-28592 in Subjects With Advanced Solid Tumors

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