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

Metastasis, Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05302843
• Other study ID #: BTP-661211
• Status: Recruiting
• Phase: Phase 1
• Start date: March 22, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Hongming Pan, Ph.D
• Phone: 0571-86006922
• Email: shonco[@]sina.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-labe Phase I study of BPI-28592 for the treatment of patients with solid tumors

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metastasis, Neoplasm
• Neoplasm Metastasis

Intervention

Drug:
• BPI-28592
Characterize the pharmacokinetics (PK),safety,antitumor activity of BPI-28592

Locations

Country	Name	City	State
China	Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine	HangZhou	Zhejiang

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	Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies	Number of subjects with treatment related adverse events	about 20 months
Primary	determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen	Number of subjects with dose limiting toxicity	about 20 months
Secondary	Evaluate the pharmacokinetics of BPI-28592	Blood plasma concentration	about 20 months
Secondary	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	about 20 months
Secondary	To evaluate the duration of response (DOR) in subjects with CR or PR as best response	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
Secondary	to evaluate the disease control rate (DCR)	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
Secondary	To evaluate progression-free survival (PFS) following initiation of BPI-28592	Evaluate clinical activity/efficacy of BPI-28592	about 20 months
Secondary	To evaluate overall (OS) following initiation of BPI-28592	Evaluate clinical activity/efficacy of BPI-28592	about 20 months