A Phase 1，Open-label Study of BPI-421286 in Subjects With Advanced Solid Tumors

Metastatic Cancer Clinical Trial

Official title:

A Phase 1，Open-label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of BPI-421286 in Subjects With Advanced Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05315180
• Other study ID #: BTP-661311
• Status: Recruiting
• Phase: Phase 1
• Start date: August 24, 2021
• Est. completion date: July 31, 2023

Study information

• Verified date: February 2022
• Source: Betta Pharmaceuticals Co., Ltd.
• Contact: Shun Lu, Ph.D
• Phone: 13601813062
• Email: shun_lu[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the safety and tolerability of BPI-421286 in adult subjects with advanced solid tumors.

Estimate the maximum tolerated dose (MTD) and/or a recommended phase 2 dose (RP2D) in adult subjects with advanced solid tumors.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Pathologically documented, locally-advanced or metastatic malignancy

• Standard treatment is not available or patient declines

• Adequate organ function

Exclusion Criteria:

• Active brain metastases from non-brain tumors.

• Gastrointestinal (GI) tract disease causing the inability to take oral medication.

• Other protocol specified criteria

Related Conditions & MeSH terms

• Malignant Neoplasms
• Metastatic Cancer
• Neoplasms

Intervention

Drug:
• BPI-421286
Characterize the pharmacokinetics (PK),safety,effcicay of BPI-421286 following administration as an oral Tablet formulation

Locations

Country	Name	City	State
China	Wen Li, Ph.D	Hangzhou	Zhejiang
China	Yun Fan,Ph.D	Hangzhou	Zhejiang
China	Shun Lu, Ph.D	Shanghai
China	Shun Lu, Ph.D	Shanghai	Shanghai
China	Dingzhi Huang, Ph.D	Tianjin	Tianjin

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-421286 in subjects with advanced solid tumor malignancies	Number of subjects with treatment related adverse events	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	20 months
Secondary	Evaluate the pharmacokinetics of BPI-421286	Blood plasma concentration	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-421286	Evaluate clinical activity/efficacy of BPI-421286	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-421286	20 months
Secondary	to evaluate the disease control rate (DCR)	Evaluate clinical activity/efficacy of BPI-421286	20 months
Secondary	To evaluate progression-free survival (PFS) following initiation of BPI-421286	Evaluate clinical activity/efficacy of BPI-421286	20 months
Secondary	To evaluate overall (OS) following initiation of BPI-421286	Evaluate clinical activity/efficacy of BPI-421286	20 months