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

Phase 1

• Conditions: Malignant Neoplasms; Metastatic Cancer
• Interventions: Drug: BPI-421286

• Registration Number: NCT05315180
• Lead Sponsor: Betta Pharmaceuticals Co., Ltd.

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-08-24
• Status Verified: 2022-02
• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-04-05
• Last Update Submitted: 2022-04-05
• Study First Posted: 2022-04-07
• Last Update Posted: 2022-04-07
• Primary Completion: 2023-07-31
• Study Completion: 2023-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Pathologically documented, locally-advanced or metastatic malignancy
• Standard treatment is not available or patient declines
• Adequate organ function

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Exclusion Criteria

• Active brain metastases from non-brain tumors.
• Gastrointestinal (GI) tract disease causing the inability to take oral medication.
• Other protocol specified criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
dose exploration	BPI-421286	Enrollment into the dose exploration cohorts may be from any eligible solid tumor type. Dose escalation will begin with 1-6 subjects treated at the lowest planned dose level. If no DLT is observed, dose escalation will continue to the next planned dose cohort
dose expansion	BPI-421286	dose expansion may proceed with 2 groups consisting of subjects with KRAS p.G12C mutant advanced solid tumors. Dose expansion in these 2 groups may be done concurrently

Primary Outcome Measures

Name	Time	Method
Characterize the safety and tolerability of BPI-421286 in subjects with advanced solid tumor malignancies	20 months	Number of subjects with treatment related adverse events
determine the recommended Phase II dose (RP2D) and preliminarily to develop a suitable dosing regimen	20 months	Number of subjects with dose limiting toxicity

Secondary Outcome Measures

Name	Time	Method
Evaluate the pharmacokinetics of BPI-421286	20 months	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-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286
To evaluate progression-free survival (PFS) following initiation of BPI-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286
To evaluate overall (OS) following initiation of BPI-421286	20 months	Evaluate clinical activity/efficacy of BPI-421286
To evaluate the duration of response (DOR) in subjects with CR or PR as best response	20 months	Evaluate clinical activity/efficacy of BPI-421286
to evaluate the disease control rate (DCR)	20 months	Evaluate clinical activity/efficacy of BPI-421286

Trial Locations

Locations (4)

Wen Li, Ph.D; 🇨🇳 Hangzhou, Zhejiang, China

Yun Fan,Ph.D; 🇨🇳 Hangzhou, Zhejiang, China

Shun Lu, Ph.D; 🇨🇳 Shanghai, China

Dingzhi Huang, Ph.D; 🇨🇳 Tianjin, Tianjin, China