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

Sponsor

Betta Pharmaceuticals Co., Ltd. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05315180

Collaborator

(none)

Enrollment

Locations

Arms

23.2

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Malignant Neoplasms Metastatic Cancer	Drug: BPI-421286	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 24, 2021

Anticipated Primary Completion Date :

Jul 31, 2023

Anticipated Study Completion Date :

Jul 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: dose exploration 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	Drug: BPI-421286 Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation
Experimental: dose expansion 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	Drug: BPI-421286 Characterize the pharmacokinetics (PK)，safety，effcicay of BPI-421286 following administration as an oral Tablet formulation

Arm

Intervention/Treatment

Experimental: dose exploration

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

Drug: BPI-421286

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

Experimental: dose expansion

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

Drug: BPI-421286

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

Outcome Measures

Primary Outcome Measures

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

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 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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shun Lu, Ph.D	Shanghai	Shanghai	China	200030
2	Dingzhi Huang, Ph.D	Tianjin	Tianjin	China
3	Wen Li, Ph.D	Hangzhou	Zhejiang	China	310009
4	Yun Fan,Ph.D	Hangzhou	Zhejiang	China	310022
5	Shun Lu, Ph.D	Shanghai		China	200030