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

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

Official Title
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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

Conditions
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Metastasis, Neoplasm

Intervention / Treatment
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* Drug: BPI-28592


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dose exploration and dose expansion<br>Patients receive BPI-28592 PO. Cycles repeat every 28 days. | Drug: BPI-28592<br>* Characterize the pharmacokinetics (PK)，safety，antitumor activity of BPI-28592<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the pharmacokinetics of BPI-28592 | Blood plasma concentration | about 20 months | 
| 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 | 
| 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 | 
| to evaluate the disease control rate (DCR) | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months | 
| To evaluate progression-free survival (PFS) following initiation of BPI-28592 | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months | 
| To evaluate overall (OS) following initiation of BPI-28592 | Evaluate clinical activity/efficacy of BPI-28592 | about 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NTRK1/2/3, fusion