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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05302843

Enrollment

Registered

2022-03-31

Start date

2021-03-22

Completion date

2023-12-31

Last updated

2022-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastasis, Neoplasm

Keywords

NTRK1/2/3, fusion

Brief summary

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

Interventions

DRUGBPI-28592

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Characterize the safety and tolerability of BPI-28592 in subjects with advanced solid tumor malignancies	about 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	about 20 months	Number of subjects with dose limiting toxicity

Secondary

Measure	Time frame	Description
To evaluate the duration of response (DOR) in subjects with CR or PR as best response	about 20 months	Evaluate clinical activity/efficacy of BPI-28592
to evaluate the disease control rate (DCR)	about 20 months	Evaluate clinical activity/efficacy of BPI-28592
Evaluate the pharmacokinetics of BPI-28592	about 20 months	Blood plasma concentration
To evaluate overall (OS) following initiation of BPI-28592	about 20 months	Evaluate clinical activity/efficacy of BPI-28592
To evaluate progression-free survival (PFS) following initiation of BPI-28592	about 20 months	Evaluate clinical activity/efficacy of BPI-28592
To determine overall response rate (ORR),calculated as the proportion of subjects with confirmed complete (CR) or partial response (PR) to BPI-28592	about 20 months	Evaluate clinical activity/efficacy of BPI-28592

Countries

China

Contacts

Primary ContactHongming Pan, Ph.D

shonco@sina.cn0571-86006922

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026