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

NCT ID: NCT05302843

Last Updated: 2022-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-22

Study Completion Date

2023-12-31

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

Detailed Description

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Conditions

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Metastasis, Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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dose exploration and dose expansion

Patients receive BPI-28592 PO. Cycles repeat every 28 days.

Group Type EXPERIMENTAL

BPI-28592

Intervention Type DRUG

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Interventions

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BPI-28592

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

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Betta Pharmaceuticals Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sir Run Run Shaw Hospital (SRRSH), affiliated with the Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hongming Pan, Ph.D

Role: CONTACT

0571-86006922

Facility Contacts

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Hongming Pan, Ph.D

Role: primary

References

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Sheng J, Chen H, Fu B, Pan H, Wang J, Han W. BPI-28592 as a novel second generation inhibitor for NTRK fusion tumors. NPJ Precis Oncol. 2024 Sep 11;8(1):198. doi: 10.1038/s41698-024-00686-8.

Reference Type DERIVED
PMID: 39256512 (View on PubMed)

Other Identifiers

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BTP-661211

Identifier Type: -

Identifier Source: org_study_id

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