A Phase I Study of BR790 in Subjects With Advanced Solid Tumors

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

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-30

Study Completion Date

2023-12-31

Brief Summary

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The purpose of the study was to evaluate the safety and tolerability of BR790 tablets as an oral monotherapy in subjects with advanced solid tumors, and to determine dose-limiting toxicity (DLT), maximum tolerated dose (MTD) and/or recommended phase II clinical trial dose (RP2D) .The study is divided into two phases: dose escalation phase and dose expansion phase.

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Detailed Description

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Conditions

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Advanced Solid Tumor

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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5-65mg QD

Group Type EXPERIMENTAL

BR790

Intervention Type DRUG

Subjects will receive oral administration of BR790.

Interventions

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BR790

Subjects will receive oral administration of BR790.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Sign informed consent voluntarily.
* Age ≥18 and ≤75 years old.
* Subjects with advanced solid tumors diagnosed by histology or cytology，whose desease progressed after standard treatment or have no standard treatment.
* Had at least one measurable lesion.
* ECOG≤1.
* Expected survival period ≥ 3 months.

Exclusion Criteria

* Any previous treatment with SHP-2 inhibitor.
* Symptomatic brain metastases.
* Subjects with thoracic/ascites fluid that need drainage or intervention.
* Subjects with not enough organ functional reserve at baseline, which met at least one of the following criteria： ANC\<1.5×10\^9/L PLT\<100×10\^9/L Hb\<90g/L TBIL\>1.5×ULN ALT, AST\>2.5×ULN (without liver metastases) or ALT, AST\>5×ULN (with liver metastases), Cr \>1.5×ULN.
* With uncontrolled severe disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No