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

Phase 1

• Conditions: Advanced Solid Tumor
• Interventions: Drug: BR790

• Registration Number: NCT04891653
• Lead Sponsor: Jiangxi Qingfeng Pharmaceutical Co. Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-05
• Study First Submitted: 2021-05-11
• Study First Submitted QC: 2021-05-12
• Last Update Submitted: 2021-05-12
• Study First Posted: 2021-05-18
• Last Update Posted: 2021-05-18
• Study Start: 2021-06-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
5-65mg QD	BR790	-

Primary Outcome Measures

Name	Time	Method
maximum tolerated dose (MTD)	up to 32 day
recommended phase II clinical study dose (RP2D)	up to 32 day
Dose limiting toxicity (DLT)	up to 32 day

Secondary Outcome Measures

Name	Time	Method
Cmax	up to 32 day
t1/2	up to 32 day
pERK	up to 32 day	the level of pERK in blood
AUC	up to 32 day
ORR	through study completion, an average of 3 years
AE	through study completion, an average of 3 years	Number of participants with treatment-related adverse events as assessed by CTCAE v5.0