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

Qingfeng Pharmaceutical

Status and phase

Unknown

Phase 1

Conditions

Advanced Solid Tumor

Treatments

Drug: BR790

Study type

Interventional

Funder types

Industry

Identifiers

NCT04891653

QF-BR790-101

Details and patient eligibility

About

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.

Enrollment

48 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.