Phase 1 Study of BPI-442096 in Advanced Solid Tumor Patients

Status Not yet recruiting

Clinical Trial Summary

A first-in-human study to evaluate the safety, tolerability and maximum tolerated dose (MTD) and establish the recommended phase 2 dose (RP2D) of BPI-442096, a SHP2 inhibitor, in patients with advanced solid tumors.

Clinical Trial Description

The first-in-human (FIH) study of BPI-442096 will be an open-label, non-randomized, Phase 1 study utilizing a modified "3+3" dose escalation followed by an expansion phase in patients with KRAS G12 mutation, class-3 BRAF mutation, NF1 LOF mutation or RTK mutation, amplification or rearrangement advanced solid tumors. The primary objective is to determine safety and tolerability of BPI-442096, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity of BPI-442096. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05369312
Study type	Interventional
Source	Betta Pharmaceuticals Co., Ltd.
Contact	Yilong Wu, Ph.D
Phone	020-83525210
Email	syylwu@live.cn
Status	Not yet recruiting
Phase	Phase 1
Start date	June 2022
Completion date	May 1, 2025

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