NCT05369312

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Betta Pharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Solid Tumor
• Non-small Cell Lung Cancer
• Pancreatic Cancer
• Colorectal Cancer

Interventions

Type	Name	Description
DRUG	BPI-442096	Subjects will receive BPI-442096 until disease progression

Timeline

• Start date: 2022-06-01
• Primary completion: 2024-05-01
• Completion: 2025-05-01
• First posted: 2022-05-11
• Last updated: 2022-06-21

Locations

5 sites across 1 country: China