NCT04528836

First-in-Human Study of the SHP2 Inhibitor BBP-398 in Patients With Advanced Solid Tumors

A Phase 1/1B First-in-Human Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Patients With Advanced Solid Tumors

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Navire Pharma Inc., a BridgeBio company · Industry
• Sex: All
• Age: 18 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 BBP-398, a SHP2 inhibitor, in patients with advanced solid tumors.

Detailed description

The first-in-human (FIH) study of BBP-398 will be an open-label, sequential-cohort, non-randomized, Phase 1/1B study utilizing BOIN dose escalation followed by an expansion phase in patients with MAPK pathway- or RTK-driven advanced solid tumors. The primary objective is to determine safety and tolerability of BBP-398, the MTD and RP2D. The secondary objectives are to assess the pharmacokinetic (PK) and pharmacodynamic (PD) profile, preliminary anti-tumor activity, objective response rate (ORR, complete response + partial response rate) and the duration of response (DoR) of BBP-398. The exploratory objective is to assess predictive biomarkers of response.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	BBP-398 (Formerly known as IACS-15509)	oral capsules

Timeline

• Start date: 2020-11-12
• Primary completion: 2024-03-22
• Completion: 2024-07-30
• First posted: 2020-08-27
• Last updated: 2024-12-12

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study