NCT05480865

SHP2 Inhibitor BBP-398 in Combination With Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

A Phase 1 Study of the SHP2 Inhibitor BBP-398 (Formerly Known as IACS-15509) in Combination With the KRAS-G12C Inhibitor Sotorasib in Patients With Advanced Solid Tumors and a KRAS-G12C Mutation

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Navire Pharma Inc., a BridgeBio company · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with sotorasib, a KRAS-G12C inhibitor (KRAS-G12Ci), in patients with a KRAS-G12C mutation. The study involves 2 parts: Phase 1a Dose Escalation and Phase 1b Dose Expansion/Optimization.

Detailed description

The primary objectives for Phase 1a Dose Escalation are to evaluate safety and tolerability, and recommend a phase 1b dose (RP1bD) of the combination. The primary objectives for Phase 1b Dose Expansion/Optimization are to evaluate safety and tolerability, and the antitumor activity (defined by the ORR assessed by the investigator according to RECIST v1.1) of BBP-398 when used in combination with sotorasib across two dose regimens in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with a KRAS-G12C mutation and who are KRAS-G12Ci naïve, and recommend a phase 2 dose (RP2D) of the combination.

Conditions

• Solid Tumor, Adult
• Metastatic Solid Tumor
• Metastatic NSCLC
• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	BBP-398	BBP-398 administered orally
DRUG	sotorasib	sotorasib administered orally

Timeline

• Start date: 2022-07-06
• Primary completion: 2024-08-22
• Completion: 2024-08-22
• First posted: 2022-07-29
• Last updated: 2024-12-12

Locations

25 sites across 7 countries: Australia, Denmark, France, Greece, Italy, Netherlands, Spain

Regulatory

• FDA-regulated drug study