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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navire Pharma Inc., a BridgeBio company
• Collaborator: Amgen

Criteria

Key Inclusion Criteria:

• Patients must have histologically documented, locally advanced and unresectable, or metastatic solid tumor with documentation of a KRAS-G12C mutation within 2 years prior to screening.

• Patients must have measurable disease by RECIST v1.1.

• Patients must have a minimum life expectancy of >12 weeks after start of study treatment.

• Patients must have progression or disease recurrence on or after all available standard of care therapies.

• Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.

• Patients must have adequate organ function.

Key Exclusion Criteria:

• Patients that have participated in an interventional clinical study within the last 4 weeks.

• Patients that have received radiotherapy or proton therapy with a limited field of radiation for palliation within 1 week of the start of study treatment, OR radiation to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the start of study treatment.

• Patients with untreated and/or active CNS metastases.

• Patients that have a history of allogenic bone marrow transplant.