Sponsor: Navire Pharma, Inc
Sponsor Study ID: NAV-1004
Study Title: A Phase 1 Study of the SHP2 Inhibitor BBP 398 (formerly known as IACS 15509) in Combination with the Programmed Death Receptor 1 Blocking Antibody Nivolumab in Patients with Advanced Non Small Cell Lung Cancer with a KRAS Mutation
CTO #: 103707
NCT Number: NCT05375084
Phase: I
Protocol Type: Treatment
Age Group: Adults
Disease Sites: Lung
Study Objectives: The primary objective for Phase 1a Dose Escalation is to evaluate the safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398, a SHP2 inhibitor, when used in combination with nivolumab in patients with advanced non-small cell lung cancer (NSCLC) with a KRAS mutation who have failed standard of care treatment. The primary objective for Phase 1b Dose Expansion is to evaluate the antitumor activity of BBP-398, as defined by the ORR (per investigator) according to RECIST v1.1, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.