This is a Phase 1 study of BBP-398, a SHP2 inhibitor, in combination with nivolumab, a
PD-1 antibody, in patients with NSCLC with a KRAS mutation. The study involves 2 parts:
Phase 1a Dose Escalation and Phase 1b Dose Expansion.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05375084.
The primary objective for Phase 1a Dose Escalation is to evaluate the safety,
tolerability, and RP2D of BBP-398, a SHP2 inhibitor, when used in combination with
nivolumab in patients with advanced 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.
Lead OrganizationNavire Pharma Inc., a BridgeBio company
