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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Highlands Oncology
Springdale, Arkansas, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Phase 1a Dose Escalation: Assess safety, tolerability, and recommended phase 2 dose (RP2D) of BBP-398 in combination with nivolumab
Time frame: Completion of 1 Cycle (28 days)
Phase 1b Dose Expansion: Assess antitumor activity of BBP-398 in combination with nivolumab
Anti-tumor activity will be defined by objective response rate (ORR) according to RECIST v1.1
Time frame: Completion of 1 Cycle (28 days)
Assess preliminary antitumor activity of BBP-398 in combination with nivolumab
Anti-tumor activity will be defined by objective response rate (ORR) \[escalation\], duration of response (DOR) and progression free survival (PFS), as defined by RECIST v1.1. and overall survival (OS) \[both escalation and expansion\]
Time frame: Completion of 1 Cycle (28 days)
Phase 1b Dose Expansion: Assess safety and tolerability of BBP-398 at the RP2D, in combination with nivolumab
Time frame: Completion of 1 Cycle (28 days)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Providence Medical Foundation
Santa Rosa, California, United States
Memorial Regional Hospital (Memorial Cancer Institute)
Hollywood, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
...and 5 more locations