SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
Reason given: Business reasons
Key facts
- Where
- Baltimore, Buffalo, Charleston, Cleveland, Detroit, Fairfax, Hollywood, Houston, La Jolla, Philadelphia, Portland, Santa Rosa, Springdale, and Tampa, United StatesSee the 15 sites
- Phase
- Phase 1
Where in United States
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, United StatesNo longer taking part
- Roswell Park Cancer InstituteBuffalo, United StatesNo longer taking part
- Medical University of South Carolina (MUSC) - Hollings Cancer CenterCharleston, United StatesNo longer taking part
- Cleveland ClinicCleveland, United StatesNo longer taking part
- Henry Ford HospitalDetroit, United StatesNo longer taking part
- NEXT OncologyFairfax, United StatesNo longer taking part
- Memorial Regional Hospital (Memorial Cancer Institute)Hollywood, United StatesNo longer taking part
- MD Anderson Cancer CenterHouston, United StatesNo longer taking part
- Millennium Research and Clinical DevelopmentHouston, United StatesNo longer taking part
- Scripps Clinic Torrey PinesLa Jolla, United StatesNo longer taking part
- University of Pennsylvania/Abramson Cancer CenterPhiladelphia, United StatesNo longer taking part
- Providence Portland Medical CenterPortland, United StatesNo longer taking part
- Providence Medical FoundationSanta Rosa, United StatesNo longer taking part
- Highlands OncologySpringdale, United StatesNo longer taking part
- Moffitt Cancer CenterTampa, United StatesNo longer taking part
Trial details
- Who runs it
- Navire Pharma Inc., a BridgeBio company
- Trial code
- NCT05375084
- Record updated
- 12 December 2024
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Patients must have histologically documented, locally advanced and unresectable, or metastatic NSCLC with documentation of a KRAS mutation within the 1 year 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 at least one prior line of systemic therapy, which must include platinum-based doublet chemotherapy and anti-PD-(L)1 therapy; Patients must have experienced progressive or recurrent disease occurring either during treatment or within 90 days after discontinuing anti-PD-(L)1 therapy; Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1; Patients must have adequate organ function.
Exclusion: 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 that have experienced progressive disease (PD) within the first 120 days of initiating treatment with an anti- PD-(L)1 agent (e.g., primary refractory); Patients that have a condition requiring systemic treatment with either corticosteroids (>10 mg prednisone equivalent) or other immunosuppressive medication within 14 days of study start; Patients that have received any live/attenuated vaccine within 30 days of first study treatment; Patients that have a history of allogenic bone marrow transplant; Patients that have select known or suspected autoimmune disease; Patients that have participated in an interventional clinical study within the last 4 weeks; Patients with known central nervous system (CNS) tumors or active CNS metastases.