SHP2 Inhibitor BBP-398 in Combination With 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.
Checked against the public recordLast updated Dec 12, 2024 · Source: ClinicalTrials.gov
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1
- Sponsor
- Navire Pharma Inc., a BridgeBio company
- Interventions being studied
- Drug: BBP-398 with nivolumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
Key Inclusion Criteria: * 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. 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 known central nervous system (CNS) tumors or active CNS metastases. * 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 history of allogenic bone marrow transplant. * Patients that have select known or suspected autoimmune disease. * 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.
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands OncologySpringdale, Arkansas
- Scripps Clinic Torrey PinesLa Jolla, California
- Providence Medical FoundationSanta Rosa, California
- Memorial Regional Hospital (Memorial Cancer Institute)Hollywood, Florida
- Moffitt Cancer CenterTampa, Florida
- Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimore, Maryland
- Henry Ford HospitalDetroit, Michigan
- Roswell Park Cancer InstituteBuffalo, New York
- Cleveland ClinicCleveland, Ohio
- Providence Portland Medical CenterPortland, Oregon
- University of Pennsylvania (Abramson Cancer Center)Philadelphia, Pennsylvania
- Medical University of South Carolina (MUSC) - Hollings Cancer CenterCharleston, South Carolina
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 12, 2024. Always confirm current availability with the study team.