TerminatedPhase 1NCT05375084

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

StatusTerminated
PhasePhase 1
U.S. locations15
SponsorNavire Pharma Inc., a BridgeBio company
01
Study overview

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
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

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.

04
Study sites

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.

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