SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedBBP-398 with nivolumab

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · KRAS

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Dec 12, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Terminated

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?15 U.S. locations

Locations may change over time.

Who runs it?Navire Pharma Inc., a BridgeBio company

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Biomarkers

KRAS→

Treatment approach

Immunotherapy→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

Key
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

Reasons someone may not be able to joinExclusion 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.

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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