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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
Navire Pharma Inc., a BridgeBio company
Study ID
NCT05375084
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • BBP-398 with nivolumab — DRUG
    BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)

Study Details

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.

Key Dates

Start date
Oct 20, 2022
Status verified
Dec 2024
Primary completion
Apr 12, 2024
Completion
Jul 15, 2024

Study Design

Enrollment
21 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Level 1
    Level 1 oral capsules administered in combination with nivolumab
  • Experimental: Dose Escalation Level 2
    Level 2 oral capsules administered in combination with nivolumab
  • Experimental: Dose Escalation Level 3
    Level 3 oral capsules administered in combination with nivolumab
  • Experimental: Dose Expansion
    RP2D defined dose. Oral capsules administered in combination with nivolumab

Primary Outcome Measure

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) ]

Locations (15)

FacilityCityStateZIPSite coordinators
Highlands OncologySpringdaleArkansas72762-
Scripps Clinic Torrey PinesLa JollaCalifornia92037-
Providence Medical FoundationSanta RosaCalifornia95403-
Memorial Regional Hospital (Memorial Cancer Institute)HollywoodFlorida33021-
Moffitt Cancer CenterTampaFlorida33612-
Johns Hopkins Sidney Kimmel Comprehensive Cancer CenterBaltimoreMaryland21224-
Henry Ford HospitalDetroitMichigan48202-
Roswell Park Cancer InstituteBuffaloNew York14203-
Cleveland ClinicClevelandOhio44195-
Providence Portland Medical CenterPortlandOregon97213-
University of Pennsylvania (Abramson Cancer Center)PhiladelphiaPennsylvania19104-
Medical University of South Carolina (MUSC) - Hollings Cancer CenterCharlestonSouth Carolina29425-
MD Anderson Cancer CenterHoustonTexas77030-
Millennium Research and Clinical DevelopmentHoustonTexas77090-
NEXT OncologyFairfaxVirginia22031-

Find similar trials in Springdale, AR

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
Highlands Oncology· Springdale, ARScripps Clinic Torrey Pines· La Jolla, CAProvidence Medical Foundation· Santa Rosa, CAMemorial Regional Hospital (Memorial Cancer Institute)· Hollywood, FLMoffitt Cancer Center· Tampa, FLJohns Hopkins Sidney Kimmel Comprehensive Cancer Center· Baltimore, MD

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