SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
NCT ID: NCT05375084
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
21 participants
INTERVENTIONAL
2022-10-20
2024-07-15
Brief Summary
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Detailed Description
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The primary objective for Phase 1b Dose Expansion is to evaluate the antitumor activity of BBP-398, as defined by the ORR (per investigator) according to RECIST v1.1, when used in combination with nivolumab in patients with advanced NSCLC with a KRAS mutation who have failed standard of care treatment.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation Level 1
Level 1 oral capsules administered in combination with nivolumab
BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Dose Escalation Level 2
Level 2 oral capsules administered in combination with nivolumab
BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Dose Escalation Level 3
Level 3 oral capsules administered in combination with nivolumab
BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Dose Expansion
RP2D defined dose. Oral capsules administered in combination with nivolumab
BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Interventions
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BBP-398 with nivolumab
BBP-398 administered orally once a day (QD); nivolumab administered intravenously every 4 weeks (Q4wks)
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Navire Pharma Inc., a BridgeBio company
INDUSTRY
Responsible Party
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Locations
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Highlands Oncology
Springdale, Arkansas, United States
Scripps Clinic Torrey Pines
La Jolla, California, United States
Providence Medical Foundation
Santa Rosa, California, United States
Memorial Regional Hospital (Memorial Cancer Institute)
Hollywood, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States
Henry Ford Hospital
Detroit, Michigan, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
Providence Portland Medical Center
Portland, Oregon, United States
University of Pennsylvania (Abramson Cancer Center)
Philadelphia, Pennsylvania, United States
Medical University of South Carolina (MUSC) - Hollings Cancer Center
Charleston, South Carolina, United States
MD Anderson Cancer Center
Houston, Texas, United States
Millennium Research and Clinical Development
Houston, Texas, United States
NEXT Oncology
Fairfax, Virginia, United States
Countries
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Other Identifiers
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NAV-1004
Identifier Type: -
Identifier Source: org_study_id