Status:
TERMINATED
SHP2 Inhibitor BBP-398 in Combination With Nivolumab in Patients With Advanced Non-Small Cell Lung Cancer With a KRAS Mutation
Lead Sponsor:
Navire Pharma Inc., a BridgeBio company
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Non Small Cell Lung Cancer
Solid Tumor
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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 ...
Detailed Description
The primary objective for Phase 1a Dose Escalation is to evaluate the safety, tolerability, and RP2D of BBP-398, a SHP2 inhibitor, when used in combination with nivolumab in patients with advanced NSC...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
October 20 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT05375084
Start Date
October 20 2022
End Date
July 15 2024
Last Update
December 12 2024
Active Locations (15)
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1
Highlands Oncology
Springdale, Arkansas, United States, 72762
2
Scripps Clinic Torrey Pines
La Jolla, California, United States, 92037
3
Providence Medical Foundation
Santa Rosa, California, United States, 95403
4
Memorial Regional Hospital (Memorial Cancer Institute)
Hollywood, Florida, United States, 33021