Lung Cancer Clinical Trial
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.
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 NSCLC with a KRAS mutation who have failed standard of care treatment.
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.
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.
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There are 7 Locations for this study
Springdale Arkansas, 72762, United States
La Jolla California, 92037, United States
Santa Rosa California, 95405, United States
Tampa Florida, 33612, United States
Cleveland Ohio, 44195, United States
Portland Oregon, 97213, United States
Fairfax Virginia, 22031, United States
How clear is this clinincal trial information?
Introducing, the Journey Bar
Use this bar to access information about the steps in your cancer journey.