A Phase 1 Study of the SHP2 Inhibitor BBP-398 (formerly known as IACS-15509) in combination with the Programmed Death Receptor-1 Blocking Antibody Nivolumab in Patients with Advanced Non-Small Cell Lung Cancer with a KRAS Mutation
Details
Status
Open: Currently recruiting participants.
Closed: Recruitment either has not started or has paused or completed.
Study Type
Interventional (clinical trials): Test treatments.
Observational: Conduct surveys and interviews, study medical records and otherwise observe people or groups over time.
Interventional
Study Phase
Each study phase tests different aspects of the medication or treatment:
- Phase I: safety and dosing
- Phase II: effectiveness and side effects
- Phase III: efficacy compared to standard treatments
- Phase IV: long-term safety after approval for use
I
Location(s)
Johns Hopkins study sites. Additional study locations may be found on ClinicalTrials.gov.
Johns Hopkins Bayview Medical Center
4940 Eastern Ave Baltimore, MD 21224
Keywords
Contact Us
(410) 955-8964Brief Summary
. You will be supplied with BBP-398 capsules to take home with you. You will be instructed to take BBP-398 orally once daily in the morning at about the same time each day with about a cup (8 ounces) of water. Nivolumab: Nivolumab will be given by an intravenous (IV) (directly into a vein in your arm) infusion. The infusion will start 30 minutes after you take your BBP-398 and it will last approximately 30 minutes.
Eligibility
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.