The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Males or females aged ≥18 years at Screening.
Participants with a histologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an STK11 mutation.
Absolute neutrophil count (ANC) ≥1500 cells/mm3.
Platelet count ≥100,000 cells/mm3.
Treatment with systemic anticancer therapy or an investigational agent within 2 weeks or 5 half-lives, whichever is shorter, prior to start of study drug treatment.
Major surgery ≤21 days prior to starting study drug or has not recovered from adverse effects of such procedure.
Surgery (eg, stomach bypass) or medical condition that might significantly affect absorption of medicines (as judged by the Investigator).
Radiotherapy within 2 weeks prior to start of study drug treatment (palliative radiation or stereotactic radiosurgery within 7 days prior to start of study treatment). Participants must have recovered from all radiotherapy-related toxicities.
Parallel
JBI-802
DrugLSD1/HDAC6 Inhibitor
Pembrolizumab
DrugPD-1
Incidence of Adverse Events
Characterized overall and by type, seriousness, relationship to study treatment, timing, and severity graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Investigator Assessed ORR
Investigator-assessed overall response rate (ORR) indicated by stable disease, partial response or complete response and progression free survival (PFS) as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
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