The Christ Hospital
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
This is a single site, open-label, study to define the safety profile and overall response rate (ORR) and duration of response (DOR) activity of JBI-802 alone and in combination with Pembrolizumab in participants with Non-Small Cell Lung Cancer harboring an STK11 mutation. Dose of study medication will be 10 mg orally once daily, 4 days on and 3 days off cycle. Dose of Pembrolizumab will be 200mg every 3 weeks.
Inclusion Criteria: 1. Males or females aged ≥18 years at Screening. 2. Participants with a histologically confirmed diagnosis of locally advanced or metastatic NSCLC harboring an STK11 mutation. 3. Screening laboratory values: * Absolute neutrophil count (ANC) ≥1500 cells/mm3. * Platelet count ≥100,000 cells/mm3. * Total bilirubin ≤1.5×ULN. Patients with Gilbert's syndrome may be enrolled with up to 3.0xULN. * AST and ALT ≤2.5×ULN (unless liver metastases are present then up to 5×ULN is allowed). * Calculated creatinine clearance (CrCL) ≥40 mL/min calculated per Institutional…
LSD1/HDAC6 Inhibitor
PD-1
Arctuva estimate
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