A Study of Open-label Orally Administered JBI-802 Alone or in Combination With Pembrolizumab in Patients With Advanced NSCLC Tumors Harboring an STK11 Mutation
The Christ Hospital
Summary
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
Description
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugJBI-802
LSD1/HDAC6 Inhibitor
- DrugPembrolizumab
PD-1
Location
- The Christ HospitalCincinnati, Ohio