A Study of Orally Administered JBI-802 Alone or in Combination With Pembrolizumab for Pati
The purpose of this study is to determine the overall safety and tolerability of JBI-802 as single agent and in combination with Pembrolizumab.
| Condition(s) | Lung Cancer (NSCLC) |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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. |
| Who can participate | 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 standard. * Prothrombin time (PT) or activated partial thromboplastin time (aPTT) * 1.5×ULN if participant is not anticoagulated (Note: If participant is on anticoagulants, the participant must be on a stable dose fo |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | The Christ Hospital |
| Locations | Cincinnati, Ohio, United States |
| Start date | 2025-04-29 |
| NCT ID | NCT07207395 |
| Official listing | https://clinicaltrials.gov/study/NCT07207395 |