Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma
Genfit
Summary
This is an open-label, multicenter Phase 1b/2a study to evaluate safety, pharmacokinetics (PK), pharmacodynamics (PD) and efficacy of GNS561 in combination with trametinib in Advanced KRAS Mutated Cholangiocarcinoma after failure of standard-of-care first line therapy
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Histologically confirmed intrahepatic CCA with a documented KRAS mutation. 2. Patients greater than or equal to 18 years of age. 3. Patients must have disease progression that is not amenable to potentially curative treatment. 4. Patients must have received one or two lines of chemotherapy. 5. Patients must have at least one measurable disease by RECIST v1.1. 6. Performance status (ECOG) 0-1. 7. Adequate organ baseline function defined as follows: absolute neutrophil count ≥1000 cells/μL, platelet count ≥75,000 cells/μL, hemoglobin ≥9 g/dL, aspartate aminotransferase or…
Interventions
- DrugGNS561 + Trametinib
GNS561: 50mg, 100mg, 150mg, 200mg and trametinib: 1mg, 1.5mg and 2mg
Locations (11)
- USC Norris Comprehensive Cancer CenterLos Angeles, California
- LA Cancer NetworkLos Angeles, California
- Orlando HealthOrlando, Florida
- Moffitt Cancer CenterTampa, Florida
- University Of Chicago Medical CenterChicago, Illinois
- Roswell Park Cancer InstituteBuffalo, New York