drugset
drugset / Trial / NCT05874414

Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma

NCT05874414 ↗

Phase 1/2 Recruiting 98 enrolled Genfit
NaSequentialOpen-labelTreatment

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

Timeline

Start
2023-08-21
Primary completion
2027-12
Completion
2028-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Ezurpimtrostat Small molecule 50 mg —
Subject Ezurpimtrostat Small molecule 100 mg —
Subject Ezurpimtrostat Small molecule 150 mg —
Subject Ezurpimtrostat Small molecule 200 mg —
Subject Trametinib Small molecule 1 mg —
Subject Trametinib Small molecule 1.5 mg —
Subject Trametinib Small molecule 2 mg —

Indications

cholangiocarcinoma