Clinical Trial

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

Recruiting Phase 1/2
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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
Protocol Amendment History 3 changes
notable Enrollment increased: 74 -> 98 participants 2026-07-14
notable Primary completion pushed: 2026-05 -> 2027-12 2026-07-14
minor Completion pushed: 2026-10 -> 2028-06 2026-07-14
Trial Details
NCT Number NCT05874414
Lead Sponsor Genfit
Conditions Cholangiocarcinoma
Enrollment 98 participants
Start Date 2023-08-21
Primary Completion 2027-12 (estimated)
Study Completion 2028-06 (estimated)
Updated on ClinicalTrials.gov 2026-07-13