Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
← catalyst calendarNCT05874414 · readout ≤ 498 d
Sponsored by Genfit (industry) · GNFT.PA — their whole pipeline →.
Phase
Phase 1/2
Status
Recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
98estimated
Sites
11
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2023-08-21 | actual | When the study began enrolling |
| Primary completion | Dec 2027 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2023-05-24 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-13 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Cholangiocarcinoma
Intervention
- Drug: GNS561 + Trametinib — also filed as Ezurpimtrostat (GNS561)
Primary outcomes
what the primary-completion date above is the date OFIncidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)
measured At the end of Cycle 1 (each Cycle is 21 days)
Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)
measured Up to 11 months (estimated)
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