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OncoMatch/Clinical Trials/NCT05874414

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

Is NCT05874414 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies GNS561 + Trametinib for cholangiocarcinoma.

Phase 1/2RecruitingGenfitNCT05874414Data as of May 2026

Treatment: GNS561 + Trametinib — 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

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Extracted eligibility criteria

Cancer type

Cholangiocarcinoma

Biomarker criteria

Required: KRAS mutation

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Max 2 prior lines
Min 1 prior line

Must have received: chemotherapy

Patients must have received one or two lines of chemotherapy

Cannot have received: MEK inhibitor

Previous treatment with a MEK inhibitor

Cannot have received: autophagy inhibitor

Previous treatment with...autophagy inhibitor

Cannot have received: chemotherapy

Previous treatment with three or more lines of prior chemotherapy

Lab requirements

Blood counts

absolute neutrophil count ≥1000 cells/μl, platelet count ≥75,000 cells/μl, hemoglobin ≥9 g/dl

Kidney function

estimated glomerular filtration rate ≥60 ml/min

Liver function

aspartate aminotransferase or alanine aminotransferase less than or equal to 3 × upper limit of normal

Cardiac function

corrected qt interval by fridericia's (qtcf) interval ≤470 msec

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • USC Norris Comprehensive Cancer Center · Los Angeles, California
  • LA Cancer Network · Los Angeles, California
  • Orlando Health · Orlando, Florida
  • Moffitt Cancer Center · Tampa, Florida
  • University Of Chicago Medical Center · Chicago, Illinois

Showing up to 5 US sites. See all sites on ClinicalTrials.gov →

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