OncoMatch/Clinical Trials/NCT05874414
Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
Is NCT05874414 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1/2 trial studies GNS561 + Trametinib for cholangiocarcinoma.
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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Targeted therapy
Cancer type
Cholangiocarcinoma
Biomarker criteria
Required: KRAS mutation
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
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 →Frequently asked questions
Is NCT05874414 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior MEK inhibitor, autophagy inhibitor, chemotherapy disqualifies patients from enrollment.
Does this trial require KRAS?
Yes, KRAS mutation is a required biomarker for enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages