Combination of GNS561 and Trametinib in Patients With Advanced KRAS Mutated Cholangiocarcinoma
ConditionCholangiocarcinoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorGenfit
About this trial
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
Eligibility criteria
Qualifiers
Histologically confirmed intrahepatic CCA with a documented KRAS mutation.
Patients greater than or equal to 18 years of age.
Patients must have disease progression that is not amenable to potentially curative treatment.
Patients must have received one or two lines of chemotherapy.
Disqualifiers
Previous treatment with a MEK inhibitor or autophagy inhibitor.
Previous treatment with three or more lines of prior chemotherapy.
Extrahepatic CCA with
Cardiovascular disorders: congestive heart failure New York Heart Association ≥ class 2 or left ventricular ejection fraction (LVEF) <50%, arrythmias or cardiac conduction abnormalities. Uncontrolled arterial hypertension or inadequately controlled arterial hypertension, at the discretion of the investigator, based on an average of = >3 BP readings over = >2 sessions.
Trial design
Treatments tested in this trial
- GNS561 + Trametinib
Treatment groups
74 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov