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Phase 1/2Recruiting

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

Phase 1b/2a Study of GNS561 in Combination With Trametinib in Advanced KRAS Mutated Cholangiocarcinoma

Sponsor
Genfit (Industry)
Enrollment
98 planned
Conditions
Cholangiocarcinoma
Interventions
GNS561 + Trametinib
Ages
adults, older adults
Registry
NCT05874414

Full record on ClinicalTrials.gov

From the registry

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

Primary outcomes

  • Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b)
  • Objective response rate (ORR) of the combination of GNS561 with trametinib (Phase 2a)

History

  1. Study completion expected

  2. Primary completion expected

  3. Last registry update

  4. Started

  5. Registered