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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Genfit
Study ID
NCT05874414
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Cholangiocarcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GNS561 + Trametinib — DRUG
    GNS561: 50mg, 100mg, 150mg, 200mg and trametinib: 1mg, 1.5mg and 2mg

Study Details

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

Key Dates

Start date
Aug 21, 2023
Status verified
May 2026
Primary completion
May 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
74 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: GNS561+Trametinib
    Phase 1b Dose Finding Patients will receive GNS561 (50mg QD; 100mg QD; 150mg; 200mg QD) and trametinib (2mg QD; 1.5mg QD; 1mg QD) in a dose escalation/de-escalation design to determine the maximum tolerated dose (MTD) of the combination. Experimental: Phase 2a Patients will receive GNS561 and trametinib at the recommended dose of the combination determined during Phase 1b

Primary Outcome Measure

Incidence of dose limiting toxicity (DLT) of GNS561 with trametinib (Phase 1b) [ Time Frame: At the end of Cycle 1 (each Cycle is 21 days) ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
LACN Aneheim Flagship OfficeLos AngelesCalifornia92805
LACN Aneheim Flagship Office
USC Norris Comprehensive Cancer CenterLos AngelesCalifornia90033
USC Norris Comprehensive Cancer Center
Orlando HealthOrlandoFlorida32806
Orlando Health
Moffitt Cancer CenterTampaFlorida33612
Moffitt Cancer Center
University Of Chicago Medical CenterChicagoIllinois60637
University Of Chicago Medical Center
Roswell Park Cancer InstituteBuffaloNew York14263-
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-
University of Texas, MD Anderson Cancer CenterHoustonTexas77030
The University of Texas, MD Anderson Cancer Center
University of Virginia Comprehensive Cancer CenterCharlottesvilleVirginia22908
University of Virginia Health System
Froedtert Hospital and the Medical College of WisconsinMilwaukeeWisconsin53226
Medical College of Wisconsin

Find similar trials in Los Angeles, CA

By research site
LACN Aneheim Flagship Office· Los Angeles, CAUSC Norris Comprehensive Cancer Center· Los Angeles, CAOrlando Health· Orlando, FLMoffitt Cancer Center· Tampa, FLUniversity Of Chicago Medical Center· Chicago, ILRoswell Park Cancer Institute· Buffalo, NY

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