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

UVA Tracking #
Principal Investigator
Matthew J Reilley
Contact Phone
Official Trial Title
Phase 1b/2a Study of GNS561 in Combination with Trametinib in Advanced KRAS Mutated Cholangiocarcinoma
Study Description

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with Advanced KRAS Mutated Cholangiocarcinoma (CCA) to participate in a research study. This study will evaluate the safety and efficacy of GNS561 given in combination with trametinib. The study drugs GNS561 and trametinib in combination are considered investigational, which means that the combination has not been approved by the United States Food and Drug Administration, for the treatment of patients with CCA. The study includes 2 parts. The first part, also called Phase 1b, is aimed at evaluating the safety and tolerability of GNS561 when given in combination with trametinib and to determine the recommended doses for the second part of the study, also called Phase 2a. The purpose of the Phase 2a is to evaluate how well the combination of GNS561 with trametinib works and to further evaluate the safety and the tolerability of the combination at the recommended dose in subjects with your condition, presenting with KRAS mutated CCA after treatment failure with first-line therapy.

The study involves receiving the investigational drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn and talking to the study doctor. If you are eligible for the study and consent to participate, your involvement includes a screening period of up to 28 days with at least 2 visits, a treatment period where you have weekly visits for the first two 21-day cycles and visits every 21 days for the following 10 cycles, an end of study treatment visit, a safety follow-up visit, and an observational follow-up period via phone calls to keep track of how you are doing. How long you will be on the study depends on your ability to safely tolerate the study treatment, your response to study treatment, and your and/or your study doctor’s decision for you to continue study treatment.

The investigational drugs GNS561 and trametinib, as well as all study-related procedures including doctor's visits and laboratory tests, will be provided at no cost to you.

More information about this study can be found at https://clinicaltrials.gov/study/NCT05874414



None Reimbursement - $75 per visit Meal Reimbursement - $50 covering 2 meals per visit Hotel Reimbursement – Up to $175 per night