In short
EIK1005 sodium is an investigational substance being studied as a potential cancer treatment. It is a Werner helicase inhibitor, which means it targets a specific protein involved in how cancer cells repair their DNA. One Phase 1 clinical trial (NCT07262619) is currently authorised to evaluate EIK1005 sodium in up to 192 participants with advanced solid tumors, including tumors with high microsatellite instability (MSI-H).
Key points
- EIK1005 sodium is a Werner helicase inhibitor being developed for cancer.
- One authorised Phase 1 trial is testing it in advanced solid tumors.
- The trial plans to enroll up to 192 participants.
- EIK1005 sodium is given as tablets by mouth at different strengths.
- The study also tests EIK1005 sodium combined with pembrolizumab, an immunotherapy given by infusion.
- The main goal is to assess safety and tolerability and find the right dose.
What is EIK1005 sodium?
EIK1005 sodium is an investigational substance, meaning it is not yet approved as a medicine. It is being developed as a potential cancer treatment. In the clinical trial record, the substance is described as a Werner helicase inhibitor. The trial record lists EIK1005 sodium as the active substance under study, with no marketing authorisation mentioned.
How does EIK1005 sodium work?
EIK1005 sodium is described in the trial record as a Werner helicase inhibitor. Werner helicase is a protein that helps cells unwind DNA so it can be repaired or copied. In cancer cells, this protein can help the cells survive and grow. By blocking Werner helicase, EIK1005 sodium is intended to interfere with the ability of cancer cells to repair their DNA, which may make them more likely to die.
Which conditions is EIK1005 sodium studied for?
- Advanced solid tumors: cancers that form solid masses in organs or tissues and have spread or cannot be removed by surgery.
- Microsatellite instability high (MSI-H) tumors: a subgroup of solid tumors that have a specific defect in their DNA repair system, which is mentioned in the trial title.
How is EIK1005 sodium given?
EIK1005 sodium is given as tablets that are taken by mouth. The trial record lists three tablet strengths: 10 mg, 50 mg, and 200 mg. In the combination part of the study, EIK1005 sodium is given together with pembrolizumab, which is given as an intravenous infusion.
What do the clinical trials show?
One clinical trial is currently authorised for EIK1005 sodium. The trial, identified as NCT07262619, is a Phase 1 study. Phase 1 trials are the first time a substance is tested in people. The main purpose is to find out whether the substance is safe and what dose can be given.
The trial plans to enroll up to 192 participants with advanced solid tumors. The study is described as having two parts. Part 1 evaluates the safety and tolerability of EIK1005 sodium as a single treatment (monotherapy) and in combination with pembrolizumab, to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD). Part 2 evaluates the safety and tolerability of EIK1005 sodium for dose optimization.
The primary outcomes measured in this trial are dose-limiting toxicities (DLTs) and adverse events (AEs). DLTs are side effects that are severe enough to prevent giving a higher dose. Adverse events are any unwanted medical events that occur during the study.
The trial is currently in the status Authorised, meaning it has received approval to begin but may not yet be recruiting participants.
What side effects are known?
The clinical trial record does not provide a list of side effects for EIK1005 sodium. The trial is designed to measure safety and tolerability, and the side effects will be collected as part of the study. No supplementary sources with side effect information were provided.