EIK1004 BIS-tartrate

Table of contents

• What is EIK1004 BIS-tartrate?
• How does EIK1004 BIS-tartrate work?
• Which conditions is EIK1004 BIS-tartrate studied for?
• How is EIK1004 BIS-tartrate given?
• What do the clinical trials show?
• What side effects are known?

What is EIK1004 BIS-tartrate?

EIK1004 BIS-tartrate is a chemically synthesised substance being developed by Eikon Therapeutics, Inc. as an investigational medicine.^[1] It is also known by the development code IMP1707. The substance is classified in the therapeutic area of neoplasms, meaning it is being studied in cancer. EIK1004 has no marketing authorisation in the product records, so it is not yet an approved medicine.^[1] The product names in the registry are EIK1004 20mg Tablets and EIK1004 5mg Tablets.

How does EIK1004 BIS-tartrate work?

The trial records do not state a specific molecular target or mechanism of action for EIK1004. The study is designed to evaluate the safety and tolerability of EIK1004 as monotherapy, and to determine the maximum tolerated dose (MTD) or maximum administered dose (MAD) and the recommended dose for expansion (RDE).^[1] Because this is a Phase 1/2 dose-escalation and dose-optimization study, the main goal is to find a dose that can be given safely while looking for signs of anti-tumor activity.

Which conditions is EIK1004 BIS-tartrate studied for?

The only condition listed in the trial data is:

• Advanced solid tumors — cancers that have spread from where they started and are not considered curable with surgery or radiation alone.

How is EIK1004 BIS-tartrate given?

EIK1004 is given by mouth as a tablet. The trial uses two strengths: 5 mg tablets and 20 mg tablets.^[1] The route of administration in the product records is oral. The study is a dose-escalation and dose-optimization design, meaning participants receive different dose levels to find the safest effective dose.

What do the clinical trials show?

There is one clinical trial of EIK1004 BIS-tartrate in the registry. It is a Phase 1/2, open-label, multicenter study in participants with advanced solid tumors.^[1] The study is authorised but not yet recruiting. It plans to enroll 51 participants. The trial has two parts: Part 1 evaluates safety and tolerability to determine the MTD (or MAD) and RDE as monotherapy; Part 2 evaluates safety and tolerability of EIK1004 as monotherapy at the selected dose.^[1]

The primary outcomes are dose-limiting toxicities (DLTs) and adverse events (AEs). These measure how well the medicine is tolerated and what side effects occur. The trial does not list secondary outcomes such as tumor response or survival in the registry data provided.

The trial is open-label, meaning both participants and researchers know which treatment is being given. It is multicenter, so it takes place at more than one hospital or clinic. Participants with advanced solid tumors may be eligible, but the registry data does not give detailed inclusion criteria.

What side effects are known?

No supplementary sources on side effects were provided. The trial itself is designed to measure dose-limiting toxicities and adverse events, but no specific side effects are listed in the registry data.