Phase 1/2 Study of EIK1005 as Monotherapy & Combination with Pembrolizumab in Advanced Solid Tumours
Research type
Research Study
Full title
A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination with Pembrolizumab in Participants with Advanced Solid Tumors, including Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors
IRAS ID
1013678
Contact name
Ana Mamede
Contact email
Sponsor organisation
Eikon Therapeutics, Inc.
Clinicaltrials.gov Identifier
Research summary
EIK1005 is a possible treatment being developed for patients with advanced cancer. It targets Werner Syndrome helicase (WRN), an enzyme involved in a different DNA repair pathway, in cancer cells lacking DNA mismatch repair (dMMR) or having a high number of genetic errors (microsatellite instability-high [MSI-H]).
The goal of this Phase 1/2 clinical trial (EIK1005-002) is to determine the most effective dose of EIK1005 that a person can take safely. The study will test how well EIK1005 is tolerated alone (monotherapy) and in combination with pembrolizumab (approved immunotherapy drug for dMMR cancers or MSI), in treating patients with advanced cancer.
The study will investigate EIK1005 safety and tolerability, pharmacokinetics (PK; how well the drug is processed in the body), pharmacodynamics (PD; how the drug affects the body), and early signs of effectiveness.
It will be conducted in 2 parts: Parts 1 (A and B) and Part 2:
• Part 1A (monotherapy dose escalation): participants will receive EIK1005 only.
• Part 1B (combination dose escalation): participants will receive EIK1005 in combination with pembrolizumab.
• Part 2 (dose optimisation): participants will be randomised 1:1 to monotherapy with EIK1005 at one of the two selected doses from Part 1A, or EIK1005 in combination with pembrolizumab.REC name
Wales REC 3
REC reference
26/WA/0130
Date of REC Opinion
25 Jun 2026
REC opinion
Further Information Favourable Opinion