RecruitingPhase 1Phase 2NCT07262619

EIK1005-002: A Clinical Research Study Evaluating EIK1005, a Werner Helicase Inhibitor, as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors Including Microsatellite Instability High (MSI-H) Tumors

A Multicenter, Multi-Part, Phase 1/2 Study of EIK1005 as Monotherapy and in Combination With Pembrolizumab in Participants With Advanced Solid Tumors, Including Checkpoint Inhibitor Naïve Participants With Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) Tumors


Sponsor

Eikon Therapeutics

Enrollment

160 participants

Start Date

Jan 20, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to determine the most effective dose of EIK1005 that a person can take safely. Additionally, this study will test how well EIK1005 is tolerated alone and in combination with pembrolizumab in treating patients with advanced cancer.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing EIK1005 — a new drug that targets a protein called Werner Helicase involved in DNA repair — alone and in combination with pembrolizumab (an immunotherapy drug), in patients with advanced solid tumors, with a focus on tumors that have a specific instability in their DNA repair system called MSI-H or dMMR. **You may be eligible if...** - You are 18 or older - You have confirmed advanced (unresectable or metastatic) solid tumor cancer - Your life expectancy is at least 3 months - For some parts: your tumor has confirmed MSI-H or mismatch repair deficient (dMMR) status - You have archival tumor tissue available **You may NOT be eligible if...** - You have had prior treatment with pembrolizumab or similar drugs with severe adverse effects - You have significant immune system disorders or require immune-suppressing medications - Your organ function is below required thresholds Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEIK1005

EIK1005 is a selective inhibitor of the Werner helicase.

DRUGpembrolizumab (KEYTRUDA® )

Pembrolizumab is a PD-1 inhibitor.


Locations(10)

Morristown Medical Center

Morristown, New Jersey, United States

Memorial Sloan Kettering Cancer Center (MSKCC)

New York, New York, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

GenesisCare North Shore (Oncology)

Saint Leonards, New South Wales, Australia

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia

Grampians Health

Ballarat, Victoria, Australia

Chris O'Brien Lifehouse (Sydney Cancer Centre)

Camperdown, Victoria, Australia

Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital

Frankston, Victoria, Australia

Peninsula and Southeast Oncology (PASO) Medical

Frankston, Victoria, Australia

Health New Zealand

Wellington, New Zealand

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT07262619


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