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

StatusRecruiting
PhasePhase 1/2
Started

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Record History

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  1. Trial sites expanded: 10 → 35 locations Show 4 more changesShow less
    • Eligibility criteria expanded, about 18 words
    • Secondary endpoints: details revised at 2 of 9 entries
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  2. Start date: Jan 22, 2026 to Jan 20, 2026
    • Site details revised at 3 of 10 sites
    v3
  3. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 8 to 10
    • Start date changed from estimate of Dec 2025 to Jan 22, 2026
    • Interventions: EIK1005 (Drug), Pembrolizumab (KEYTRUDA® ) (Drug) to EIK1005 (Drug), pembrolizumab (KEYTRUDA® ) (Drug)
    • Collaborators expanded, about 5 words
  4. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07262619
Lead Sponsor Eikon Therapeutics
Collaborators: Merck Sharp & Dohme LLC
Conditions
(from sponsor)		 Advanced Solid Tumors, MSI-H or dMMR Advanced Solid Tumors, MSI-H/dMMR Gastric Cancer, MSI-H/dMMR Colorectal Cancer, MSI-H/dMMR Gastroesophageal-junction Cancer, Endometrial Cancer, Mismatch Repair Deficient or MSI-High Solid Tumors
Related terms Endometrial Neoplasms, Neoplasm Metastasis, Turcot syndrome
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov