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

Part of paid clinical trials in Morristown, New Jersey.

Sponsor
Eikon Therapeutics
Study ID
NCT07262619
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Solid Tumors
  • Endometrial Cancer
  • MSI-H or dMMR Advanced Solid Tumors
  • MSI-H/dMMR Colorectal Cancer
  • MSI-H/dMMR Gastric Cancer
  • MSI-H/dMMR Gastroesophageal-junction Cancer
  • Mismatch Repair Deficient or MSI-High Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • EIK1005 — DRUG
    EIK1005 is a selective inhibitor of the Werner helicase.
  • pembrolizumab (KEYTRUDA® ) — DRUG
    Pembrolizumab is a PD-1 inhibitor.

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Apr 2026
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1A (Dose escalation, Monotherapy)
    EIK1005 will be given as monotherapy in participants without alternative treatment options.
  • Experimental: Part 1B (Dose escalation, Combination with pembrolizumab)
    EIK1005 will be given in combination with pembrolizumab to participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) solid tumors.
  • Experimental: Part 2 (Dose optimization, Monotherapy)
    Participants with Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced solid tumors will be randomized to receive EIK1005 monotherapy at one of the two identified doses selected from Part 1A.

Primary Outcome Measure

Dose-Limiting Toxicity (DLT) - Part 1 [ Time Frame: 21 Days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Morristown Medical CenterMorristownNew Jersey07960-
Memorial Sloan Kettering Cancer Center (MSKCC)New YorkNew York10022-
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Morristown, NJ

By condition
Endometrial cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Morristown Medical Center· Morristown, NJMemorial Sloan Kettering Cancer Center (MSKCC)· New York, NYUniversity of Texas MD Anderson Cancer Center· Houston, TX

Related Studies