Actively Recruiting
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
Led by Eikon Therapeutics · Updated on 2026-04-08
160
Participants Needed
10
Research Sites
162 weeks
Total Duration
On this page
Sponsors
E
Eikon Therapeutics
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older at the time of signing consent
- Life expectancy of at least 3 months
- Histologically or cytologically confirmed advanced (unresectable and/or metastatic) solid tumor
- For Part 1A: archival tumor tissue not older than 3 years is recommended
- For Part 1B and Part 2: locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor with archival tissue for confirmation
- In Part 1A: received and progressed after or intolerant to at least one standard treatment for advanced cancer with no alternative options
- Measurable disease at baseline by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and bone marrow function
You will not qualify if you...
- Has not recovered from prior anti-cancer therapy side effects to Grade 1 or baseline
- Prior treatment with Werner helicase inhibitor
- History of serious allergic reactions or hypersensitivity to study drugs or ingredients
- For Parts 1B and 2: immunodeficiency or use of chronic systemic steroids over 10 mg prednisone equivalent or other immunosuppressive therapy within 7 days before first dose
- Known additional progressing malignancy treated within past 3 years
- Active central nervous system metastases or carcinomatous meningitis unless stable for at least 4 weeks without steroids for 14 days prior
- Mean resting QTcF over 470 ms on ECG
- Active autoimmune disease requiring systemic treatment within past 2 years, except specified conditions
- History or current pneumonitis or interstitial lung disease requiring steroids
- Active tuberculosis
- Active infections requiring systemic therapy
AI-Screening
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Trial Site Locations
Total: 10 locations
1
Morristown Medical Center
Morristown, New Jersey, United States, 07960
Not Yet Recruiting
2
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York, United States, 10022
Not Yet Recruiting
3
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
4
GenesisCare North Shore (Oncology)
Saint Leonards, New South Wales, Australia
Not Yet Recruiting
5
Calvary Mater Newcastle Hospital
Waratah, New South Wales, Australia
Actively Recruiting
6
Grampians Health
Ballarat, Victoria, Australia
Actively Recruiting
7
Chris O'Brien Lifehouse (Sydney Cancer Centre)
Camperdown, Victoria, Australia
Actively Recruiting
8
Oncology Clinics Victoria (OCV) - Cabrini Brighton Hospital
Frankston, Victoria, Australia, 3199
Not Yet Recruiting
9
Peninsula and Southeast Oncology (PASO) Medical
Frankston, Victoria, Australia
Actively Recruiting
10
Health New Zealand
Wellington, New Zealand
Actively Recruiting
Research Team
A
Ana C Mamede, PharmD
CONTACT
K
Krishna Kaza
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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