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
Start Date
1/20/2026
Completion Date
3/1/2029
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.
Detailed Description
This Phase 1/2 study (EIK1005-002) will investigate the safety and tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and preliminary clinical activity of EIK1005 as a 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. The study will be conducted in 2 parts: Part 1 and Part 2, with Part 1 being further divided into Part 1A and Part 1B as described below: * 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 optimization): participants will be randomized 1:1 to monotherapy with EIK1005 at one of the two selected doses from Part 1A to identify the dose of EIK1005 in monotherapy for subsequent studies.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
EIK1005
pembrolizumab (KEYTRUDA® )
Conditions
Locations
California Research Institute (CRI)
Los Angeles, California 90027
United States
Omnicure Clinical Research
Doral, Florida 33172
United States
Bioresearch Partner
Hialeah, Florida 33013
United States
Florida Clinical Trials Group
Plantation, Florida 33322
United States
Florida Clinical Trials Group - Tamarac
Tamarac, Florida 33321
United States
Morristown Medical Center
Morristown, New Jersey 07960
United States
START New York-Long Island
Lake Success, New York 11042
United States
Memorial Sloan Kettering Cancer Center (MSKCC)
New York, New York 10022
United States
START Dallas Fort Worth
Fort Worth, Texas 76104
United States
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
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 3199
Australia
Peninsula and Southeast Oncology (PASO) Medical
Frankston, Victoria
Australia
Ordensklinikum Linz Elisabethinen
Linz, 4020
Austria
Centre Hospitalier Universitaire Brugmann - Victor Horta
Brussels, 1020
Belgium
Kuopio University Hospital
Kuopio, 70210
Finland
Norddeutsches Studienzentrum fur Innovative Onkologie (NIO) Hamatologisch Onkologische Praxis Eppendorf (HOPE)
Hamburg, 22297
Germany
Campus Bio-Medico di Rome University
Rome, 00128
Italy
Palmerstone North Hospital
Roslyn, Manawatu 4414
New Zealand
Health New Zealand
Wellington,
New Zealand
Oslo University
Oslo, 0379
Norway
One Day Med
Szczecin, West Pomeranian Voivodeship 70-419
Poland
GCPMED Sp. z o.o., Centrum Medyczne iMed24
Krakow, 31-864
Poland
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Spolka Komandytowo-Akcyjna
Lodz, 90-338
Poland
Hospital de Santa Maria
Lisbon, 1649-028
Portugal
Unidade Local de Saúde (ULS) Loures Odivelas
Loures, 2674-514
Portugal
National Cancer Centre Singapore (NCCS)
Singapore, Central Region 168583
Singapore
Ajou University School of Medicine & Graduate School of Medicine
Suwon, 16499
South Korea
START - Barcelona
Barcelona, 08023
Spain
START Rioja - Hospital de San Pedro
Logroño, 26006
Spain
NEXT Madrid HUQSM
Madrid, 28233
Spain
Hospital Universitario Miguel Servet
Zaragoza, 50009
Spain