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
Eikon Therapeutics
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.
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 on…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Key Inclusion Criteria: 1. is ≥ 18 years of age at the time of signing the informed consent. 2. has a life expectancy of at least 3 months. 3. has histologically or cytologically documented advanced (unresectable and/or metastatic) solid tumor. Part 1A: recommend that participants have archival tissue not more than 3 years old. Part 1B and Part 2: participant has locally confirmed Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumor. Participant must have archival tumor tissue (not more than 3 years old) for retrospective confirmation of MSI-H or dMMR tumor by a c…
Interventions
- DrugEIK1005
EIK1005 is a selective inhibitor of the Werner helicase.
- Drugpembrolizumab (KEYTRUDA® )
Pembrolizumab is a PD-1 inhibitor.
Locations (10)
- Morristown Medical CenterMorristown, New Jersey
- Memorial Sloan Kettering Cancer Center (MSKCC)New York, New York
- University of Texas MD Anderson Cancer CenterHouston, Texas
- GenesisCare North Shore (Oncology)Saint Leonards, New South Wales
- Calvary Mater Newcastle HospitalWaratah, New South Wales
- Grampians HealthBallarat, Victoria