EIK1005 for Advanced Solid Tumors, Alone or With Pembrolizumab

This study is testing a new drug called EIK1005, both by itself and in combination with pembrolizumab (KEYTRUDA®), for people with advanced solid tumors. EIK1005 works by targeting a specific protein called Werner helicase. Pembrolizumab is a type of immunotherapy. The main goals are to find the safest and most effective dose of EIK1005, and to see how well it is tolerated and if it helps treat advanced cancers, especially those with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). You may be eligible if you are at least 18 years old, have advanced solid tumors, and a life expectancy of at least 3 months. The study is currently unclear on its recruitment status.

Study design
This is a Phase 1/2 study with a planned enrollment of 160 participants. It has different parts where participants receive EIK1005 alone or with pembrolizumab, and some parts involve randomization.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Adverse events will be monitored for 30 days after stopping study treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07262619

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Eikon Therapeutics
~160 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:EIK1005pembrolizumab (KEYTRUDA® )

At a glance

Recruiting sites
6 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose-Limiting Toxicity (DLT) - Part 1
Measured over 21 Days
+1 more outcome measured
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
10 sites across 6 states
Victoria4
New South Wales2
New Jersey1
New York1
Texas1
New Zealand1
  • Nilou Mobashery, MD · STUDY_DIRECTOR · Eikon Therapeutics, Inc.

Opens a ready-to-send draft in your own email app — review before sending.

  • Dose-Limiting Toxicity (DLT) - Part 121 Days

    A DLT is a protocol-defined adverse event occurring during the DLT observation period.

  • Adverse Events (AEs) - Part 1 and Part 2From the time of first dose of study medication through 30 days following cessation of study treatment.

    Number of participants reporting adverse events or serious adverse events.