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

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Eikon Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• 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

Interventions

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

Timeline

• Start date: 2026-01-20
• Primary completion: 2029-03-01
• Completion: 2029-03-01
• First posted: 2025-12-03
• Last updated: 2026-04-08

Locations

10 sites across 3 countries: United States, Australia, New Zealand

Regulatory

• FDA-regulated drug study