Study on EIK1005 Alone and with Pembrolizumab for Advanced Solid Tumors, Including MSI-H Tumors

Sponsor: Eikon Therapeutics

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07262619

Provider View

This clinical trial is testing a new drug, EIK1005, both by itself and with another drug, pembrolizumab, to find the safest and most effective dose for treating advanced cancers, including those with specific genetic features called MSI-H.

Patient Parameters

Program Overview

The purpose of this study is to find the safest and most effective dose of a new drug called EIK1005 for treating advanced solid tumors. The study will also test how well EIK1005 works alone and in combination with pembrolizumab, a drug used in cancer treatment. This trial is for patients with advanced cancers, including those with a genetic feature known as Microsatellite Instability High (MSI-H) or Mismatch Repair Deficient (dMMR) tumors.

Description

This study is divided into two parts. In Part 1, researchers will test EIK1005 alone (Part 1A) and then in combination with pembrolizumab (Part 1B) to find the best dose. In Part 2, participants will be randomly assigned to receive one of the two doses of EIK1005 identified in Part 1A to determine the best dose for future studies. The study will look at how safe and tolerable EIK1005 is, how it moves through the body, and its effects on the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a life expectancy of at least 3 months.
  • Have advanced solid tumors that cannot be removed by surgery or have spread to other parts of the body.
  • For Part 1A, must have tried at least one standard treatment and either not responded or cannot tolerate it. For Part 1B and Part 2, must have MSI-H or dMMR tumors confirmed by a lab test.
  • Have measurable disease based on specific medical criteria.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate organ and bone marrow function.

Exclusion Criteria

  • Have not fully recovered from side effects of previous cancer treatments.
  • Have previously been treated with a Werner Helicase inhibitor.
  • Have a history of severe allergic reactions to similar drugs.
  • Have an immune system deficiency or are taking high doses of steroids or other immune-suppressing drugs.
  • Have another active cancer that has required treatment in the past 3 years.
  • Have active cancer spread to the brain or spinal cord, unless stable and not requiring steroids.
  • Have a specific heart condition shown by an ECG test.
  • Have an active autoimmune disease needing treatment in the past 2 years, except for certain conditions like Type 1 diabetes or stable thyroid issues.
  • Have a history of lung inflammation requiring steroids or current lung disease.
  • Have active tuberculosis or other infections needing treatment.

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