Study on EIK1004 (IMP1707) for Treating Advanced Solid Tumors

Sponsor: Eikon Therapeutics

Sponsor score: 0

ClinicalTrials ID:NCT06907043

Provider View

This clinical trial is testing a new drug, EIK1004 (IMP1707), to see if it is safe and effective for patients with advanced breast, ovarian, prostate, and pancreatic cancers that have specific genetic mutations.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called EIK1004 (IMP1707) in patients with advanced or metastatic breast, ovarian, prostate, and pancreatic cancers. These cancers have specific genetic mutations that affect how cells repair themselves. The study is in two phases: Phase 1 will determine the safest dose, and Phase 2 will further test the drug's effects and how it works in the body.

Description

This study is designed to test the safety and effectiveness of EIK1004 (IMP1707) as a single treatment for patients with advanced solid tumors that have returned or spread. The study has two parts:

  1. Dose Escalation (Part 1): This part will find the highest dose of EIK1004 (IMP1707) that patients can tolerate without severe side effects.

  2. Dose Optimization (Part 2): This part will further explore the safety, how the drug moves and works in the body, and its ability to fight tumors at selected doses.

Eligibility Criteria

Inclusion Criteria

  • Patients with brain metastases that do not need immediate treatment.
  • Patients who have previously received treatment for brain metastases.

Exclusion Criteria

  • Have taken any experimental or approved cancer treatments within 28 days before starting EIK1004 (IMP1707).
  • Have used other drugs similar to EIK1004 (IMP1707) in the past.
  • Have certain heart conditions affecting the heart's electrical activity.
  • Have active hepatitis B or C infections.
  • Have a tendency to bleed easily.
  • Cannot swallow pills or have digestive issues that affect how the body absorbs medication.

Brain-Related Exclusion Criteria:

  • Have untreated brain tumors larger than 2 cm.
  • Need to use steroids for brain symptoms within 7 days before starting the study or need more than 10 mg of prednisone daily.
  • Have brain tumors that need immediate treatment, especially in critical areas like the brain stem.
  • Have symptoms of cancer spreading to the brain's lining.
  • Have poorly controlled seizures.

Locations

FACILITYZIPCITYSTATE
MD Anderson77030HoustonTexas

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