Study on the Safety and Effects of IDE574 Therapy in Adults with Advanced Solid Tumors

Sponsor: IDEAYA Biosciences

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT07540572

Provider View

This clinical trial is testing a new drug, IDE574, to see if it is safe and effective for treating advanced solid tumors. The study will also explore how the drug works in the body, both on its own and in combination with another medication, fulvestrant, for certain types of breast cancer.

Patient Parameters

Program Overview

The study aims to evaluate the safety and initial effectiveness of a new drug called IDE574, which targets specific enzymes involved in cancer growth. It will be tested alone in patients with advanced solid tumors and in combination with fulvestrant in patients with advanced or metastatic estrogen receptor-positive (ER+), HER2-negative breast cancer. Researchers will assess how the drug is processed in the body and its impact on the cancer.

Description

The study is divided into two main parts:

Part 1 - Testing IDE574 Alone:

  • Part 1A: This phase will test increasing doses of IDE574 to find the safest and most effective dose for patients with advanced or metastatic ER+ HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite-stable colorectal cancer.
  • Part 1B: This phase will further test IDE574 at the identified safe dose in patients with advanced or metastatic ER+ HER2- breast cancer.

Part 2 - Testing IDE574 with Fulvestrant:

  • Part 2A: This phase will test increasing doses of IDE574 combined with fulvestrant in patients with advanced or metastatic ER+ HER2- breast cancer to find the safest and most effective dose.
  • Part 2B: This phase will further test the combination at the identified safe dose in patients with advanced or metastatic ER+ HER2- breast cancer.

Eligibility Criteria

Inclusion Criteria

  • Provide a previous tumor tissue sample for testing.
  • Part 1A: Have advanced or metastatic ER+ HER2- breast cancer, non-small cell lung cancer, castration-resistant prostate cancer, or microsatellite-stable colorectal cancer that has worsened after standard treatments or cannot tolerate more treatments.
  • Parts 1B, 2A, and 2B: Have advanced or metastatic ER+ HER2- breast cancer that has worsened after at least one prior treatment with hormone therapy and a CDK4/6 inhibitor.
  • Female participants with ER+ HER2- breast cancer who can have children must agree to undergo medically induced menopause (Parts 2A and B only).
  • Female participants who cannot have children must meet certain criteria, such as being over 60 years old or having had both ovaries removed.
  • Have a performance status score of 0 or 1, indicating full activity or some restriction in strenuous activities.
  • Have adequate bone marrow, kidney, and liver function.
  • Have a life expectancy of more than 3 months.
  • Be able to take the study drug by mouth and keep it down.
  • Agree to use effective birth control methods.

Exclusion Criteria

  • Have known brain metastases or cancer spread to the membranes covering the brain and spinal cord.
  • Have a primary cancer in the central nervous system or any other cancers within the last 2 years, except for certain localized tumors that were treated.
  • Have digestive issues that could affect the absorption of IDE574.
  • Have active liver or bile duct disease.
  • Have active, uncontrolled infections.
  • Have significant heart problems or blood clotting issues within the last 6 months.
  • Have not fully recovered from side effects of previous cancer treatments.
  • Have had radiation to more than 25% of the bone marrow.
  • Have known allergies to IDE574 or its components, or to fulvestrant or its components (Part 2 only).

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