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RecruitingPhase 1

A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors

An Open Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of IDE574 as Monotherapy in Locally Advanced or Metastatic Solid Tumors and as Combination Therapy With Fulvestrant in Locally Advanced or Metastatic ER+, HER2- Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests IDE574 in adults with solid tumors that have grown nearby or spread to other parts of the body. It tests IDE574 alone and with fulvestrant for ER-positive, HER2-negative breast cancer, which uses estrogen to grow and does not have high levels of HER2 protein. Researchers will check safety, early signs that treatment works, and how the drug moves through and affects the body.

IDE574 is a synthetically manufactured small molecule inhibitor that co-targets the lysine acetyltransferase enzymes KAT6 and KAT7. The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in participants with locally advanced or metastatic solid tumors and as combination therapy with fulvestrant in participants with advanced or metastatic ER+, HER2- breast cancer.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a stored tumor tissue sample available for testing.
  • Part 1A: Have advanced or spreading ER-positive, HER2-negative breast cancer, non-small cell lung cancer, prostate cancer that resists hormone-lowering treatment, or MSS colorectal adenocarcinoma (a bowel cancer without certain DNA repair changes). Cancer must have worsened during or after at least one standard treatment, or you cannot tolerate more effective treatments.
  • Parts 1B, 2A, and 2B: Have ER-positive, HER2-negative breast cancer that worsened after at least one treatment with hormone therapy and a CDK4/6 inhibitor, a drug that blocks cancer cell growth.
  • Parts 2A and 2B: Women with this breast cancer who could become pregnant, including those who only had their tubes tied, must agree to medicine that causes menopause.
  • Women with this breast cancer who cannot become pregnant must be at least 60, be under 60 with no periods for at least 12 months, or have had both ovaries removed.
  • Be fully active or able to do light work despite some limits on hard physical activity. Have bone marrow, kidneys, and liver that work well enough.
  • Be expected to live more than 3 months.
  • Be able to safely take and keep down the study drug by mouth, and follow the birth control and barrier protection rules.

Who can't join

  • Have cancer that has spread to the brain and causes symptoms, or cancer that has spread to the tissues around the brain and spinal cord.
  • Have cancer that started in the brain or spinal cord, or another cancer within 2 years before the first dose, except a local tumor that was adequately treated.
  • Have stomach or bowel problems that could greatly change how your body absorbs IDE574.
  • Have active liver or bile duct disease, or an active infection caused by bacteria, fungi, or viruses that is not controlled.
  • Have serious heart problems or blood clots within 6 months before the first dose.
  • Still have side effects worse than mild from an earlier experimental cancer treatment.
  • Have had radiation to more than 25% of your bone marrow, the tissue inside bones that makes blood cells.
  • Have a known or suspected allergy to IDE574 or its ingredients. In Part 2, this also includes an allergy to fulvestrant or its ingredients.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Archival Tissue sample for testing * Part 1A - Participants with advanced or metastatic ER+, HER2- breast cancer, NSCLC, CRPC, and MSS colorectal adenocarcinoma who have progressed on/after at least one line of standard of care therapy or are intolerant to additional effective therapies. * Parts 1B, 2A and 2B: Participants with ER+, HER2- breast cancer who have progressed after at least 1 prior line of treatment with an endocrine therapy and a CDK4/6 inhibitor * Female participants with ER+, HER2- breast cancer considered to be of childbearing potential (or have tubal ligations only) must be willing to undergo medically induced menopause (Parts 2A and B only) * Female participants of nonchildbearing potential with ER+, HER2- breast cancer must meet at least 1 of the following criteria: Age ≥ 60 years or age \<60 years with absence of menstruation for at least 12 months, or had prior removal of both ovaries * Have Eastern Cooperative Oncology Group performance status (ECOG PS) of ≤1. * Have adequate bone marrow, renal and liver function. * Life expectancy of \>3 months * Able to safely administer and retain orally administered study treatment * Able to comply with contraceptive/barrier requirements Key Exclusion Criteria: * Known symptomatic brain metastases or leptomeningeal metastasis * Known primary CNS malignancy and any other malignancies within 2 years prior to the first dose with the exception of adequately treated localized tumor. * Have impairment of GI function or GI disease that may significantly alter the absorption of IDE574. * Have active liver or biliary disease. * Have active, uncontrolled bacterial, fungal, or viral infection * Have clinically significant cardiac abnormalities and/or blood clotting events within 6 months before the first dose * If participants had adverse reactions to previous experimental antitumor treatment that have not recovered to Grade ≤ 1 * Prior irradiation to \>25% of the bone marrow. * Known or suspected hypersensitivity to IDE574/excipients or components (Parts 1 \& 2) or fulvestrant/excipients or components (Part 2 only)

Study sites (11)

FL

NJ

NY

TX

UT

VA