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New drug IDE574 enters human trials for Hard-to-Treat cancers

NCT ID NCT07540572

Disease control Sponsor: IDEAYA Biosciences Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called IDE574 in people with advanced solid tumors or a specific type of breast cancer (ER+, HER2-). The drug targets two enzymes that help cancer cells grow. The study has two parts: first, testing IDE574 alone in various cancers; second, combining it with another drug (fulvestrant) for breast cancer. About 160 participants will join to check safety, side effects, and whether the drug shrinks tumors.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 160 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Jun 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

castration-resistant prostate carcinoma colorectal adenocarcinoma colorectal carcinoma colorectal neoplasm estrogen-receptor positive breast cancer non-small cell lung carcinoma Spinocerebellar Degenerations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Castration-resistant prostate cancer (CRPC) ER+, HER 2- breast cancer Microsatellite stable (MSS) colorectal carcinoma Non-small cell lung cancer (NSCLC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    11 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida Clinical Trials Group

    RECRUITING

    Plantation, Florida, 33322, United States

  • NEXT Texas LLC - Austin

    RECRUITING

    Austin, Texas, 78758, United States

  • NEXT Texas LLC - Dallas

    RECRUITING

    Dallas, Texas, 75039, United States

  • NEXT Texas LLC - Houston

    RECRUITING

    Houston, Texas, 77054, United States

  • NEXT Texas LLC - San Antonio

    RECRUITING

    San Antonio, Texas, 78229, United States

  • NEXT Virginia

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • START Astera, LLC

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

    Contact Email: •••••@•••••

  • START Dallas Fort Worth, LLC

    RECRUITING

    Fort Worth, Texas, 76104, United States

    Contact Email: •••••@•••••

  • START Mountain Region, LLC

    RECRUITING

    West Valley City, Utah, 84119, United States

    Contact Email: •••••@•••••

  • START New York Long Island, LLC

    RECRUITING

    Lake Success, New York, 11042, United States

    Contact Email: •••••@•••••

  • Start San Antonio, LLC

    RECRUITING

    San Antonio, Texas, 78229, United States

    Contact Email: •••••@•••••

More trials for these conditions

Other studies related to the condition(s) this trial covers.