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IDE574 for Advanced Solid Tumors

This study is testing a drug called IDE574 in adults aged 18 to 99 with advanced solid tumors, including certain types of breast cancer (ER+, HER2-), non-small cell lung cancer, castration-resistant prostate cancer, and microsatellite stable colorectal cancer. You would have already received at least one standard treatment or be unable to tolerate more. The study will look at how safe IDE574 is, how your body handles it (pharmacokinetics), and if it shows early signs of shrinking tumors (preliminary efficacy). For some breast cancer patients, IDE574 will also be tested in combination with fulvestrant injection. Success will be measured by how safe the treatment is and how many patients see their tumors shrink or stop growing. We don't know the current status of recruitment for this study.

Study design
This is an interventional study planning to enroll 160 participants. It involves different parts, including testing IDE574 alone and in combination with fulvestrant.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and anti-tumor activity will be measured for approximately 24 months total study duration.

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NCT07540572

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

Recruiting
PHASE1Ages 18–99InterventionalTreatment
IDEAYA Biosciences
~160 participants
Updated 2026-06-16 on ClinicalTrials.gov
What's tested:IDE574Fulvestrant injection

At a glance

Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation
Measured over 21 days following the first dose of IDE574
+7 more outcomes measured

Conditions

ER+, HER 2- Breast Cancer
Non-small Cell Lung Cancer (NSCLC)
Castration-resistant Prostate Cancer (CRPC)
Microsatellite Stable (MSS) Colorectal Carcinoma

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Where it's being run

11 sites across 6 states
Texas6
Florida1
New Jersey1
New York1
Utah1
Virginia1

Who to contact

IDEAYA Clinical Trials
[email protected]
+1-855-433-224
Email the study team

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Eligibility criteria

Inclusion

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

Exclusion

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)

What this trial measures

  • Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation21 days following the first dose of IDE574

    incidence of DLT; incidence and severity of AEs/serious adverse events (SAEs) graded based on CTCAE V6.0

  • Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEsApproximately 24 months total study duration

    Incidence and severity of AEs/SAEs graded based on CTCAE V6.0

  • To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1Approximately 24 months total study duration

    Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response

  • To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.Approximately 24 months total study duration

    Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response

  • Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLTApproximately 24 months total study duration

    Incidence of DLT; incidence and severity of AEs/SAEs graded based on CTCAE V6.0

  • Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the incidence and severity of AEs/SAEsApproximately 24 months total study duration

    Incidence and severity of AEs/SAEs graded based on CTCAE V6.0

  • Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the ORR per RECIST version 1.1Time Frame: Approximately 24 months total study duration

    Objective Response Rate (ORR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response

  • Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on DOR per RECIST version 1.1.Time Frame: Approximately 24 months total study duration

    Duration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response