IDE574 for adults with advanced solid tumors: safety and early activity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1/2 study uses a dose-escalation then expansion design to test IDE574 as a single agent and in combination with fulvestrant for ER+, HER2- breast cancer. Part 1A escalates IDE574 doses to find dose-limiting toxicities, a maximum tolerated dose or a recommended dose for expansion, with Part 1B expanding selected cohorts including an ER+ breast cancer expansion and optional basket cohorts for other tumor types. Part 2 repeats dose escalation and expansion of IDE574 given with fulvestrant specifically in ER+, HER2- breast cancer. The trial includes PK and PD sampling, requires archival tumor tissue, and enrolls patients who have progressed after prior standard therapies.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Archival Tissue sample for testing

* Part 1A - Participants with advanced or metastatic cancer who have progressed on/after standard of care therapy or are intolerant to additional effective therapies.
* Female participants with 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 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)

Where it's running

• Yale School of Medicine - Cedar Street
  New Haven, Connecticut, United States Recruiting
• Florida Clinical Trials Group
  Plantation, Florida, United States Recruiting
• Winship Cancer Institute, Emory University
  Atlanta, Georgia, United States Recruiting
• Washington University - Siteman Cancer Center
  St Louis, Missouri, United States Recruiting
• START Astera, LLC
  East Brunswick, New Jersey, United States Recruiting
• START New York Long Island, LLC
  Lake Success, New York, United States Recruiting

Study contacts

• Study coordinator: IDEAYA Clinical Trials
• Email: IDEAYAClinicalTrials@ideayabio.com
• Phone: +1-855-433-224

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.