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

Study Identifier:
IDE574-001
CT.gov Identifier:
NCT07540572
EudraCT Identifier:
N/A
EU Trial (CTIS) Number:
N/A
Study Contact Information:
N/A
Recruiting

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Study Summary

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.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
N/A
Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
I/II
Sex
N/A
Age
18 - 99 Years
Study Drug
  • Drug: EXPERIMENTAL: Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant
    • Read More
  • Drug: Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant
  • Drug: Drug: Fulvestrant injection
  • Drug: Fulvestrant Injection
  • Drug: Drug: IDE574
  • Drug: IDE574
  • Drug: EXPERIMENTAL: Combination Dose Expansion (Part 2B)
  • Drug: Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant
  • Drug: EXPERIMENTAL: Monotherapy Dose Escalation (Part 1A)
  • Drug: Participants with the appropriate tumor types will be treated with escalating doses of IDE574
  • Drug: EXPERIMENTAL: Monotherapy Dose Expansion (Part 1B)
  • Drug: Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruiting

    Requirements information
    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)

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START New Jersey
    East Brunswick, NJ, United States, 08816
    Investigator
    Bruno Fang
    Status
    Recruiting
    Condition(s) Treated at Site
    Location
    START Dallas Fort Worth
    Fort Worth, TX, United States, 76104
    Investigator
    Henry Xiong
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Location
    START San Antonio
    San Antonio, TX, United States, 78229
    Investigator
    Amita Patnaik
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Location
    START Mountain Region
    West Valley City, UT, United States, 84119
    Investigator
    William McKean
    Status
    Will Be Recruiting
    Condition(s) Treated at Site