No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
160 (estimated)
Sponsor
IDEAYA Biosciences · Industry
Who this trial is looking for
This trial is looking for adults with advanced solid tumors such as breast cancer, lung cancer, prostate cancer, or colorectal cancer. Participants will receive IDE574, either alone or with another treatment, and will be monitored for safety and effectiveness.
Are You a Good Fit for This Trial?
You may be able to join if
I have advanced or metastatic breast cancer, lung cancer, prostate cancer, or colorectal cancer.
I have had at least one previous treatment that didn’t work or I can’t have more effective therapies.
I have an archival tissue sample available for testing.
I can safely take oral medication.
I am at least 18 years old.
I have good bone marrow, kidney, and liver function.
My life expectancy is longer than 3 months.
I can follow contraceptive requirements if needed.
You may not be able to join if
I have known brain metastases or other active brain cancers.
I have had another type of cancer in the past 2 years, except for treated local tumors.
I have problems with my digestive system that would affect how well I absorb medication.
I have active liver disease.
I have uncontrolled infections.
I have serious heart issues or blood clotting problems in the last 6 months.
I have had severe reactions to previous cancer treatments that haven't completely healed.
I have had radiation to more than 25% of my bone marrow.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 partic…
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.
Trial Locations
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City
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Status
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 …
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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