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CancerPhase 1NCT07540572

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

A Phase 1 study testing IDE574 and Fulvestrant injection in people with Cancer, run by IDEAYA Biosciences at 23 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Cancer
What is being tested?
IDE574 and Fulvestrant injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
23 sitesin 2 countries
Study dates
17 Mar 2026to 31 Jan 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • Life expectancy of >3 months
  • Able to safely administer and retain orally administered study treatment
  • Able to comply with contraceptive/barrier requirements

Who cannot join

  • 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
Show all 9Show fewer
  • 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)

Trial locations and contacts

23 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

IDEAYA Clinical Trials contact

+1-855-433-224

IDEAYAClinicalTrials@ideayabio.com

23 sites in 2 countries

United States18 sites, 16 recruiting

  • Winship Cancer Institute, Emory University

    Atlanta, Georgia, 30322-1013

    Alejandra Bono, 404-778-0954, alejandra.maria.bono@emory.edu

    Shipra Gandhi, MD

    Recruiting

  • NEXT Texas LLC - Austin

    Austin, Texas, 78758

    Heather Watson, 737-610-5202, nxtaus_coordinators@nextoncology.com

    Sheena Sahota, MD

    Recruiting

  • NEXT Texas LLC - Dallas

    Dallas, Texas, 75039

    Carmen Gonzalez, 210-580-9479, NXTDFW_Coordinators@nextoncology.com

    Faran Polani, MD

    Recruiting

  • START Astera, LLC

    East Brunswick, New Jersey, 08816

    Bruno S Fang, 732-426-4750, info@startresearch.com

    Bruno Fang, MD

    Recruiting

  • NEXT Virginia

    Fairfax, Virginia, 22031

    Maybelle De La Rosa, 703-783-4518, nxtvir_coordinators@nextoncology.com

    Mohamad Salkeni, MD

    Recruiting

  • START Dallas Fort Worth, LLC

    Fort Worth, Texas, 76104

    Henry Xiong, 682-350-3010, info@startresearch.com

    Henry Xiong, MD

    Recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

    Desirae Dufner, 713-524-3434, DDufner@mdanderson.org

    Timothy Yap, MD

    Recruiting

  • NEXT Texas LLC - Houston

    Houston, Texas, 77054

    Carmen Gonzalez, 210-580-9479, nxthou_coordinators@nextoncology.com

    Jennifer Segar, MD

    Recruiting

  • START New York Long Island, LLC

    Lake Success, New York, 11042

    Geraldine O'Sullivan Coyne, 363-207-5160, g.osullivancoyne@startresearch.com

    Geraldine O'Sullivan Coyne, MD

    Recruiting

  • SCRI Oncology Partners - PPDS

    Nashville, Tennessee, 37203

    Connor Frost, 615-478-3475, connor.frost@scri.com

    Sarah Premji, MD

    Recruiting

  • Yale School of Medicine - Cedar Street

    New Haven, Connecticut, 06510-3206

    Karen Seely, 203-314-3303, karen.rodriguezvasquez@yale.edu

    Patricia LoRusso, MD

    Recruiting

  • Columbia University Medical Center -161 Fort Washington

    New York, New York, 10032-3729

    Active, not recruiting

  • Florida Clinical Trials Group

    Plantation, Florida, 33322

    Sandra Perez, 772-297-3057, perezs@floridactg.com

    Harshad Amin, MD

    Recruiting

  • NEXT Texas LLC - San Antonio

    San Antonio, Texas, 78229

    April Guerra, 210-580-9500, NXTSA_Coordinators@nextoncology.com

    David Sommerhalder, MD

    Recruiting

  • Start San Antonio, LLC

    San Antonio, Texas, 78229

    Hector Navarro, 210-593-5700, Hector.Navarro@startresearch.com

    Amita Patnaik, MD

    Recruiting

  • UCLA - Parkside Cancer Center

    Santa Monica, California, 90404-2095

    Active, not recruiting

  • Washington University - Siteman Cancer Center

    St Louis, Missouri, 63110-1010

    Pamela Coe, 314-747-7569, mpamela@wustl.edu

    Faisal Fa'ak, MD

    Recruiting

  • START Mountain Region, LLC

    West Valley City, Utah, 84119

    William B McKean, 1 (801) 907-4750, info@startresearch.com

    William McKean, MD

    Recruiting

Other trials in United States

Georgia5 sites, 2 recruiting

  • High Technology Hospital MedCenter Ltd

    Batumi, K'alak'i T'bilisi, 6000

    Mamuka Sikharulidze, +995 568 999 559, sikharulidzemamuka3@gmail.com

    Tamta Makharadze, MD

    Recruiting

  • LLC ARENSIA Exploratory Medicine

    Tbilisi, K'alak'i T'bilisi, 112

    Active, not recruiting

  • Pineo Medical Ecosystem

    Tbilisi, K'alak'i T'bilisi, 114

    Nino Kekenadze, +995 593 660 940, Nkekenadze@pineo.ge

    Mziuri Zakaraia, MD

    Recruiting

  • Geo Hospitals Multiprofile Medical Center Tbilisi

    Tbilisi, K'alak'i T'bilisi, 144

    Active, not recruiting

  • LLC Caucasus Medical Centre

    Tbilisi, K'alak'i T'bilisi, 186

    Active, not recruiting

Other trials in Georgia

About this study

Official title: 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 Cancer

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 cancer.

Read the detailed description

Part 1 - Monotherapy Dose Escalation and Expansion:

Part 1A - Monotherapy Dose Escalation Part 1A will evaluate increasing doses of IDE574 to assess safety, tolerability and to determine dose-limiting toxicities (DLTs), the maximum tolerated dose (MTD) or the recommended dose for expansion (RDE) in subjects with advanced or metastatic cancer.

Part 1B - Monotherapy Dose Expansion Part 1B will evaluate in ER+ HER2- advanced or metastatic cancer at one RDE determined from Part 1A or the MTD.

Part 1C - Exploratory Food Effect Sub-study

Part 2 - Combination Dose Escalation and Expansion

Part 2A - IDE574 Combination Therapy with Fulvestrant Dose Escalation Part 2A will evaluate participants with advanced or metastatic cancer with escalating doses of IDE574 in combination with fulvestrant to assess safety, tolerability and to determine DLTs, MTD or RDE.

Part 2B - IDE574 Combination Therapy with Fulvestrant Dose Expansion Part 2B will randomly assign participants with advanced or metastatic cancer to dose levels selected from Part 2A

Conditions
Cancer
Being tested
IDE574, Fulvestrant injection
Keywords
KAT6A/B, KAT7
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IDE574Drug

    IDE574

  • Fulvestrant injectionDrug

    Fulvestrant Injection

Study groups in NCT07540572
Study groupRoleWhat they receive
Monotherapy Dose Escalation (Part 1A)ExperimentalParticipants with the appropriate tumor types will be treated with escalating doses of IDE574
Receives: Drug: IDE574
Monotherapy Dose Expansion (Part 1B)ExperimentalParticipants with advanced or metastatic cancer will be treated using the RDE or MTD of IDE574
Receives: Drug: IDE574
Combination Dose Escalation (Part 2A) IDE574 + FulvestrantExperimentalParticipants with advanced or metastatic cancer will be treated with escalating doses of IDE574 in combination with fulvestrant
Receives: Drug: IDE574; Drug: Fulvestrant injection
Combination Dose Expansion (Part 2B)ExperimentalParticipants with advanced or metastatic cancer will be randomly assigned to doses of IDE574 + Fulvestrant
Receives: Drug: IDE574; Drug: Fulvestrant injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation

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

    Measured: Following the first dose of IDE574

  2. Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs

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

    Measured: total study duration

  3. To evaluate anti-tumor activity of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1

    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

    Measured: total study duration

  4. To evaluate anti-tumor activity of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.

    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

    Measured: total study duration

  5. Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT

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

    Measured: total study duration

  6. Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the incidence and severity of AEs/SAEs

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

    Measured: total study duration

  7. Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on the ORR per RECIST version 1.1

    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

    Measured: total study duration

  8. Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on DOR per RECIST version 1.1.

    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

    Measured: total study duration

Secondary outcomes (14)

  1. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on the ORR per RECIST version 1.1

    Measured: total study duration

  2. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on DOR per RECIST version 1.1.

    Measured: total study duration

  3. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Clinical Benefit Rate (CBR)

    Measured: total study duration

  4. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Disease control rate

    Measured: total study duration

  5. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation

    Measured: total study duration

  6. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion

    Measured: total study duration

  7. Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion

    Measured: total study duration

  8. Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion based on DCR for other solid tumor types

    Measured: total study duration

  9. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on ORR per RECIST version 1.1

    Measured: total study duration

  10. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on DOR per RECIST version 1.1

    Measured: total study duration

  11. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on CBR per RECIST version 1.1

    Measured: total study duration

  12. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation

    Measured: total study duration

  13. Evaluate antitumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on CBR per RECIST version 1.1

    Measured: total study duration

  14. Evaluate the PK of IDE574 in Part 2B Combination Dose Expansion

    Measured: total study duration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start17 Mar 2026
  3. Primary completion31 Dec 2029 (estimated)
  4. Study completion31 Jan 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07540572
Sponsor's protocol ID
IDE574-001
Other IDs
178299
Status last verified
Nov 2026
First submitted
1 Apr 2026
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing IDE574 and Fulvestrant injection in people with Cancer, run by IDEAYA Biosciences at 23 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Georgia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact IDEAYA Clinical Trials (+1-855-433-224, IDEAYAClinicalTrials@ideayabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation (time frame: Following the first dose of IDE574). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07540572.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2026.

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