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

NCT07540572 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: IDE574-001178299
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

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

Keywords

ER+, HER 2- Breast Cancer; Non-small Cell Lung Cancer (NSCLC); Castration-resistant Prostate Cancer (CRPC); Microsatellite Stable (MSS) Colorectal Carcinoma; KAT6A/B; KAT7

Outcome Measures

Primary Outcomes (8)

• 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

  21 days following the first dose of IDE574

• 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

  Approximately 24 months total study duration

• To evaluate anti-tumor activity of IDE574 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

  Approximately 24 months total study duration

• To evaluate anti-tumor activity of IDE574 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

  Approximately 24 months total study duration

• 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

  Approximately 24 months total study duration

• 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

  Approximately 24 months total study duration

• 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

  Time Frame: Approximately 24 months total study duration

• 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

  Time Frame: Approximately 24 months total study duration

Secondary Outcomes (30)

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

  Approximately 24 months total study duration

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

  Approximately 24 months total study duration

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

  Approximately 24 months total study duration

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

  Approximately 24 months total study duration

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

  Approximately 24 months total study duration

Study Arms (4)

Monotherapy Dose Escalation (Part 1A)

EXPERIMENTAL

Participants with the appropriate tumor types will be treated with escalating doses of IDE574

Drug: IDE574

Monotherapy Dose Expansion (Part 1B)

EXPERIMENTAL

Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen monotherapy dose(s) of IDE574

Drug: IDE574

Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant

EXPERIMENTAL

Participants with ER+ HER2- advanced or metastatic breast cancer will be treated with escalating doses of IDE574 in combination with fulvestrant

Drug: IDE574; Drug: Fulvestrant injection

Combination Dose Expansion (Part 2B)

EXPERIMENTAL

Participants with ER+ HER2- advanced or metastatic breast cancer will be treated using the chosen combination dose(s) of IDE574 + Fulvestrant

Drug: IDE574; Drug: Fulvestrant injection

Interventions

IDE574 DRUG

IDE574

Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant; Combination Dose Expansion (Part 2B); Monotherapy Dose Escalation (Part 1A); Monotherapy Dose Expansion (Part 1B)

Fulvestrant injection DRUG

Fulvestrant Injection

Combination Dose Escalation (Part 2A) IDE574 + Fulvestrant; Combination Dose Expansion (Part 2B)

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• IDEAYA Biosciences: lead

Study Sites (6)

START NY

Lake Success, New York, 11042, United States

ACTIVE NOT RECRUITING

NEXT Texas LLC - Austin

Austin, Texas, 78758, United States

RECRUITING

NEXT Texas LLC - Dallas

Dallas, Texas, 75039, United States

RECRUITING

NEXT Texas LLC - Houston

Houston, Texas, 77054, United States

RECRUITING

NEXT Texas LLC - San Antonio

San Antonio, Texas, 78229, United States

RECRUITING

Start San Antonio, LLC

San Antonio, Texas, 78229, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Spinocerebellar Degenerations; Colorectal Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Cerebellar Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Spinal Cord Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 20, 2026
• Study Start: March 17, 2026
• Primary Completion (Estimated): March 30, 2030
• Study Completion (Estimated): June 30, 2030
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)