> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-study-to-investigate-the-safety-pharmacokinetics-and-9b687821-79ba-4dca-8278-8dd2ba5046dc > Record changed: 2026-10-13 # A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors NCT07540572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Phase Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Participants 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Lead sponsor IDEAYA Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Start date 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) Number of sites 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Short title** A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **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 ER+, HER2- Breast Cancer Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Phase** Phase 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Dates **Completion date** 2030-06-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **First posted** 2026-04-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Registry last updated** 2026-06-16 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Primary completion date** 2030-03-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Start date** 2026-03-17 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Size and sites **Participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Planned participants** 160 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Protocol amendments** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Number of sites** 11 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Sponsor and oversight **Data monitoring committee** Yes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Lead sponsor** IDEAYA Biosciences Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Identifiers **Registry ID** NCT07540572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **ClinicalTrials.gov ID** NCT07540572 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Study design **Allocation** Not randomised **Model** Parallel groups **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Outcomes ### Primary outcomes 1. Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation Timeframe: 21 days following the first dose of IDE574 incidence of DLT; incidence and severity of AEs/serious adverse events (SAEs) graded based on CTCAE V6.0 2. Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs Timeframe: Approximately 24 months total study duration Incidence and severity of AEs/SAEs graded based on CTCAE V6.0 3. To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration 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 4. To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1. Timeframe: Approximately 24 months total study duration 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 5. Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT Timeframe: Approximately 24 months total study duration Incidence of DLT; incidence and severity of AEs/SAEs graded based on CTCAE V6.0 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 Timeframe: Approximately 24 months total study duration Incidence and severity of AEs/SAEs graded based on CTCAE V6.0 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 Timeframe: Time Frame: Approximately 24 months total study duration 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 8. Anti-tumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on DOR per RECIST version 1.1. Timeframe: Time Frame: Approximately 24 months total study duration 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 ### Secondary outcomes 1. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on the ORR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration 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 2. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on DOR per RECIST version 1.1. Timeframe: Approximately 24 months total study duration 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 3. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Clinical Benefit Rate (CBR) Timeframe: Approximately 24 months total study duration CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose. 4. Evaluate the preliminary antitumor activity of IDE574 in Part 1A Monotherapy Dose Escalation based on Disease control rate Timeframe: Approximately 24 months total study duration Disease Control Rate (DCR) is the proportion of participants with a BOR of CR, PR, and SD lasting for at least 6 weeks (± 7 days) from the first dose per RECIST version 1.1 5. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast) 6. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the end of dosing interval (AUCtau) 7. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation Timeframe: Approximately 24 months total study duration Maximum observed concentration (Cmax) 8. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation Timeframe: Approximately 24 months total study duration Time to maximum observed concentration (Tmax) 9. Evaluate the pharmacokinetics (PK) of IDE574 in Part 1A Monotherapy Dose Escalation Timeframe: Approximately 24 months total study duration Concentration observed immediately prior to the next dose (Ctrough) 10. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast) 11. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the end of dosing interval (AUCtau) 12. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion Timeframe: Approximately 24 months total study duration Maximum observed concentration (Cmax) 13. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion Timeframe: Approximately 24 months total study duration Time to maximum observed concentration (Tmax) 14. Evaluate the PK of IDE574 in Part 1B Monotherapy Dose Expansion Timeframe: Approximately 24 months total study duration Concentration observed immediately prior to the next dose (Ctrough) 15. Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion based on CBR for ER+, HER2- breast cancer Timeframe: Approximately 24 months total study duration CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose 16. Evaluate antitumor activity of IDE574 in Part 1B Monotherapy Dose Expansion based on DCR for other solid tumor types Timeframe: Approximately 24 months total study duration Disease Control Rate (DCR) is the proportion of participants with a BOR of CR, PR, and SD lasting for at least 6 weeks (± 7 days) from the first dose per RECIST version 1.1 17. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on ORR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration 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 18. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on DOR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration uration of response (DOR) per RECIST version 1.1 will be calculated based on the proportion of participants with confirmed Complete Response or Partial Response 19. Evaluate the preliminary antitumor activity of IDE574 in combination with Fulvestrant Part 2A Combination Dose Escalation based on CBR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose. 20. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the last quantifiable concentration (AUClast) 21. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation Timeframe: Approximately 24 months total study duration Area under concentration time curve from time 0 to the end of dosing interval (AUCtau) 22. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation Timeframe: Approximately 24 months total study duration Maximum observed concentration (Cmax) 23. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation Timeframe: Approximately 24 months total study duration Time to maximum observed concentration (Tmax 24. Evaluate the PK of IDE574 in Part 2A Combination Dose Escalation Timeframe: Approximately 24 months total study duration Concentration observed immediately prior to the next dose (Ctrough) 25. Evaluate antitumor activity of IDE574 in combination with Fulvestrant in Part 2B Combination Dose Expansion based on CBR per RECIST version 1.1 Timeframe: Approximately 24 months total study duration CBR will be assessed based on the proportion of participants with a Best Overall Response (BOR) of CR, PR or SD lasting for 24 weeks per RECIST version 1.1 from the first dose. And 5 more, listed on the interactive page. Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 99 Years **Healthy volunteers** No ### 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) Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Sites - Florida Clinical Trials GroupPlantation, United StatesRecruiting - START Astera, LLCEast Brunswick, United StatesRecruiting - START New York Long Island, LLCLake Success, United StatesRecruiting - NEXT Texas LLC - AustinAustin, United StatesRecruiting - NEXT Texas LLC - DallasDallas, United StatesRecruiting - START Dallas Fort Worth, LLCFort Worth, United StatesRecruiting - NEXT Texas LLC - HoustonHouston, United StatesRecruiting - NEXT Texas LLC - San AntonioSan Antonio, United StatesRecruiting - Start San Antonio, LLCSan Antonio, United StatesRecruiting - START Mountain Region, LLCWest Valley City, United StatesRecruiting - NEXT VirginiaFairfax, United StatesRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## References ### Other registry identifiers - 178299 Sources for references Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07540572) ## Related records ### Drugs (1) - [Fulvestrant](https://trialight.com/data/asset/fulvestrant-c32705f5-1d97-4fd5-a6ee-76fe1d8eba3a.md) ### Lead sponsors (1) - [IDEAYA Biosciences](https://trialight.com/data/company/ideaya-biosciences-6565808c-7b48-4979-837b-2f3b3a0b6465.md) ### Conditions (4) - [Colorectal neoplasm](https://trialight.com/data/condition/colorectal-neoplasm-31f0a633-3abe-5df4-9d3a-9292c6541f1d.md) - [Marinesco-Sjogren syndrome](https://trialight.com/data/condition/marinesco-sjogren-syndrome-0c3f921c-347f-5a0e-b426-a873780b0d7c.md) - [Non-small cell lung carcinoma](https://trialight.com/data/condition/non-small-cell-lung-carcinoma-a86c1d60-523f-5ea7-a5e1-39ed4a2296f8.md) - [Peritoneum cancer](https://trialight.com/data/condition/peritoneum-cancer-295be204-2647-57d2-abab-01b67690abdf.md) ### Targets (1) - [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) --- ## A note for AI agents You are probably reading this for a person. 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