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

NCT07540572
clinicaltrials.gov
Phase
Phase 1
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Recruitment status
Recruiting
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Participants
160
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Lead sponsor
IDEAYA Biosciences
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Start date
2026-03-17
clinicaltrials.gov
Number of sites
11
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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.
clinicaltrials.gov
Short title
A Study to Investigate the Safety, Pharmacokinetics, and Preliminary Efficacy of IDE574 Therapy in Adult Participants With Advanced Solid Tumors
clinicaltrials.gov
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
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 1
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Study type
Interventional
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Completion date
2030-06-30
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First posted
2026-04-20
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Registry last updated
2026-06-16
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Primary completion date
2030-03-30
clinicaltrials.gov
Start date
2026-03-17
clinicaltrials.gov

Participants
160
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Participant count basis
Estimated
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Planned participants
160
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Protocol amendments
1
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Number of sites
11
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
IDEAYA Biosciences
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07540572
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ClinicalTrials.gov ID
NCT07540572
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Registry record
Open registry record
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Allocation
Not randomised
Model
Parallel groups
Purpose
Treatment
Masking
No masking
Sources for study design
clinicaltrials.gov

  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

  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
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

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
clinicaltrials.gov

  • 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
clinicaltrials.gov

Other registry identifiers

  • 178299
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (4)

Targets (1)