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160 Participants NeededMy employer runs this trial

IDE574 + Fulvestrant for Breast Cancer

Recruiting at 5 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 1 & 2
Sponsor: IDEAYA Biosciences
Must be taking: Endocrine therapy
Disqualifiers: Brain metastases, CNS malignancy, GI disease, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Inclusion Criteria

My life expectancy is more than 3 months.
My bone marrow, kidneys, and liver are working well.
I can safely swallow and keep down oral medication.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monotherapy Dose Escalation

Participants with advanced or metastatic solid tumors receive escalating doses of IDE574 to assess safety, tolerability, and determine dose-limiting toxicities

Approximately 24 months total study duration

Monotherapy Dose Expansion

Participants with ER+ HER2- advanced or metastatic breast cancer receive IDE574 at the determined safe dose level

Approximately 24 months total study duration

Combination Dose Escalation

Participants with ER+ HER2- advanced or metastatic breast cancer receive escalating doses of IDE574 in combination with fulvestrant to assess safety and tolerability

Approximately 24 months total study duration

Combination Dose Expansion

Participants with ER+ HER2- advanced or metastatic breast cancer receive IDE574 in combination with fulvestrant at the determined safe dose level

Approximately 24 months total study duration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fulvestrant
  • IDE574

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Group I: Monotherapy Dose Expansion (Part 1B)Experimental Treatment1 Intervention
Group II: Monotherapy Dose Escalation (Part 1A)Experimental Treatment1 Intervention
Group III: Combination Dose Expansion (Part 2B)Experimental Treatment2 Interventions
Group IV: Combination Dose Escalation (Part 2A) IDE574 + FulvestrantExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

IDEAYA Biosciences

Lead Sponsor

Trials
6
Recruited
1,300+

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