160 Participants NeededMy employer runs this trial

IDE574 + Fulvestrant for Breast Cancer

Recruiting at 11 trial locations
IC
Overseen ByIDEAYA Clinical Trials
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: IDEAYA Biosciences
Must be taking: Endocrine therapy
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?

This trial tests a new treatment called IDE574 for certain advanced or metastatic cancers. The study aims to determine if IDE574 is safe and effective, both alone and with fulvestrant, specifically for ER+ HER2- breast cancer. It seeks participants who have tried other treatments without success, particularly those whose breast cancer progressed after hormone therapy and CDK4/6 inhibitors. This trial may suit individuals managing advanced breast cancer and considering new treatment options. As a Phase 1, Phase 2 trial, it focuses on understanding how the treatment works in people and measuring its effectiveness in an initial group.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that IDE574 has been effective in fighting tumors in earlier studies. It targets enzymes involved in cancer growth and successfully lowers tumor markers in various cancer models. However, detailed safety information is not yet available, so its safety for humans remains uncertain.

Researchers are further testing IDE574 in combination with fulvestrant. Fulvestrant is a well-known breast cancer treatment and is generally well-tolerated, though some individuals may experience fatigue or nausea.

This trial is in its early stages and primarily aims to assess the safety of IDE574, both alone and with fulvestrant. Early trials focus on identifying side effects and understanding how patients tolerate the treatment. Researchers will closely monitor participants to ensure their safety.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about IDE574 for breast cancer because it offers a new approach to treatment. Unlike current treatments that often target estrogen receptors or HER2 proteins, IDE574 works by a different mechanism, potentially providing a new option for patients with ER+ HER2- advanced or metastatic breast cancer. This treatment is being tested both alone and in combination with fulvestrant, which is known for blocking estrogen receptors. The combination might enhance effectiveness, offering hope for improved outcomes compared to existing therapies like hormone blockers or chemotherapy.

What evidence suggests that this trial's treatments could be effective for breast cancer?

Research has shown that IDE574, a new drug, has delivered promising results in early tests against certain solid tumors, including breast cancer. It blocks specific enzymes, KAT6 and KAT7, which helps stop tumor growth. In this trial, some participants will receive IDE574 alone, while others will receive it in combination with fulvestrant, a current treatment. Combining IDE574 with fulvestrant may lead to better outcomes. Previous studies with similar drug combinations have demonstrated that patients can live longer without their disease worsening. Although clinical data collection is ongoing, IDE574 could become a promising new option for treating advanced breast cancer.46789

Are You a Good Fit for This Trial?

This trial is for adults with advanced or metastatic solid tumors (like certain breast, lung, prostate, or colorectal cancers) who have already tried standard treatments. Participants need to be in generally good health, able to take oral medication, and willing to use contraception if needed.

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

Trial Overview

The study is testing a new drug called IDE574 alone in people with various advanced cancers and together with fulvestrant in those with a specific type of breast cancer (ER+, HER2-). The main goals are to check safety and how the body processes these drugs.

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+

Citations

News Releases

The company is planning to evaluate safety, efficacy and pharmacokinetics of IDE574 as a monotherapy in the Phase 1 dose escalation trial in ...

IDEAYA Biosciences Advances IDE574 Into Phase 1 As ...

Potential first in class dual inhibitor demonstrates strong preclinical efficacy and selectivity, targeting resistant solid tumours and ...

advanced or metastatic breast cancer: a phase 1 trial - PMC

Here, the authors report a phase I trial investigating the ER degrader, AC699, in patients with locally advanced or metastatic ER+/HER2- breast cancer.

News Releases

Dual KAT6/7 inhibition by IDE574 disrupts tumor lineage identity and delivers robust anti-tumor activity in patient-derived lung and breast ...

metastatic breast cancer after treatment with endocrine ...

Systematic review and meta-analysis of post-progression outcomes in ER+/HER2- metastatic breast cancer after treatment with endocrine therapy and CDK 4/6 ...

IDE574 / Ideaya Biosci

The KAT6/7 inhibitor IDE574 disrupts tumor lineage identity and drug tolerance to deliver robust antitumor activity in biomarker selected indications (AACR ...

IDE574 - Drug Targets, Indications, Patents

... Advanced or Metastatic ER+, HER2- Breast Cancer. 100 Clinical Results associated with IDE574. Login to view more data. 100 Translational Medicine associated ...

NCT07540572 | A Study to Investigate the Safety, ...

The purpose of this study is to evaluate the safety, preliminary efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of IDE574 as monotherapy in ...

Abstract 4483: The KAT6/7 inhibitor IDE574 disrupts tumor ...

IDE574 demonstrated robust suppression of both H3K23ac and H3K14ac in multiple cancer models. This was concomitant with selective chromatin ...