Phase 1 Lung Cancer Trial, Recruiting NCT07540572 Sponsor: IDEAYA Biosciences Condition: Lung Cancer
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Phase 1 Lung Cancer Trial, Recruiting

NCT07540572
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have a stored tissue sample available for testing
  • You have advanced or spreading breast cancer that is ER-positive and HER2-negative, a type of non-small cell lung cancer, a type of prostate cancer, or a specific type of colorectal cancer, and your cancer has continued to grow after at least one standard treatment (this applies to one part of the trial only)
  • You have ER-positive, HER2-negative breast cancer that has continued to grow after at least one hormonal therapy and a specific type of targeted therapy called a CDK4/6 inhibitor (this applies to other parts of the trial)
  • If you are a woman with ER-positive, HER2-negative breast cancer who could still become pregnant (or have only had your tubes tied), you must be willing to have your menstrual cycle medically stopped for certain parts of the trial
  • If you are a woman who can no longer become pregnant, you must be aged 60 or over, or under 60 with no period for at least 12 months, or have had both ovaries removed
  • You are generally well enough to carry out light daily activities (confirm with trial site)
  • Your bone marrow, kidneys, and liver are functioning well enough, as shown by blood tests
  • Your life expectancy is more than 3 months
  • You are able to swallow and keep down tablets or capsules by mouth
  • You are able to follow the contraception or barrier method requirements of the trial

Who may not be able to join:

  • You have brain tumours that are causing symptoms, or cancer that has spread to the lining around the brain or spinal cord
  • You have a primary brain cancer, or have had another type of cancer within the last 2 years (with some exceptions for certain fully treated localised cancers)
  • You have a digestive system condition that could affect how your body absorbs the study medication
  • You have an active liver or bile duct disease
  • You have an active infection (bacterial, fungal, or viral) that is not under control
  • You have had a significant heart problem or blood clotting event within the 6 months before joining the trial
  • You still have significant side effects from a previous experimental cancer treatment that have not improved sufficiently
  • More than 25% of your bone marrow has previously been treated with radiation therapy
  • You have a known allergy or sensitivity to the study drug or its ingredients, or to a drug called fulvestrant and its ingredients (for certain parts of the trial only)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 30 June 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
IDEAYA Biosciences
Registry
ClinicalTrials.gov
Start date
17 March 2026
Est. completion
30 March 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Safety and Tolerability of IDE574 in Part 1 A Monotherapy Dose escalation; Safety and Tolerability of IDE574 in Part 1B Monotherapy Dose expansion based on incidence and severity of AEs/SAEs; To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on the ORR per RECIST version 1.1; To evaluate anti-tumor activity of IDE574 of IDE574 in Part 1B Monotherapy Dose expansion based on DOR per RECIST version 1.1.; Safety and tolerability of IDE574 in combination with Fulvestrant in Part 2A Combination Dose Escalation based on incidence of DLT; Safety and tolera...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov