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FIH Study of RGT-419B Alone and With Endocrine Therapy in HR-Positive, HER2-Negative Advanced/Metastatic Breast Cancer

First trial of RGT-419B for specific advanced breast cancer types.

Recruiting
18 years and older
All
Phase 1

This study is for adults with **advanced breast cancer** that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), which means the cancer grows with hormones but not with a protein called HER2. It's a **First-in-Human (FIH)** study, testing a new drug, RGT-419B, taken by mouth alone or with **endocrine therapy**, which is hormone treatment. The study aims to see if this drug is safe, how it behaves in the body (**pharmacokinetics**), and if it works to stop cancer growth after other treatments have stopped working.

  • Participants must be 18 or older and have previously received certain cancer treatments.
  • The study involves taking a new medicine and attending regular check-ups.
  • Participants must not have severe organ problems or be pregnant.
Study details
    Breast Cancer

NCT05304962

Regor Pharmaceuticals Inc.

26 April 2025

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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