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A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer

A Trial of HRS-6209-205 to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Combination Therapy in Subjects With HR-Positive/HER2-Negative Cancer

Recruiting
18 years and older
All
Phase 1

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Overview

To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.

Eligibility

Inclusion Criteria

  1. Ability to understand the trial procedures and possible adverse events, voluntarily participate in the trial.
  2. Adequate bone marrow and other vital organ functions
  3. Adequate liver function tests
  4. HR-positive or HER2-negative solid tumor patients

Exclusion Criteria

  1. Plan to receive any other anti-tumor therapy during the study.
  2. Active brain metastases .
  3. Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
  4. Previous use of fulvestrant
  5. clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
  6. With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
  7. With acute or active tuberculosis infection requiring medication.
  8. Pregnant or lactating women, or females planning to become pregnant During the study.
  9. Known history of clinically significant liver disease, untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen \[HBsAg\] or hepatitis B core antibody \[HBcAb\] positive

Study details
    Breast Cancer

NCT07358377

Atridia Pty Ltd.

27 June 2026

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FAQs

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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