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 now · Phase 1

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT07358377

Run by

Atridia Pty Ltd.

People needed

15

Starts

2026-05-15

Expected to finish

2027-11-10

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Plan to receive any other anti-tumor therapy during the study.
• Active brain metastases .
• Have poorly controlled or severe cardiovascular disease, including (1) congestive heart failure.
• Previous use of fulvestrant
• clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
• With uncontrollable chronic systemic complications (such as severe chronic lung, liver, kidney, or heart disease).
• With acute or active tuberculosis infection requiring medication.
• Pregnant or lactating women, or females planning to become pregnant During the study.
• 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

Where it is running

• Lyell McEwin Hospital — Elizabeth Vale, South Australia, Australia (enrolling)
• Ballarat Base Hospital — Ballarat, Victoria, Australia (enrolling)
• Frankston Hospital — Frankston, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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