Not Yet RecruitingPhase 1

To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negative Solid Tumor

15 participantsStarted 2026-03-15

Plain-language summary

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

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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.

Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),

Timeframe: Screening up to study completion,, an average of 1 year.

NCT IDNCT07358377

SponsorAtridia Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-10

Kathy You