RecruitingPhase 1

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

Australia15 participantsStarted 2026-05-15

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

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

Inclusion criteria

. 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

Exclusion criteria

. 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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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.

Trial details

NCT IDNCT07358377

SponsorAtridia Pty Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-04-10

Contact for this trial

Kathy You

+61 02 9299 0433 kathyyou@atridia.com

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