NCT07358377 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
| NCT ID | NCT07358377 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Atridia Pty Ltd. |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 15 participants |
| Start Date | 2026-05-15 |
| Primary Completion | 2027-04-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 15 participants in total. It began in 2026-05-15 with a primary completion date of 2027-04-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07358377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07358377 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07358377 currently recruiting?
Yes, NCT07358377 is actively recruiting participants. Contact the research team at kathyyou@atridia.com for enrollment information.
Where is the NCT07358377 trial being conducted?
This trial is being conducted at Elizabeth Vale, Australia, Ballarat, Australia, Frankston, Australia.
Who is sponsoring the NCT07358377 clinical trial?
NCT07358377 is sponsored by Atridia Pty Ltd.. The trial plans to enroll 15 participants.
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