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Clinical Trials in Australia / NCT07358377
Recruiting Phase 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

NCT07358377 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1
Started
2026-05-15
Last updated
2026-08-11

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

HRS-6209 Capsules and fulvestrant injection

HRS-6209 Capsules and fulvestrant injection: HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Southern Highlands Private Hospital Bowral New South Wales Recruiting
GenesisCare St Leonards Sydney New South Wales Recruiting
GenesisCare Frenchs Forest Sydney New South Wales Recruiting
Lyell McEwin Hospital Elizabeth Vale South Australia Recruiting
Ballarat Base Hospital Ballarat Victoria Recruiting
Frankston Hospital Frankston Victoria Recruiting

More Atridia Pty Ltd. trials in Australia

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07358377 on ClinicalTrials.gov ↗ ← All trials in Australia