Recruiting
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
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
ClinicalTrials.gov IDNCT07358377
PhasePHASE1
Enrollment15
SponsorAtridia Pty Ltd.
Age18 Years
SexALL
Conditions studied
Breast Cancer
About this study
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
Interventions
- Drug: HRS-6209 Capsules and fulvestrant injection — HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection
Primary outcomes
- Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs), (Screening up to study completion,, an average of 1 year.)
Eligibility information
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
Study locations
- Southern Highlands Private Hospital, Bowral, New South Wales 2567 Australia
- GenesisCare St Leonards, Sydney, New South Wales 2068 Australia
- GenesisCare Frenchs Forest, Sydney, New South Wales 2086 Australia
- Lyell McEwin Hospital, Elizabeth Vale, South Australia Australia
- Ballarat Base Hospital, Ballarat, Victoria Australia
- Frankston Hospital, Frankston, Victoria Australia
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.