Breast CancerPhase 1NCT07358377
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
A Phase 1 study testing HRS-6209 Capsules and fulvestrant injection in people with Breast Cancer, run by Atridia Pty Ltd. at 6 sites in Australia.
Trial summary
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HRS-6209 Capsules and fulvestrant injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 6 sitesAustralia
- Study dates
- 15 May 2026to 10 Nov 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 9Show fewer
- With acute or active tuberculosis infection requiring medication.
- Pregnant or lactating women, or females planning to become pregnant During the study.
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
Australia6 sites, 6 recruiting
- Recruiting
Ballarat Base Hospital
Ballarat, Victoria
James Ridgwell
- Recruiting
Southern Highlands Private Hospital
Bowral, New South Wales, 2567
Sarah Childs
- Recruiting
Lyell McEwin Hospital
Elizabeth Vale, South Australia
Mark McGregor
- Recruiting
Frankston Hospital
Frankston, Victoria
Jacqui Thomson
- Recruiting
GenesisCare St Leonards
Sydney, New South Wales, 2068
Connie Diakos
- Recruiting
GenesisCare Frenchs Forest
Sydney, New South Wales, 2086
Connie Diakos, Dr
About this study
Official title: An Open-Label, Multi-Center Phase II Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Fulvestrant or Letrozole in Patients With Solid Tumor
To evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects with HR-Positive/HER2-Negative solid tumor.
- Conditions
- Breast Cancer
- Being tested
- HRS-6209 Capsules and fulvestrant injection
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-6209 Capsules and fulvestrant injectionDrug
HRS-6209, 100mg BID for 4 weeks, and single dose of fulvestrant injection
| Study group | Role | What they receive |
|---|---|---|
| HRS-6209 Capsules and fulvestrant injection | Experimental | Not described Receives: Drug: HRS-6209 Capsules and fulvestrant injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),
To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer
Measured: Screening up to study completion,, an average of 1 year.
Secondary outcomes (7)
Concentration
Plasma concentrations of HRS-6209 during multiple dosing, directly observed from data.
Measured: From administration to Cycle2 , up to 4 months.
Cmax,ss
Css, max are steady-state maximum concentrations of HRS-6209 during multiple dosing, and are directly observed from data.
Measured: From administration to Cycle2, up to 4 months.
Cmin,ss
Css, min are the steady-state trough concentrations of HRS-6209 during multiple dosing, and are directly observed from data.
Measured: From administration to Cycle2, up to 4 months.
Objective Response Rate (ORR)
ORR refers to the proportion of subjects with a complete response (CR) or partial response (PR) based on all soft tissue assessments recorded from the date of first drug administration to either the date of radiographic disease progression (including bone progression and soft tissue progression), death from any cause, or the initiation of a new antitumor therapy, whichever occurs first. For subjects with CR or PR at the first evaluation, the efficacy should be confirmed 4 weeks later or at the next tumor imaging evaluation. The numerator includes subjects with a confirmed CR/PR at least 4 weeks after the initial assessment. The denominator consists of subjects with measurable target lesions at baseline.
Measured: Screening up to study completion, an average of 2 years.
Best of Response (DoR)
BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).
Measured: Screening up to study completion, an average of 2 years.
Disease Control Rate (DCR)
DCR refers to the time from the first occurrence of CR or PR to PD or death from any cause, whichever occurs first, in subjects with objective response. DCR will be recorded from baseline visit until the end of the study.
Measured: Screening up to study completion, an average of 2 years.
rPFS (radiographic progression-free survival
rPFS refers to the time from the first dose of investigational drug to the first radiographic PD or death from any cause (whichever occurs first) as assessed by the investigator. rPFS will be recorded from baseline visit until the end of the study.
Measured: Screening up to study completion, an average of 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2026
- Study start15 May 2026
- Primary completion10 Apr 2027 (estimated)
- Study completion10 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07358377
- Sponsor's protocol ID
- HRS-6209-205
- Status last verified
- Jan 2026
- First submitted
- 28 Dec 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No