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NCT Number: 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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Southern Highlands Private Hospital, Bowral, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

HRS-6209 Capsules and fulvestrant injection

Drug

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

Primary outcomes

  1. Safety by reporting incidence and severity of Adverse events (graded as per CTCAE V5.0) of adverse events (AEs) and serious adverse events (SAEs),

    Time frame: Screening up to study completion,, an average of 1 year.

    To safety and tolerability of HRS-6209 in combination with fulvestrant in patients with advanced unresectable or metastatic breast cancer

Secondary outcomes

  1. Concentration

    Time frame: From administration to Cycle2 , up to 4 months.

    Plasma concentrations of HRS-6209 during multiple dosing, directly observed from data.

  2. Cmax,ss

    Time frame: From administration to Cycle2, up to 4 months.

    Css, max are steady-state maximum concentrations of HRS-6209 during multiple dosing, and are directly observed from data.

  3. Cmin,ss

    Time frame: From administration to Cycle2, up to 4 months.

    Css, min are the steady-state trough concentrations of HRS-6209 during multiple dosing, and are directly observed from data.

  4. Objective Response Rate (ORR)

    Time frame: Screening up to study completion, an average of 2 years.

    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.

  5. Best of Response (DoR)

    Time frame: Screening up to study completion, an average of 2 years.

    BOR refers to the best response of tumor evaluation, including CR, PR, stable disease (SD), progressive disease (PD), and not evaluable for response (NE).

  6. Disease Control Rate (DCR)

    Time frame: Screening up to study completion, an average of 2 years.

    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.

  7. rPFS (radiographic progression-free survival

    Time frame: Screening up to study completion, an average of 2 years.

    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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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