RecruitingPhase 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

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

Sponsor

Atridia Pty Ltd.

Enrollment

15 participants

Start Date

May 15, 2026

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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

Eligibility

Min Age: 18 Years

Inclusion Criteria4

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 Criteria9

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