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