To Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of HRS-6209 in Subjects With HR-Positive/HER2-Negative Solid Tumor

Atridia

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Breast Cancer

Treatments: Drug: HRS-6209 Capsules and fulvestrant injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT07358377

HRS-6209-205

Details and patient eligibility

About

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

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

HRS-6209 Capsules and fulvestrant injection

Experimental group

Treatment:

Drug: HRS-6209 Capsules and fulvestrant injection