Clinical trial NCT06974929: A Clinical Study of HRS-6209 in Combination With Letrozole in Patients With Breast Cancer
Official title: An Open-Label, Multicenter Phase Ib/II Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of HRS-6209 in Combination With Letrozole in Patients With Breast Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Breast Cancer
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-05-16
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a study to evaluate the safety, tolerability, and pharmacokinetic characteristics of HRS-6209 combined with letrozole in breast cancer patients, and preliminarily observe its anti-tumor efficacy.


Eligibility criteria: Inclusion Criteria:

1. Women aged 18-75 years.
2. ECOG performance status 0-1.
3. Menopausal status.
4. Evidence of radiographic disease progression during or after the last systemic anti-tumor therapy prior to the first study drug administration.
5. At baseline, there must be at least one measurable, extracranial lesion that meets RECIST v1.1 criteria.
6. Expected survival \> 3 months.
7. Women of childbearing potential must agree to use highly effective contraceptive measures during the study treatment and for 6 months after the end of treatment. Women of childbearing potential must have a negative serum HCG test within 7 days prior to study enrollment and must not be breastfeeding.
8. Voluntarily agree to participate in this clinical trial, willing and able to comply with the study visits and procedures, understand the study procedures, and have signed the informed consent form.

Exclusion Criteria:

1. Symptomatic visceral metastasis and other conditions, and the researcher judged that endocrine therapy was not suitable for use.
2. History of clinically serious cardiovascular disease.
3. The ECG examination was abnormal.
4. Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
5. The subjects were in acute infection or active tuberculosis and needed drug treatment.
6. The patients received surgery, chemotherapy, immunotherapy and macromolecular targeted therapy within 4 weeks before the first medication.
7. Pregnant and lactating women, or intending to become pregnant during the study.
8. There was a clear history of neurological or mental disorders and the subjects had a history of psychotropic drug abuse or drug abuse.
9. In the course of this study, it is expected to receive other anti-tumor treatments or drugs.

Primary outcomes:
measure: Dose-limiting toxicity (DLT)
timeFrame: 28 days after the first dose.
measure: Maximum tolerated dose (MTD)
timeFrame: 28 days after the first dose.
measure: Recommended phase II dose (RP2D)
timeFrame: 28 days after the first dose.
measure: Adverse events (AEs)
timeFrame: About 1 year.
measure: Serious adverse events (SAEs)
timeFrame: About 1 year.
measure: Objective response rate (ORR)
timeFrame: About 1 year.
Secondary outcomes:
measure: Best overall response (BOR)
timeFrame: About 1 year.
measure: Duration of response (DoR)
timeFrame: About 1 year.
measure: Clinical benefit rate (CBR)
timeFrame: About 1 year.
measure: Progression-free survival (PFS)
timeFrame: About 1 year.
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute and Hospital
state: Tianjin
Study officials:
References: