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Trial Title:
A Trial of HRS-6209 in Combination With Fulvestrant, Letrozole, HRS-8080, or HRS-1358 in Breast Cancer Patients
NCT ID:
NCT06555068
Condition:
Advanced Unresectable or Metastatic Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Letrozole
Fulvestrant
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
HRS-6209 in Combination with Fulvestrant
Description:
HRS-6209 in Combination with Fulvestrant
Arm group label:
Treatment group A: HRS-6209 in Combination with Fulvestrant
Intervention type:
Drug
Intervention name:
HRS-6209 in Combination with HRS-1358
Description:
HRS-6209 in Combination with HRS-1358
Arm group label:
Treatment group E: HRS-6209 in Combination with HRS-1358
Intervention type:
Drug
Intervention name:
HRS-6209 in Combination with Letrozole
Description:
HRS-6209 in Combination with Letrozole
Arm group label:
Treatment group B：HRS-6209 in Combination with Letrozole
Intervention type:
Drug
Intervention name:
HRS-6209 in Combination with HRS-8080
Description:
HRS-6209 in Combination with HRS-8080
Arm group label:
Treatment group C：HRS-6209 in Combination with HRS-8080
Intervention type:
Drug
Intervention name:
HRS-6209 in Combination with HRS-1358
Description:
HRS-6209 in Combination with HRS-1358
Arm group label:
Treatment group D：HRS-6209 in Combination with HRS-1358
Summary:
The study is being conducted to evaluate the safety, PK and efficacy of HRS-6209 in
Combination with Fulvestrant, Letrozole, HRS-8080, or HRS-1358 for advanced unresectable
or metastatic breast cancer
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Females aged 18-75 years (inclusive);
2. ECOG performance status (PS) score of 0-1;
3. Patients with histopathologically confirmed metastatic or unresectable locally
advanced breast cancer, histopathologically confirmed ER-positive or PR-positive;
4. Menopausal status:
1. Having had bilateral oophorectomy, or aged ≥ 60 years old; or
2. Aged < 60, natural menopause with E2 and FSH at postmenopausal levels; or
3. Premenopausal or perimenopausal patients, but they should receive LHRH agonists
during the study and the treatment should be initiated prior to study
treatment.
5. Disease progression evidenced by imaging during or after the last systemic
anti-tumor treatment prior to the first dose (limited to the efficacy expansion
stage);
6. With at least one extracranial measurable target lesion at baseline per RECIST v1.1;
7. Life expectancy of > 3 months;
8. The functional level of organs must meet the following requirements :
Absolute neutrophil count ≥ 1.5 × 109/L; Platelet count ≥ 90 × 109/L; Hemoglobin ≥
10 g/dL; Normal blood creatinine or creatinine clearance ≥ 50 mL/min (calculated by
standard Cockcroft-Gault formula); Serum albumin ≥ 3.0 g/dL; Total bilirubin ≤ 1.5 ×
upper limit of normal (ULN); Alanine aminotransferase (ALT) and aspartate
aminotransferase (AST) ≤ 2.5 × ULN, or ≤ 5.0 × ULN for patients with liver
metastasis; Prothrombin time (PT) and partial thromboplastin time (APTT) ≤ 1.5 ×
ULN; Urine protein < 2+ or 24-h urine protein < 1 g; Left ventricular ejection
fraction (LVEF) ≥ 50%; QTcF ≤ 470 msec.
9. Female subjects of childbearing potential should agree to adopt effective
contraceptive measures during the study period and within 6 months after the end of
the study treatment; female subjects of childbearing potential must have a negative
serum HCG test result within 7 days before enrollment in the study and must not be
in the lactation;
10. Voluntarily participate in this clinical study, be willing and able to comply with
procedures related to clinical visits and study, and understand and have signed
written informed consent.
Exclusion Criteria:
1. With symptomatic visceral metastases deemed unfit for endocrine therapy by the
investigator;
2. With active brain metastases, carcinomatous meningitis, spinal cord compression, or
a history of primary tumors of the central nervous system;
3. History of clinically significant cardiovascular disease;
4. Abnormal ECG findings, which are judged by the investigator to be clinically
significant;
5. With factors that affect oral medication, active gastrointestinal diseases, or other
diseases that may obviously affect drug absorption, distribution, metabolism, or
excretion;
6. With clinically significant endometrial abnormalities, including but not limited to
endometrial hyperplasia and dysfunctional uterine bleeding;
7. Active infection or unexplained fever > 38.5 °C during the screening period or on
the day of first dose;
8. With uncontrollable chronic systemic complications as judged by the investigator.
9. With active autoimmune diseases, history of immunodeficiency and history of
autoimmune diseases, history of diseases or syndromes that require systemic
corticosteroids or immunosuppressive drugs, other acquired (HIV infection) or
congenital immunodeficiency, or history of organ transplantation (including
allogeneic bone marrow transplantation);
10. With acute infection or active tuberculosis requiring medication.
11. With a known history of clinically significant liver disease, untreated active
hepatitis;
12. Had other concurrent malignant tumors in the past 5 years;
13. Use of moderate and strong CYP3A4 inhibitors within 1 week or moderate and strong
CYP3A4 inducers within 2 weeks prior to the first dose;
14. Use of any drugs with the risk of prolonging QT/QTc interval or causing torsade de
pointes (TdP) within 4 weeks prior to the first dose, and with previous congenital
QT interval prolongation syndrome or a family history of QT interval prolongation;
15. Pregnant or lactating women, or females planning to become pregnant during the study
period;
16. With clear history of neural or mental disorders or with history of psychotropic
abuse or drug abuse;
19) Subjects who are expected to receive other anti-tumor therapies or drugs during this
study.
Gender:
Female
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Zip:
200032
Country:
China
Status:
Recruiting
Investigator:
Last name:
Jiong Wu
Email:
Principal Investigator
Start date:
August 12, 2024
Completion date:
August 2026
Lead sponsor:
Agency:
Jiangsu HengRui Medicine Co., Ltd.
Agency class:
Industry
Source:
Jiangsu HengRui Medicine Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06555068
