A Phase 1 Study of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
HRS8807、SHR6390: HRS8807 in combination with SHR6390
HRS8807、SHR6390: HRS8807 in combination with SHR6390
Study summary
The study is to assess safety and tolerability of HRS8807 monotherapy and in combination with SHR6390 in subjects with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Histological diagnosis of metastatic or locally advanced breast cancer; Histologically proven diagnosis of ER-positive, HER2-negative;
2. At least 1 line of endocrine therapy in the metastatic or advanced setting that had progressed or intolerance; ≤ 2 lines of chemotherapy for metastatic or advanced disease;
3. Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1;
4. Expected survival of more than 3 months.
Exclusion Criteria:
1. All patients in monotherapy and or in combination wih phase who are known allergic to HRS8807 or SHR6390 ingredient;
2. Presence of symptomatic metastatic visceral disease ;
3. Patients with known active brain metastases;
4. Clinically serious cardiovascular disease;
5. Abnormal electrocardiographic (ECG) with clinical significancy by investigator judgement;
6. Abnormal thyroid function laboratory results;
7. Active infection or unexplained fever \>38.5℃ during screening period or on the day of the first dose.
Primary outcome measure(s)
MTD — Change From Baseline at 28 days Maximum Tolerated Dose (MTD) of HRS8807 monotherapy and in combination with SHR6390
RP2D — Change From Baseline at 28 days select the Recommended Phase 2 Dose (RP2D) of HRS8807 monotherapy and in combination with SHR6390
Adverse events (AE) and serious AE (SAE) — Up to 30 days after end of treatment AEs and SAEs as characterized by frequency and severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE version 5.0\]).
Trial sites (1)
Facility
City
Region
Status
Fudan University Shanghai Cancer Center
Shanghai
Shanghai Municipality
More Shanghai Hengrui Pharmaceutical Co., Ltd. trials in China
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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