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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
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
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).
Official title: A Phase 1, Single Arm, Open-Label, Multicenter Study to Evaluate the Safety, Tolerability and Pharmacokinetic of HRS8807 Monotherapy and in Combination With SHR6390 in Subjects With ER-Positive, HER2-Negative Metastatic or Locally Advanced Breast Cancer
Key Details
Gender
FEMALE
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
46
Start Date
2021-10-26
Completion Date
2026-12-30
Last Updated
2026-05-28
Healthy Volunteers
No
Conditions
Interventions
HRS8807
HRS8807 monotherapy
HRS8807
HRS8807 monotherapy
HRS8807、SHR6390
HRS8807 in combination with SHR6390
HRS8807、SHR6390
HRS8807 in combination with SHR6390
Locations (1)
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China