NCT04993430

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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).

Conditions

• ER-Positive, HER2-Negative Breast Cancer

Interventions

Type	Name	Description
DRUG	HRS8807	HRS8807 monotherapy
DRUG	HRS8807	HRS8807 monotherapy
DEVICE	HRS8807、SHR6390	HRS8807 in combination with SHR6390
DRUG	HRS8807、SHR6390	HRS8807 in combination with SHR6390

Timeline

• Start date: 2021-10-26
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2021-08-06
• Last updated: 2021-11-16

Locations

1 site across 1 country: China