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ACTIVE NOT RECRUITING
NCT04993430
PHASE1

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

HRS8807

HRS8807 monotherapy

DRUG

HRS8807

HRS8807 monotherapy

DEVICE

HRS8807、SHR6390

HRS8807 in combination with SHR6390

DRUG

HRS8807、SHR6390

HRS8807 in combination with SHR6390

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China