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

Phase 1 Active not recruiting 46 enrolled Shanghai Hengrui Pharmaceutical Co., Ltd.

Non-randomizedSingle-groupOpen-labelTreatment

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).

Timeline

Start: 2021-10-26
Primary completion: 2026-12-30
Completion: 2026-12-30

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Dalpiciclib	Small molecule	—	—
Subject	HRS8807	Unknown	—	—

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

Summary

Timeline

Drugs

Indications