drugset / Trial / NCT05628870

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

NCT05628870

Phase 1 Recruiting 102 enrolled Shandong Suncadia Medicine Co., Ltd.
NaSingle-groupOpen-labelTreatment

Summary

The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients 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
2023-02-07
Primary completion
2025-06
Completion
2025-06-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Dalpiciclib Small molecule Oral
Subject HRS-1358 Unknown Oral

Indications