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HRS-1358 + dalpiciclib
- Development stage
- Unknown
- Lead developer
- Shandong Suncadia Medicine
- Modality
- PROTACs (E3 ligase recruitment) → Targeted Protein Degraders (TPDs) → Small Molecules, Bivalent/Multivalent Binders → Multivalent & Scaffold-Based Small Molecules → Small Molecules
- Administration
- Oral
01
Overview
**HRS-1358 + dalpiciclib** is an investigational combination therapy for metastatic or locally advanced breast cancer, currently in early-phase clinical development. HRS-1358 is a small molecule *proteolysis-targeting chimera* (PROTAC) that degrades estrogen receptors (ERs), designed as an estrogen receptor degrader. Dalpiciclib (SHR6390) is an oral, selective, small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). The combination aims to enhance antitumor effects by simultaneously antagonizing estrogen receptor signaling (via ER degradation) and inhibiting cell cycle progression (via CDK4/6 inhibition), potentially overcoming endocrine therapy resistance in hormone receptor (HR) positive, HER2-negative breast cancer. Clinical trials are ongoing to establish the safety, dose-limiting toxicities, pharmacokinetics, and recommended dosing for this combination[2][3][4].
- Other names
- HRS-1358 + dalpiciclib isethionate
02
Targets
CDK6 (Cyclin-dependent kinase 6)CDK4 (Cyclin-dependent kinase 4)
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