A Single-arm, Open-label, Multi-center Phase I Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of HRS-1358 Monotherapy or Combination With Dalpiciclib Isethionate Tablets in Patients With Metastatic or Locally Advanced Breast Cancer.
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).
• Histologically diagnosis of local advanced or metastatic breast cancer
• Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression
• At least 1 line of endocrine therapy in the metastatic or advanced setting
• ECOG performance status score: 0-1;
• Adequate organ functions as defined
• Ability to understand and voluntarily agrees to participate by giving written informed consent for the study.