A Phase III Study of ESG401 for Locally Advanced or Metastatic HR+/HER2- Breast Cancer

Exclusion Criteria

• •Received chemotherapy, targeted therapy, immunotherapy, interventional therapy or other systemic anti-cancer therapie within 4 weeks before the first investigational product administration;
• •Toxicities from prior anti-tumor therapy not recovering to ≤ Grade 1;
• •Received major surgeries 4 weeks prior to the first dose of study treatment or planned to receive major surgeries during the study ;
• •Prior topoisomerase I inhibitor therapy, including antibody-drugconjugate(ADC) therapy, or prior TROP2 targeted therapy, or use of any investigational anti-cancer drug within 28 days or 5 half-lives before the first investigational product administration;
• •New thromboembolic events, intestinal obstruction, gastrointestinal bleeding or perforation within 6 months;
• •Uncontrolled systemic bacterial, viral or fungal infections;
• •Subjects with symptomatic or untreated CNS metastases, or those requiring ongoing treatment for CNS metastases;
• •Patients with Primary CNS malignancy；or patients with other malignancies within 3 years prior to the first dose;
• •Patients with uncontrollable systemic diseases;
• •Patients with gastrointestinal diseases (such as chronic gastritis, chronic enteritis or gastric ulcers), or with a previous history of severe or chronic diarrhea;
• •Subjects with clinically significant cardiovascular disease;
• •Human Immunodeficiency Virus (HIV) infection;
• •Active hepatitis B or hepatitis C;
• •Known immediate or delayed hypersensitivity reaction to irinotecan or other camptocampin derivatives such as topotecan or to have had grade ≥3 gastrointestinal reactions associated with irinotecan, or allergies, or to any investigational drug or excipient ingredient;
• •Pregnant or lactating women.