A Phase Ib/II Clinical Study to Evaluate Safety, Preliminary Efficacy and PK Characteristic of QLS1304 Combined With Endocrine Therapy in ER+/HER2- Breast Cancer Patients
This study is a multi-center, open label, phase Ib/II clinical trial aimed at evaluating the safety, preliminary efficacy characteristic and PK characteristics of QLS1304 in combined with endocrine therapy in ER+/HER2- breast cancer patients. This study was divided into two stages: combo dose escalation and dose expansion.
• Volunteer to participate in this study, sign an informed consent form and have good compliance;
• Age ≥ 18 years old, Male or female
• ECOG score: 0-1
• Expected survival ≥ 12 weeks
• Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology;
• Failed to at least one therapy line of endocrine therapy ;
• Baseline presence of at least one measurable lesion according to the RECIST v1.1;
• The functional level of important organs is basically normal, meeting the requirements of the scheme;
• Female subjects with fertility and male subjects must agree to use highly effective contraception during the study treatment period and within 180 days after the last medication;
⁃ Female subjects with fertility must have a negative serum HCG test within 7 days before the first medication in the study, and must be in non lactation.
⁃ Volunteer to participate in this clinical trial, willing and able to follow the procedures related to clinical visits and research, understand the research procedures, and have signed informed consent.