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
Subjects have received live or attenuated live vaccines within 4 weeks before the first use of the investigational drug.
Subjects have undergone major organ surgery within 4 weeks before the first use of the investigational drug.
Subjects require long-term or high-dose use of non-steroidal drugs.
Subjects have not recovered from adverse events (AEs) caused by previous anti-tumor treatment to ≤ grade 1.
Single group
QLS1304 tablet+Fulvestrant or QLC1401
DrugQLS1304 combined with endocrine therapy
QLS1304 tablet+Fulvestrant，AI or QLC1401+CDK4/6i
DrugQLS1304 combined with endocrine therapy
Recommended Phase II Dose (RP2D) of QLS1304 in combo therapy
objective response rate（ORR）
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