Actively Recruiting
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-01-12
300
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Phase Ib/II Clinical Study of QLS1304 Combined With Endocrine Therapy in the Treatment of ER+/HER2- Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Volunteer to participate in this study, sign an informed consent form and have good compliance
- Age 18 years or older, male or female
- ECOG performance status score of 0 or 1
- Expected survival of at least 12 weeks
- Local recurrent or metastatic advanced ER+/HER2- breast cancer confirmed by histopathology or cytopathology
- Have failed at least one line of endocrine therapy
- Presence of at least one measurable lesion at baseline according to RECIST v1.1
- Normal functional level of important organs meeting study requirements
- Female participants with fertility and male participants must agree to use highly effective contraception during treatment and for 180 days after last medication
- Female participants with fertility must have a negative serum HCG test within 7 days before first medication and must not be breastfeeding
- Willing and able to follow clinical visits and research procedures, and have signed informed consent
You will not qualify if you...
- Received live or attenuated live vaccines within 4 weeks before first use of investigational drug
- Underwent major organ surgery within 4 weeks before first use of investigational drug
- Require long-term or high-dose use of non-steroidal drugs
- Have not recovered from adverse events caused by previous anti-tumor treatment to grade 1 or less
- Known or suspected severe allergy to the investigational drug or its components
- Have other active malignant tumors within 5 years before first use of investigational drug
- Have brain metastases, carcinomatous meningitis, or leptomeningeal disease
- Have active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or severe lung function impairment
- Unable to swallow tablets or have gastrointestinal abnormalities affecting drug absorption
- History of severe cardiovascular or cerebrovascular disease within 6 months before first use of investigational drug
- History of hypertension not well controlled despite multiple antihypertension drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Cancer Hospital
Shanghai, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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