Actively Recruiting
Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-01-13
180
Participants Needed
1
Research Sites
142 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a multi-center, open label, dose escalation/dose expansion phase I clinical trial aimed at evaluating the safety, tolerability, PK characteristics, and preliminary efficacy characteristics of QLS1304 monotherapy in patients with advanced malignant solid tumors. This study was divided into two stages: dose escalation and dose expansion.
CONDITIONS
Official Title
Phase I Clinical Study of QLS-1304 in the Treatment of Patients With Advanced Malignant Tumors
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 score of 0-1
- Expected survival of at least 12 weeks
- Confirmed local recurrent or metastatic advanced malignant solid tumor by histopathology or cytopathology
- Failed standard treatment or no standard treatment available
- At least one measurable lesion based on RECIST v1.1 criteria
- Normal functioning of important organs as required by the study
- Female participants with fertility and male participants must agree to use highly effective contraception during treatment and for 180 days after last dose
- Female participants with fertility must have a negative serum HCG test within 7 days before first dose and not be breastfeeding
- Willing and able to follow clinical visits and study procedures and have signed informed consent
You will not qualify if you...
- Received live or attenuated live vaccines within 4 weeks before first dose
- Major organ surgery within 4 weeks before first dose
- 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
- Other active malignant tumors within 5 years before first dose
- Brain metastases and/or carcinomatous meningitis or leptomeningeal disease
- Active tuberculosis, radiation pneumonitis, drug-induced pneumonitis, pulmonary fibrosis, or severe lung impairment
- Unable to swallow tablets or have gastrointestinal issues affecting drug absorption
- History of severe cardiovascular or cerebrovascular disease within 6 months before first dose
- Uncontrolled hypertension despite treatment with multiple antihypertensive 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
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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