A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors

QLS1103-101

This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.

2023-06-30

2025-01-30

2025-07-30

Recruiting

Early phase I

148

Inclusion Criteria: * 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form; * 2. Aged ≥18 years old; * 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor; * 4. Failure of adequate standard treatment, or no effective standard treatment; * 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1; * 6. Life expectancy ≥12 weeks; Exclusion Criteria: * 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose; * 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose; * 3. Subjects received major surgery within 4 weeks prior to the first dose; * 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy; * 5. Cardiovascular and cerebrovascular diseases with clinical significance; * 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SEQUENTIAL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 148, 'type': 'ESTIMATED'}}

2023-08-01