Actively Recruiting
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2023-04-21
150
Participants Needed
1
Research Sites
220 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the study is to evaluate safety, pharmacokinetics,immunogenicity and efficacy of QLS31903 alone in the treatment of advanced cancer.
CONDITIONS
Official Title
A Study Evaluates the Safety, Pharmacokinetics, Immunogenicity and Efficacy of QLS31903 in Advanced Solid Tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and weight 40 kg or heavier
- Histologically or cytologically confirmed advanced solid tumor
- For Phase 1b, tumor must be GPC3 positive
- Standard treatment has failed, is not tolerated, or no standard treatment exists
- Adequate liver, blood, and kidney function
You will not qualify if you...
- Anti-tumor treatment within 4 weeks before first QLS31903 dose except specific conditions
- Participation in another clinical trial within 4 weeks before first QLS31903 dose
- Receipt of live or live attenuated vaccine within 30 days before first QLS31903 dose
- Prior treatment targeting GPC3
- Positive for HBsAg/HBcAb with HBV-DNA >10,000 copies/mL or positive for HCV-Ab with HCV-RNA >1,000 copies/mL
- Central nervous system metastasis except stable asymptomatic or treated symptomatic brain metastases for more than 4 weeks
- Carcinomatous meningitis or leptomeningeal disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan Zhongshan Hospital
Shanghai, Shanghai Municipality, China, 200000
Actively Recruiting
Research Team
Y
Yan Chen, PhD
CONTACT
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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