Actively Recruiting
A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors
Led by Zhejiang University · Updated on 2025-01-16
44
Participants Needed
1
Research Sites
157 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial is a multi-center, open-label investigator-initiated clinical study (IIT) to evaluate the safety, pharmacokinetics, pharmacodynamics and effectiveness of WTX212A injection in the treatment of patients with unresectable or metastatic advanced solid tumors who failed in previous systematic therapy. The study was divided into two phases: dose escalation and dose expansion
CONDITIONS
Official Title
A Dose Escalation and Dose Expansion Trial of WTX212A in the Treatment of Patients with Advanced Malignant Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must sign an informed consent form, understand the study, and be able to complete all procedures
- Aged 18 to 75 years old (inclusive)
- Diagnosed with unresectable or metastatic solid tumors that have failed systemic treatment or lack effective standard treatment, or are unwilling or unsuitable for standard treatment
- ECOG performance status of 0 or 1
- Expected life expectancy of at least 3 months
- Agree to use effective contraception from consent signing until 3 months after last treatment (for males and females of childbearing potential)
- Women of childbearing age must have a negative pregnancy test within 7 days before first treatment
You will not qualify if you...
- Serious medical diseases such as uncontrolled diabetes, active peptic ulcer, active bleeding, or serious cardiovascular diseases
- Presence of pleural or ascitic fluid requiring repeated drainage
- History of pulmonary fibrosis, severe lung damage from pneumoconiosis, radiation pneumonia, or drug-related pneumonia
- History of adverse events requiring permanent cessation of immune-oncology treatment
- Known other malignant tumors currently progressing or treated within past 3 years
- Symptomatic central nervous system metastases unstable within 14 days requiring steroid treatment
- Hereditary bleeding disorders or history of thrombosis, hemolysis, or hemorrhagic diseases
- Significant surgery or major injury within 28 days before starting study treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
the First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Q
Qi Zhang, M.D.
CONTACT
Q
Qihan Fu, M.D.
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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