Actively Recruiting
Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors
Led by Fudan University · Updated on 2025-02-06
38
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is an open-label, dose escalation, phase I study to evaluate safety tolerability, MTD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of Intravenous Administration of IDOV-SAFETM in patients with advanced solid tumors.
CONDITIONS
Official Title
Study on the Safety and Efficacy of Intravenous Administration of IDOV-SAFETM in the Treatment of Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 18 to 75 years old
- Have at least one measurable target tumor lesion at screening
- Diagnosed with advanced solid tumors that have failed standard therapy
- ECOG physical strength score of 0 or 1 at screening
- Life expectancy of at least 3 months
- Adequate organ function including bone marrow, liver, and kidney as specified
- Fertile female participants must have a negative blood beta-HCG test within 7 days before enrollment
- Agree to use highly effective contraception from the start of consent to study end
- Fully informed and voluntarily sign informed consent form
You will not qualify if you...
- Untreated asymptomatic brain metastases or symptomatic central nervous system metastases or cancerous meningitis
- Severe chronic or active infections including active hepatitis B or C, HIV infection, or requiring systemic anti-infective treatment within 4 weeks prior to study drug
- History of active autoimmune diseases or recent use of systemic steroids or immunosuppressants within 4 weeks before first dose
- History of allogeneic tissue or organ transplantation
- Evidence of clinically significant immunodeficiency
- Use of anticoagulant or antiplatelet drugs that cannot be safely stopped before injection
- History of severe cardiovascular or cerebrovascular diseases including heart failure, low heart function, prolonged QT interval, recent acute coronary syndrome, stroke, or uncontrolled hypertension
- Treatment with chemotherapy, radiotherapy, biotherapy, endocrine therapy, or immunotherapy within 4 weeks prior to first dose
- Other diseases or conditions judged by investigator as unsuitable
- Vaccination against smallpox or monkeypox within 10 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, China
Actively Recruiting
Research Team
J
Jianhua Chen, PhD
CONTACT
H
Hongxia Wang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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