Actively Recruiting
Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors
Led by Cancer Institute and Hospital, Chinese Academy of Medical Sciences · Updated on 2025-02-04
19
Participants Needed
1
Research Sites
102 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 or MFD, pharmacokinetic profile, immunogenicity, and pharmacodynamic profile of IDOV-SAFETM in patients with advanced solid tumors.
CONDITIONS
Official Title
Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Understand and voluntarily sign a written informed consent
- Male and female, 18 years old and older up to 75 years old
- Histologically or cytologically confirmed advanced malignant solid tumors unresponsive to standard treatment or lacking effective standard treatment
- ECOG physical status score of 0 or 1
- Expected survival of 3 months or more
- At least one evaluable lesion according to RECIST version 1.1
- Adequate blood counts and bone marrow function within 7 days prior to dosing
- Liver function within specified limits depending on metastasis status
- Renal function with serum creatinine ≤1.5 times upper limit or creatinine clearance ≥60 ml/min
- Coagulation function within defined limits
- Negative pregnancy test for fertile females within 7 days prior to dosing
- Willingness to use effective contraception during the trial and for 90 days after last dose for both males and females
You will not qualify if you...
- Severe systemic reactions to prior smallpox vaccination
- Known allergy to the test drug or its excipients
- History of other tumors within 5 years, except certain low-risk or treated cancers
- Untreated symptomatic central nervous system metastases, except stable or asymptomatic cases
- Pial metastasis
- Uncontrolled pleural, pericardial effusion, or ascites requiring repeated drainage
- Prior treatment with oncolytic viruses, stem cells, or gene therapies
- Systemic antitumor therapy within 4 weeks or certain targeted drugs within 2 weeks before dosing
- Unresolved adverse reactions from prior antitumor therapy above grade 1
- Recent surgery, interventional treatment, or unhealed wounds within 4 weeks prior to dosing
- Severe cardiovascular or cerebrovascular disease or poorly controlled hypertension
- Severe exfoliative skin conditions requiring systemic treatment
- Active hepatitis B or C, HIV infection
- Active infection or unexplained fever above 38.5°C during screening
- Clinically significant immunodeficiency or opportunistic infections
- Active or history of autoimmune diseases, except some controlled exceptions
- Long-term systemic steroid or immunosuppressant use within 14 days prior to treatment
- Previous allogeneic tissue or solid organ transplantation
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences
Beijing, China
Actively Recruiting
Research Team
N
Ning Li, MD
CONTACT
S
Shuhang 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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