OncoMatch/Clinical Trials/NCT06346041
Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors
Is NCT06346041 recruiting? Yes, currently enrolling (Jun 2026). This Early Phase 1 trial studies Oncolytic Virus for neoplasms.
Treatment: Oncolytic Virus — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: oncolytic virus
Previous acceptance of oncolytic viruses
Cannot have received: stem cell therapy
Previous acceptance of stem cells
Cannot have received: gene therapy
Previous acceptance of gene therapy products
Cannot have received: systemic antitumor therapy
Exception: within 4 weeks before the first dose
Patients with received systemic antitumor therapy, including but not limited to chemotherapy, endocrine therapy, and immunotherapy, within 4 weeks before the first dose
Cannot have received: oral small-molecule targeted drug
Exception: administered 2 weeks before the first dose or within 5 half-lives of the drug (whichever is longer)
Oral small-molecule targeted drugs are administered 2 weeks before the first dose or within 5 half-lives of the drug (whichever is longer)
Cannot have received: palliative radiotherapy
Exception: within 14 days before the first dose
Palliative radiotherapy within 14 days before the first dose
Cannot have received: other antitumor drug (clinical trial)
Exception: participated in clinical trials of other antitumor drugs within 4 weeks
Participated in clinical trials of other antitumor drugs within 4 weeks
Cannot have received: Chinese herbal medicine or proprietary Chinese medicine for anti-tumor indication
Exception: within 2 weeks prior to initial administration
Received any Chinese herbal medicine or proprietary Chinese medicine for any anti-tumor indication within 2 weeks prior to initial administration
Cannot have received: surgery or interventional treatment (excluding tumor biopsy, puncture, etc.)
Exception: within 4 weeks prior to the first dose
Patients with received surgery or interventional treatment (excluding tumor biopsy, puncture, etc.) or unhealed wounds, ulcers or fractures within 4 weeks prior to the first dose
Lab requirements
Blood counts
neutrophils ≥1.5×10^9/L, platelets >100×10^9/L, hemoglobin ≥90g/L (no blood transfusion, no supportive treatment with G-CSF and other drugs within 2 weeks before screening)
Kidney function
serum creatinine ≤1.5× ULN or creatinine clearance CCr ≥60 ml/min (Cockcroft-Gault formula)
Liver function
ALT and/or AST ≤3× ULN; total bilirubin ≤1.5× ULN; for patients with liver metastasis: ALT and/or AST ≤5× ULN
Cardiac function
LVEF <50% excluded; QTcF >470ms excluded; congestive heart failure ≥ Class II NYHA; acute coronary syndrome, aortic dissection, severe arrhythmia, stroke, or other grade 3 or higher cardiovascular/cerebrovascular events within 6 months before first treatment; hypertension poorly controlled by standard treatment (systolic BP ≥140mmHg or diastolic BP ≥90mmHg)
Major organ and bone marrow functions meet the following criteria within 7 days prior to initial dosing: ... see full criteria for details
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06346041 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior oncolytic virus, stem cell therapy, gene therapy disqualifies patients from enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify