OncoMatch/Clinical Trials/NCT06346041
Safety and Efficacy of Intravenous IDOV-SAFETM in Patients With Advanced Solid Tumors
Is NCT06346041 recruiting? Yes, currently enrolling (May 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
Performance status
ECOG 0–1(Restricted strenuous activity)
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.
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