OncoMatch/Clinical Trials/NCT06126510
Clinical Study of VG161 in the Treatment of Advanced Bone and Soft Tissue Sarcoma
Is NCT06126510 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 for sarcoma.
Treatment: Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 — This study plans to use 1.0×108PFU/day per cycle, intratumoral injection administration for 3 consecutive days, and 28 days as a cycle. Tumor imaging evaluation was performed every 8±1 weeks from the first dose of C1D1 until an event that met the criteria for treatment discontinuation occurred.
Check if I qualifyExtracted eligibility criteria
Cancer type
Sarcoma
Biomarker criteria
Required: HSV1 positive IgG or IgM antibody test
Those who have a positive HSV-1 IgG or HSV-1 IgM antibody test result (HSV-1 IgM).
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard treatment
have failed at least one standard treatment (among them, patients with Ewing sarcoma need to be patients without standard treatment)
Cannot have received: chemotherapy
Exception: within 4 weeks before the first use of study drugs
Have received chemotherapy...within 4 weeks before the first use of study drugs
Cannot have received: radiotherapy
Exception: within 4 weeks before the first use of study drugs
Have received...radiotherapy...within 4 weeks before the first use of study drugs
Cannot have received: biological therapy
Exception: within 4 weeks before the first use of study drugs
Have received...biological therapy...within 4 weeks before the first use of study drugs
Cannot have received: endocrine therapy
Exception: within 4 weeks before the first use of study drugs
Have received...endocrine therapy...within 4 weeks before the first use of study drugs
Cannot have received: targeted therapy
Exception: within 4 weeks before the first use of study drugs; oral fluorouracils and small molecule targeted drugs: within 2 weeks or 5 half-lives (whichever is longer)
Have received...targeted therapy...within 4 weeks before the first use of study drugs, among which oral fluorouracils and small molecule targeted drugs...within the first 2 weeks or the 5 half-lives of the drug (whichever is longer)
Cannot have received: immunotherapy
Exception: within 4 weeks before the first use of study drugs
Have received...immunotherapy...within 4 weeks before the first use of study drugs
Cannot have received: other anti-tumor drugs
Exception: within 4 weeks before the first use of study drugs
Have received...other anti-tumor drugs within 4 weeks before the first use of study drugs
Cannot have received: unmarketed clinical trial treatments
Exception: within 4 weeks before using the study drug for the first time
Have received other unmarketed clinical trial treatments within 4 weeks before using the study drug for the first time
Lab requirements
Blood counts
ANC≥1.5×10^9/L, PLT≥75×10^9/L, Hb≥85g/L, lymphocyte count≥1.5×10^9/L (0.8–1.5×10^9/L at investigator discretion)
Kidney function
Cr≤1.5×ULN, and creatinine clearance ≥45ml/min (Cockcroft-Gault formula)
Liver function
TBIL ≤1.5×ULN, ALT≤3×ULN, AST≤3×ULN (ALT≤5×ULN and AST≤5×ULN are acceptable for patients with liver metastases)
Cardiac function
QTc interval>480ms, NYHA class ≥II or LVEF<40%, uncontrolled hypertension (SBP≥140mmHg or DBP≥90mmHg after treatment), ventricular arrhythmias requiring intervention, acute coronary syndrome, CHF, stroke or other grade III+ cardiovascular events within 6 months
Have adequate organ function: Blood routine...Liver function...Renal function...Coagulation function...History of severe cardiovascular disease...
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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