Table 2.
Clinical trials of OVs
| Virus | Disease | Modification | Intervention/treatment | Phase | Number enrolled | dosage-regimen | Primary outcome measure | Secondary outcome measure | Status | NCT number |
|---|---|---|---|---|---|---|---|---|---|---|
| Adenovirus | Malignant Solid Tumor | Armed with granulocyte-macrophage colony stimulating factor (GMCSF) | CGTG-102 | I | 12 |
Intratumoral intravenous |
Safety and tolerability; Dose Limiting Toxicities (DLT) |
Response rate; disease control rate; progression free and overall survival | Completed | NCT01598129 |
|
Ovarian Cancer; Primary peritoneal cancer |
E1A gene deletion. RGD motif binds to integrins avb3 and avb5 | Ad5-delta24RGD | I | 26 | Intraperitoneal |
Maximum tolerated dose (MTD); Spectrum of toxicities |
Biologic, immunologic and anti-tumor effects of Ad5-delta24RGD | Completed | NCT00562003 | |
| Recurrent platinum resistant ovarian cancer | Developed through a process of bio-selection | Enadenotucirev | I | 38 | Intravenous | Maximum tolerated dose (MTD) | Completed | NCT02028117 | ||
| Pancreatic cancer | Encoding TMZ-CD40L and 4-1BBL(LOAd-703) |
LOAd-703; Gemcitabine; nab-paclitaxel; atezolizumab |
I/ II | 43 | Intratumoral | Number of patient with dose-limiting toxicities (DLTs) |
Overall Response Rate; Overall Survival |
Recruiting | NCT02705196 | |
| Reovirus | Metastatic Breast Cancer | No modification | Paclitaxel Reolysin | II | 81 | Intravenous | Progression free survival | Response rate; Tumor and tissue response of potential molecular factors; Number of patients with adverse events | Completed | NCT01656538 |
| Herpes Simplex Virus | Solid tumor | A spontaneously attenuated mutant | TBI-1401(HF10) | I | 6 | Intratumoral | Safety and tolerability |
Overall tumor response; Levels of antibody to HSV-1 |
Completed | NCT02428036 |
| Brain tumors | Deletion of both copies of the γ1 34.5 gene and a disabling lacZ insertion in UL39 gene (G207) | G207 | I | 15 | Intratumoral | Safety and tolerability |
Progression Free Survival; Overall Survival |
Recruiting | NCT03911388 | |
| Rhabdomyosarcoma; Osteosarcoma and other | RL1 gene deletion | HSV1716 | I | 18 |
Intravenous; Intratumoral |
Safety of intratumoral injection or intravenous infusions | Antiviral immune response | Completed | NCT00931931 | |
| Pancreatic cancer | Oncolytic Type 2 Herpes Simplex Virus Expressing Granulocyte Macrophage Colony-Stimulating Factor(OH2) | OH2 | I/ II | 25 | Intratumoral | The objective response rate |
Safety; The disease control rate; The duration of response; The progression free survival; |
Recruiting | NCT04637698 | |
| Vaccinia Virus | Advanced solid tumor | Encoding Renilla luciferase-Aequorea green fluorescent protein fusion, β-galactosidase, and β-glucuronidase | GL-ONC1 | I | 43 | Intravenous | Safety and tolerability |
Detection of virus delivery to primary and/or metastatic tumors; Evaluation of anti-vaccinia virus immune response; Determine recommended dose and schedule for future investigation |
Completed | NCT00794131 |
| Hepatocellular Carcinoma (HCC) |
Thymidine Kinase deletion; Arm with GM-CSF |
JX-594 | II | 30 | Intratumoral | Proportion of Subjects Achieving Disease Control; |
Safety and tolerability; Number of Subjects Achieving Disease Control; Median Overall Survival |
Completed | NCT00554372 | |
| Hepatocellular Carcinoma (HCC) |
Thymidine Kinase deletion; Arm with GM-CSF |
Pexastimogene Devacirepvec (Pexa Vec/JX-594) Sorafenib | III | 459 | Intratumoral | Overall Survival; Overall Response Rate (ORR); |
Time to Progression (TTP); Progression Free Survival (PFS); Overall Response Rate (ORR); Disease Control Rate (DCR); Incidence of Adverse Events (AE); Serious Adverse Events (SAE); Time to Symptomatic Progression (TSP) |
Completed | NCT02562755 | |
| Measles virus | Ovarian cancer |
Expressing carcinoembryonic antigen(MV-CEA) Encoding thyroidal sodium iodide symporter (MV-NIS) |
MV-CEA, MV-NIS | I | 37 | Intraperitoneally |
Dose limiting Toxicity (DLT); Maximum tolerated dose (MTD) |
Number of Responses; CA-125 levels; Time to Progression |
Completed | NCT00408590 |