Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as VCN-01 oncolytic adenovirus (zabilugene almadenorepvec), VCN-01 oncolytic adenovirus
VCN-01 · 5 trials · 10 indications
From date of randomization until the date of death from any cause, assessed up to 27 months
Safety and tolerability of VCN-01, IV administered at Week 1 and Week 14 in Arm 2 measured as incidence of Adverse Events as assessed by CTCAE v5.0
Frequency and proportion of participants experiencing AEs/SAEs; descriptive statistics for laboratory values.
VCN-01 concentration in blood at predefined time points.
| Arm | Type | Description |
|---|---|---|
| Arm 1-SoC | ACTIVE_COMPARATOR | Nab-paclitaxel and gemcitabine as SoC. |
| Arm 2 -VCN-01 + SoC | EXPERIMENTAL | A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC. |
| High dose | EXPERIMENTAL | The initial dosing regimen for this study comprises three "macrocycles", each of which comprises one dose of VCN-01 followed one week later by 2 cycles of GnP according to standard of care |
| Cohort 1 | ACTIVE_COMPARATOR | Single dose of 3.3x10(12) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort 2 | ACTIVE_COMPARATOR | Single dose of 1x10(13) vp of VCN-01 on Day 0, followed by a single dose of 5x10(7) of huCART-meso cells on Day 14. |
| Cohort -1 | ACTIVE_COMPARATOR | In the event that 2 DLTs occur in Cohort 1, then enrollment in Cohort 1 will be stopped and Cohort -1 will be opened for evaluation. Enrolled subjects will receive a single dose of huCART-meso cells on Day 0 followed by a single dose of 3.3x10(12) vp of VCN-01 on Day 14. |
| Dose Escalation, Combination | EXPERIMENTAL | Three intratumoral administrations of VCN-01 oncolytic adenovirus every 28 days in combination with Abraxane® and Gemcitabine. |
| Part I: Dose Escalation, Single Agent | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus |
| Part II: Dose Escalation, Combination | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
| Part III: Dose Escalation, Combination, "delayed" schedule | EXPERIMENTAL | Single intravenous injection of VCN-01 oncolytic adenovirus in combination with Abraxane®/Gemcitabine |
| Name | Type | Description |
|---|---|---|
| Nab-paclitaxel | DRUG | Nab-paclitaxel administered as an IV infusion at a rate of 125 mg/m2. Nab-paclitaxel is administered on Day 1, Day 8 and Day 15 of each 28-day cycles. |
| Gemcitabine | DRUG | Gemcitabine administered as an IV infusion at a dose of 1,000 mg/m2 immediately after the completion of nab-paclitaxel administration as part of SoC. Gemcitabine is administered on Day 1, Day 8 and Day 15 of each 28-day cycles. |
| VCN-01 | GENETIC | VCN-01 administrated as a single IV infusion at dose 1xE13 viral particles (vp) on Day 1 of the 1st cycle and then again on Day 1 of the 4th cycle (Day 92). On cycle 1 and cycle 4, nab-paclitaxel and gemcitabine administered on Day 8, Day 15 and Day 22. |
| VCN-01 oncolytic adenovirus (zabilugene almadenorepvec) | BIOLOGICAL | The initial dosing regimen for this study comprises up to three "macrocycles", each of which comprises one dose of VCN-01 followed one week later by 2 cycles of GnP according to standard of care (SoC) |
| Nab-paclitaxel + Gemcitabine | DRUG | IV nab-paclitaxel (starting dose 125 mg/m²) followed by IV gemcitabine (starting dose 1,000 mg/m²) according to SoC clinical practice (GnP SoC). Dose modifications and interruptions permitted per prescribing information/SmPC. |
| huCART-meso Cells | BIOLOGICAL | Intravenous administration of huCART-meso cells |
| Abraxane® | DRUG | 125 mg/m2 intravenous administration |
Inclusion Criteria: 1. Written informed consent obtained prior to any study-specific procedures or assessments. 2. Male/female patients aged 18 years or over. 3. Patients with histologically or cytologically confirmed, first line metastatic pancreatic adenocarcinoma stage IV de novo, who never rece...
VCN-01 is an investigational oncolytic adenovirus developed by Theriva Biologics, Inc. (TOVX) as a gene therapy for cancer. It is being studied in locally advanced and metastatic solid tumors, with the main clinical focus on pancreatic cancer, including metastatic pancreatic adenocarcinoma. It is not an approved product and remains in clinical development.
VCN-01 is being studied for pancreatic cancer, particularly metastatic pancreatic adenocarcinoma and newly diagnosed metastatic pancreatic ductal adenocarcinoma. Trials combine it with standard chemotherapy regimens such as nab-paclitaxel and gemcitabine, and one study pairs it with huCART-meso cells in pancreatic and ovarian cancer. All use remains investigational.
VCN-01 is developed by Theriva Biologics, Inc., which trades under the ticker TOVX. The company sponsors the clinical program evaluating the agent in pancreatic cancer and other advanced solid tumors across studies in the United States and Spain.
VCN-01 is in Phase 1 and Phase 2 clinical development. The Phase 2 study of nab-paclitaxel and gemcitabine with or without VCN-01 in metastatic pancreatic cancer has completed, while a Phase 1 study of more frequent VCN-01 dosing with standard chemotherapy in newly diagnosed metastatic pancreatic cancer is recruiting.
VCN-01 trials include NCT07701486, a recruiting Phase 1 study of more frequent dosing with standard chemotherapy in newly diagnosed metastatic pancreatic cancer in Spain, and NCT05673811, a completed Phase 2 study with nab-paclitaxel and gemcitabine. NCT05057715 tested huCART-meso plus VCN-01, and NCT02045602 was an intravenous dose escalation study.
Yes. VCN-01 is also known as zabilugene almadenorepvec, and it is described as a VCN-01 oncolytic adenovirus. These names refer to the same investigational gene therapy developed by Theriva Biologics for solid tumors and pancreatic cancer.