Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nab-paclitaxel+ Gemcitabine · 1 trial · 3 indications
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 |
|---|---|---|
| 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 |
| Name | Type | Description |
|---|---|---|
| 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. |
Inclusion Criteria: * Written informed consent obtained prior to initiating any trial-specific procedures or assessments. * Male or female patients aged 18 years or over. * Patients with histologically or cytologically confirmed pancreatic adenocarcinoma that is metastatic (stage IV) at diagnosis a...
Nab-paclitaxel is being studied in combination with gemcitabine for the treatment of metastatic pancreatic adenocarcinoma and metastatic pancreas cancer. It is an investigational small molecule in Phase 2 clinical development for these indications, evaluated in patients with newly diagnosed metastatic disease.
Nab-paclitaxel is a small molecule that targets microtubules, which are essential components of cell division. By stabilizing microtubules, it disrupts cancer cell proliferation. This mechanism is being evaluated in combination with gemcitabine for metastatic pancreatic cancer in clinical trials.
Nab-paclitaxel is being developed by Theriva Biologics, Inc., a company traded under the ticker TOVX. The company is conducting clinical trials to evaluate the drug in combination with gemcitabine for the treatment of metastatic pancreatic cancer.
Nab-paclitaxel is in Phase 2 clinical development for metastatic pancreatic adenocarcinoma. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and an additional Phase 1 trial is currently recruiting participants.
Nab-paclitaxel is being evaluated in two clinical trials. NCT05673811 is a completed Phase 2 study of nab-paclitaxel and gemcitabine plus or minus VCN-01 in metastatic pancreatic cancer with 112 participants. NCT07701486 is a recruiting Phase 1 study of more frequent VCN-01 dosing combined with standard chemotherapy in newly diagnosed metastatic pancreatic cancer.
Nab-paclitaxel is the same as Nab-paclitaxel + Gemcitabine when used in combination therapy. The drug is studied as part of a regimen that includes gemcitabine, and this combination is referred to as Nab-paclitaxel + Gemcitabine in clinical trial contexts for pancreatic cancer treatment.