Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nab-paclitaxel · 1 trial · 2 indications
Time from randomization until death in both arms
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
| 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. |
| 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. |
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...
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.