A Phase 2 interventional study of Nab-paclitaxel and Gemcitabine in Pancreatic Adenocarcinoma and Metastatic, sponsored by Theriva Biologics SL. Completed at 17 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-16.
Sponsored by Theriva Biologics SL · Phase 2, Interventional, and Treatment
A phase IIb, open-label, randomized study of Nab-Paclitaxel and Gemcitabine and plus/minus VCN-01 in Patients with Metastatic Pancreatic Cancer
Multi-center, open label, randomized, 2-parallel arm, phase IIb study of nab-paclitaxel and gemcitabine as Standard of Care (SoC) plus/minus VCN-01 in patients with metastatic pancreatic cancer. Gemcitabine and nab-paclitaxel are chemotherapy drugs approved by the FDA to treat pancreatic cancer. VCN-01 is a genetically modified adenovirus characterized by the presence of four independent genetic modifications in the backbone of the wild-type human adenovirus serotype 5 (HAd5) genome that confer tumor selective replication and antitumor activity. Approximately 92 patients in sites in North America and European Union (EU) will be recruited and randomized in a 1:1 ratio to one of two treatment arms (i.e., approximately 46 patients per treatment arm):
A Data Monitoring Committee (DMC) will be convened at regular intervals to assess safety and to look at OS to determine if the trial can continue.
2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.
This study's enrollment of 112 is above the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.
Browse Adenocarcinoma studies →Theriva Biologics SL is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Adequate baseline organ function (hematologic, liver, renal and nutritional)verified by laboratory analyses performed within 72 hours prior to dosing*:
Hematology:
Coagulation (*except in patients on anticoagulants):
Hepatic:
Renal:
Nutritional:
Exclusion Criteria:
<!-- -->
Active infection or other serious illness or autoimmune disease at the moment of randomization. Active infection includes tuberculosis (TB; clinical evaluation that includes clinical history, physical examination and radiographic findings, and TB testing in line with local practice), Hepatitis B Virus (HBV; positive HBV surface antigen [HBsAg] result), Hepatitis C Virus (HCV; positive HCV Ribonucleic acid [RNA]), or human immunodeficiency virus (positive HIV 1/2 antibodies). HBV carriers (patients positive for HBsAg) or those patients requiring antiviral therapy treatment for HBV virus or HCV are not eligible to participate.
However, the following patients are eligible to participate in the study:
o Patients with past or resolved TB are eligible;
o Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [HBcAb] and absence of HBsAg) are eligible. Blood HBV DNA must be obtained and must be negative in these patients prior to treatment;
o Patients positive for HCV antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
Nab-paclitaxel and gemcitabine as SoC.
Drug: Nab-paclitaxel · Drug: Gemcitabine
A maximum of two (2) doses of VCN-01 administrated as a single IV infusion in combination with nab-paclitaxel and gemcitabine as SoC.
Drug: Nab-paclitaxel · Drug: Gemcitabine · Genetic: VCN-01
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 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 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.
Overall Survival
Time from randomization until death in both arms
Time frame: From randomization until death for any cause up to 3 years
Incidence of Adverse Events after VCN-01 IV administration
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
Time frame: From randomization until disease progression assessed up to 3 years
Time to progression (TTP) or Progression Free Survival (PFS)
Time frame: TTP: From randomization until disease progression assessed up to 3 years or death due to progression.PFS: From randomization to either progression or death from any cause.
Overall Response Rate (ORR)
Objective response rate (ORR) defined as the sum of patients who achieved partial response (PR) plus patients who achieved complete response (CR) using RECIST version 1.1 criteria.
Time frame: From randomization until death for any cause up to 3 years
Disease Control Rate (DCR)
Disease Control Rate (DCR) defined as: stable disease (SD) + partial response (PR) + complete response (CR)
Time frame: From randomization until death for any cause up to 3 years
Landmark 1-year survival
Time frame: From randomization to 1-year landmark
Progression Free Survival (PFS) at the 1-year landmark
Time from randomization to either progression or death from any cause.
Time frame: From randomization to1-year landmark
Duration of Response (DoR)
Time from the date of first documented response until date of documented disease progression or death in the absence of disease progression.
Time frame: From randomization to disease progression assessed up to 3 years
Changes in tumor marker Ca 19.9
Tumor marker Ca 19.9 measured every 4 weeks while on study
Time frame: From randomization until disease progression assessed up to 3 years
Neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs)
Determination of neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs) in serum of Arm 2 patients at different time-points during the study. Cycle 1 (VCN-01+SoC dosing): Pre-dose on day 1, day 8, and day 15; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose on day 1, day 8, and day 15; On Day 1 of any subsequent SoC cycle.
Time frame: From pre-dose up to 3 years
PH20 levels in serum
Determination of PH20 levels in serum of Arm 2 (VCN-01 + SoC) patients at the following time-points: Cycle 1 (VCN-01+SoC dosing): Pre-dose on day 1, 48h post-dose and on day 8; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose on day, 48h post-dose and on day 8; On Day 1 of any subsequent SoC cycle.
Time frame: From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
VCN-01 genomes levels in blood
Determination of VCN-01 genomes in whole blood of Arm 2 (VCN-01 + SoC) patients at the following time-points: Cycle 1 (VCN-01+SoC dosing): Pre-dose and 4h post-dose on day 1, 48h post-dose, on day 8 and day 15; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose and 4h post dose on day 1, 48h post-dose, on day 8 and day 15; On Day 1 of any subsequent SoC cycle.
Time frame: From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
Immune markers
Determination of immune markers in serum of Arm 1 (SoC) or Arm 2 (VCN-01 + SoC) patients at the following time-points: Arm 1: Cycle 1 (SoC): Pre-dose on day 1, day 8 and day 15. On Day 1 of any subsequent SoC cycle. Arm 2: Cycle 1 (VCN-01+SoC dosing): Pre-dose, 4h and 48h post-dose and on day 8; Cycle 2 (SoC dosing): Day 1; Cycle 3 (SoC dosing): Day 1; Cycle 4 (VCN-01+SoC dosing): Pre-dose, 4h and 48h post-dose, on day 8 and day 15; On Day 1 of any subsequent SoC cycle.
Time frame: From pre-dose to end of treatment defined as 1 month after the last dose of nab-paclitaxel/gemcitabine.
Radiomics
Change in radiomics assessed from the images of CT scans or MRI.
Time frame: Changes from baseline to every 8 week or every 4 weeks if there is a suspicion of Progressive Disease (PD) not radiologically confirmed during treatment and until disease progression up to 3 years.
Tumor growth
Change in tumor growth assessed from the images of CT scans or MRI.
Time frame: Changes from baseline to every 8 week or every 4 weeks if there is a suspicion of Progressive Disease (PD) not radiologically confirmed during treatment and until disease progression up to 3 years.
Changes in Quality of Life (QoL) via the validated Quality of Life Questionnaire of the European Organization for Research and Treatment of Cancer (EORTC QLQ-C30) version 3.
Changes in QoL assessed as the difference between QoL in day 1 of 1st treatment cycle (35 d) to QoL in day 1 of Cycle 2 (28d), to QoL in day 1 of Cycle 3 (28d), to QoL in day 1 of Cycle 4 (35d) and to QoL in day 1 of any subsequent SoC cycle (28d). Changes in QoL in EoT visit (1 month after last SoC treatment). Changes in QoL until disease progression in each monthly follow-up visit. After disease progression, changes in QoL in each monthly follow up visit during the first 6 months; changes in bimonthly follow-up visits up to to 2 years from progression and changes in each follow-up visit every 6 months onwards. The QoL scale ranges in score from 0 to 100, a high score represents a higher response level.
Time frame: From Day 1 in first treatment cycle (35-days) to last follow-up visit up to 3 years.
Disease Control Rate (DCR) to subsequent therapies
Disease Control Rate (DCR) defined as: stable disease (SD) + partial response (PR) + complete response (CR)
Time frame: From disease progression to exitus for any cause up to 3 years
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Theriva Biologics SL