Arm 2 -VCN-01 + SoC for Pancreatic Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
University of Lousville - Brown Cancer Center, Louisville, KYPancreatic Adenocarcinoma+1 MoreGemcitabine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug combo to treat pancreatic cancer in patients who have advanced disease.

Eligible Conditions
  • Pancreatic Adenocarcinoma
  • Metastatic Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: 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.

Year 3
Radionics
Tumor growth
Year 3
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.
Year 3
Disease Control Rate (DCR) to subsequent therapies
Month 1
Immune markers
PH20 levels in serum
VCN-01 genomes levels in blood
Year 3
Neutralizing anti-VCN-01 antibodies (Anti-Ad-Nabs)
From randomization to 1-year landmark
1-year survival
Year 3
Duration of Response (DoR)
From randomization to1-year landmark
Progression Free Survival (PFS) at the 1-year landmark
Year 3
Disease Control Rate (DCR)
Overall Response Rate (ORR)
Overall Survival
Year 3
Changes in tumor marker Ca 19.9
Incidence of Adverse Events after VCN-01 IV administration
Time to progression (TTP) or Progression Free Survival (PFS)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Arm 1-SoC
1 of 2
Arm 2 -VCN-01 + SoC
1 of 2

Active Control

Experimental Treatment

96 Total Participants · 2 Treatment Groups

Primary Treatment: Arm 2 -VCN-01 + SoC · No Placebo Group · Phase 2

Arm 2 -VCN-01 + SoCExperimental Group · 3 Interventions: Gemcitabine, VCN-01, Nab-paclitaxel · Intervention Types: Drug, Genetic, Drug
Arm 1-SoCActiveComparator Group · 2 Interventions: Gemcitabine, Nab-paclitaxel · Intervention Types: Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Gemcitabine
2017
Completed Phase 3
~2070
VCN-01
2014
Completed Phase 1
~50
Nab-paclitaxel
2014
Completed Phase 3
~1680

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 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.

Who is running the clinical trial?

Theriva Biologics SLLead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
VCN Biosciences, S.L.Lead Sponsor
4 Previous Clinical Trials
82 Total Patients Enrolled
Mary Ann Shallcross, PhDStudy ChairTheriva Biologics, Inc.
Carmen Blasco, PhDStudy ChairVCNBiosciences SL

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are expected to live for at least 5 more months.

Frequently Asked Questions

Has the combination of Arm 2 -VCN-01 and Standard of Care been accepted by the U.S. Food & Drug Administration?

"Our team have given Arm 2 -VCN-01 + SoC a score of two due to the preclinical evidence confirming its safety, but no efficacy data being available yet as this is only in Phase 2." - Anonymous Online Contributor

Unverified Answer

Are there any current opportunities to participate in this clinical trial?

"The information on clinicaltrials.gov indicates that patient recruitment for this trial has ceased. Initially posted on October 10th 2023, the last update to the study was made on March 1st of the same year; however, there are currently 777 other studies seeking participants." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.