Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer

  • STATUS
    Recruiting
  • End date
    Mar 1, 2024
  • participants needed
    50
  • sponsor
    Lokon Pharma AB
Updated on 24 April 2022
platelet count
paclitaxel
cancer
measurable disease
carcinoma
residual tumor
combination chemotherapy
metastasis
oxaliplatin
neutrophil count
gemcitabine
bevacizumab
gene therapy
cancer chemotherapy
systemic chemotherapy
parp inhibitor
fallopian tube
ovarian carcinoma
primary peritoneal carcinoma
peritoneal carcinoma
ovarian epithelial carcinoma
cancer of the ovary

Summary

This Phase I/II trial evaluates LOAd703 in patients with cancer (pancreatic, biliary, colorectal or ovarian) together with their standard of care chemotherapy or using gemcitabine immune-conditioning. LOAd703 is administered by intratumoral image-guided injections. Maximum 50 patients can be enrolled.

LOAd703 is an immunostimulatory gene therapy using an selection replication competent adenovirus as a gene vehicle. The virus is derived from serotype 5 adenovirus with the fiber from serotype 35. It expresses the transgenes trimerized membrane-bound isoleucine zipper (TMZ) TMZ-CD40L and 41BBL under control of a cytomegalovirus (CMV) promoter.

Description

The trial is a Phase I/II trial evaluating the effect of LOAd703 in patients with pancreatic cancer, biliary cancer, ovarian cancer and colorectal cancer. LOAd703 is an oncolytic adenovirus serotype 5/35 encoding immunostimulatory transgenes: TMZ-CD40L and 41BBL. In Phase I, three doses (total viral load - 1x10e11, 5x10e11, 1x10e12 viral particles (VP)) of LOAd703 will be tested as add-on to standard of care or immune-conditioning gemcitabine chemotherapy. 8 treatments of LOAd703 will be delivered by image-guided intratumoral injection at the same time of chemotherapy. In Phase II stage of the study, patients will be treated at maximum tolerated dose/maximum tolerated study dose as defined in the Phase I stage. In both phases: tumor biopsies, blood samples and radiological imaging will be performed to evaluate safety, effect and mechanisms of action. Further, patients will be subjected to oral and rectal swabs, and urine sampling to determine virus shedding. The patients will be monitored for time to progression, progression free survival and overall survival.

Details
Condition Pancreatic Adenocarcinoma, Ovarian Cancer, Biliary Carcinoma, Colorectal Cancer
Treatment LOAd703
Clinical Study IdentifierNCT03225989
SponsorLokon Pharma AB
Last Modified on24 April 2022

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