CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 47 enrolled
Drug / intervention
LOAd703drug
Likely dose
LOAd703 oncolytic adenovirus (dose not specified in published record)AI-extracted
Key inclusion· 8
  • Histologically or cytologically confirmed colorectal carcinoma, pancreatic carcinoma, biliary cancer, or epithelial ovarian carcinoma
  • Advanced disease: metastatic or locally advanced/unresectable, not amenable to radiotherapy or locoregional therapies
  • Low tumor burden defined as sum of product of bidimensional measurements <70 cm2
  • At least one non-irradiated lesion (or irradiated with documented progression) suitable for image-guided intratumoral injection and needle biopsy
Key exclusion· 7
  • Active, severe autoimmune disease
  • Known active hepatitis B or C, or HIV infection
  • Warfarin or other anticoagulants
  • Treatment within 21 days with high-dose immune inhibitors, lymphotoxic monoclonal antibodies, biological therapy, cytotoxic agents, or investigational agents

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03225989
NCT03225989Phase 2Completed

Phase I/II Trial Investigating an Immunostimulatory Oncolytic Adenovirus for Cancer

Lokon Pharma AB·interventional·Posted Jul 21, 2017·Updated Nov 19, 2024

In Brief

A Phase 2 clinical trial evaluating LOAd703 for Pancreatic Adenocarcinoma and 3 related conditions. Completed, enrolled 47 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSweden
CollaboratorsUppsala University

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedJul 21, 2017
Enrollment StartMar 1, 2018
Primary CompletionAug 22, 2023
TodayJul 2, 2026
Enrollment to primary: 5.5 yearsPosted 8.9 years ago

Interventions

LOAd703drug

Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL