A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma

Phase 1 Completed 14 enrolled Jennerex Biotherapeutics Green Cross Corporation · collab

Non-randomizedSingle-groupOpen-labelTreatment

Summary

The primary purpose of this study is to determine the maximum tolerable dose (MTD) and/or the maximum feasible dose (MFD), as well as to evaluate the safety of JX-594 (Pexa-Vec) injected within hepatic carcinoma tumors.

Timeline

Start: 2006-01
Primary completion: 2007-07
Completion: 2007-08

Publications

Park BH, Hwang T, Liu TC, Sze DY, Kim JS, Kwon HC, Oh SY, Han SY, Yoon JH, Hong SH, Moon A, Speth K, Park C, Ahn YJ, Daneshmand M, Rhee BG, Pinedo HM, Bell JC, Kirn DH. Use of a targeted oncolytic poxvirus, JX-594, in patients with refractory primary or metastatic liver cancer: a phase I trial. Lancet Oncol. 2008 Jun;9(6):533-42. doi: 10.1016/S1470-2045(08)70107-4. Epub 2008 May 19.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pexastimogene Devacirepvec	Other / unclassified	1e+08 unknown	Other
Subject	Pexastimogene Devacirepvec	Other / unclassified	3e+08 unknown	Other
Subject	Pexastimogene Devacirepvec	Other / unclassified	1e+09 unknown	Other
Subject	Pexastimogene Devacirepvec	Other / unclassified	3e+09 unknown	Other

A Study of Recombinant Vaccinia Virus to Evaluate the Safety and Efficacy of a Transdermal Injection Within the Tumor of Patients With Primary or Metastatic Hepatic Carcinoma

Summary

Timeline

Publications

Drugs

Indications