NCT04313868

GEN2 Directed Cancer Immunotherapy Trial

A Phase 1 Dose Escalation Trial to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of GEN2 in Refractory Patients With Primary Hepatocellular Carcinoma or Tumors Metastatic to the Liver

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: GenVivo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Phase 1, non-randomized, open label dose escalation clinical trial evaluating the safety of GEN2 in participants with primary \& metastatic liver tumors.

Detailed description

This clinical trial will be divided into two phases: Phase IA in which the dose, route, and schedule of the GEN2 administration is determined and Phase IB which is designed to explore the activity of GEN2 in patients of a defined or several defined tumor types and stages based on the Phase IA data of GEN2. Phase IA is divided into three routes of administration: (a) Phase 1A.1 which explores peripheral IV infusion; (b) Phase IA.2 which investigates hepatic arterial infusion and (c) Phase IA.3 which examines intratumoral delivery.

Conditions

• Hepatocellular Carcinoma
• Metastatic Cancer

Interventions

Type	Name	Description
DRUG	GEN2 (HSV-Thymidine Kinase-m2 and hGM-CSF Genes)	GEN2 is an investigational drug combining cytotoxic and immunotherapy.

Timeline

• Start date: 2014-06-13
• Primary completion: 2023-12-12
• Completion: 2023-12-12
• First posted: 2020-03-18
• Last updated: 2024-11-06

Locations

4 sites across 1 country: Philippines