GEN2 Directed Cancer Immunotherapy Trial
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Hepatocellular Carcinoma
- Metastatic Cancer
- Type
- Interventional
- Phase
- Phase 1
- Design
- Allocation: Non-RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Dose Escalation TrialMasking: None (Open Label)Primary Purpose: Other
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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 o...
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.
Tracking Information
- NCT #
- NCT04313868
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Priscilla B Caguioa, MD St. Luke's Medical Center - Quezon City Principal Investigator: Maria Belen E Tamayo, MD Makati Medical Center Principal Investigator: John P Querol, MD The Medical City Principal Investigator: Necy S Juat, MD National Kidney and Transplant Institute Principal Investigator: Gracieux Y Fernando, MD Manila Doctors Hospital