A Phase 1 Study of GEN2 in Adult Patients With Locally Advanced or Metastatic Solid Tumor Malignancies

Study Summary

Protocol GVO-1102 is a phase 1, open label, multi-center study in adult patients with locally advanced or metastatic solid tumors. This study includes two parts: dose escalation and dose expansion. In the dose escalation phase, GEN2 will be administered at increasing dose levels via intravenous infusion or intratumoral injection on Days 1, 3 and 8 every 4 weeks. Valganciclovir will start dosing on Day 12 and continue for 10 days (through Day 21). Once a recommended dose has been defined in approximately 35-45 patients, the dose expansion phase will initiate to further assess intravenous administration of GEN2 in specific tumor types. Approximately 15 patients per tumor type will be enrolled in the intravenous dose expansion phase.

Interventions

Study Locations

Facility	City	State	Country
City of Hope	Duarte	California	United States
University of Southern California-Keck School of Medicine	Los Angeles	California	United States
UCLA Hematology-Oncology	Los Angeles	California	United States
Indiana University Melvin and Bren Simon Comprehensive Cancer Center	Indianapolis	Indiana	United States
University of Iowa Health Care	Iowa City	Iowa	United States
SCRI Oncology Partners	Nashville	Tennessee	United States
NEXT Oncology	Fairfax	Virginia	United States

Official Trial Information

View on ClinicalTrials.gov