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Phase 1 Study of GEN2 in Patients With Advanced Solid Tumors

NCT06391918 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-03-13

No results posted yet for this 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.

Conditions

  • Solid Tumor, Adult

Interventions

BIOLOGICAL

GEN2 + Valganciclovir

Gene therapy vector product

Sponsors & Collaborators

  • GenVivo, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-04
Primary Completion
2026-03-01
Completion
2026-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06391918 on ClinicalTrials.gov