NCT05266612

Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors

A Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Virogin Biotech Canada Ltd · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. All patients within a given dose level cohort will be treated with the same dose schedule of VG2025, administered as intratumoral injections at Day 1 and Day 15 biweekly at each treatment cycle (monotherapy cohorts 1-4 and combination cohort 1) and on day 1 and either day 2 or day 3 at the first 2 cycles followed by day 1 only at subsequent cycles (combination cohort 2). Dose limiting toxicity (DLT) evaluation period is for 4 weeks, from the start of treatment, Day 1, through Day 28. There are two parts to this study a monotherapy arm and a combination therapy arm. In the monotherapy arm the patients will receive VG2025 only. In the combination therapy arm the patients will receive VG2025 and Nivolumab

Conditions

• Solid Tumor

Interventions

Type	Name	Description
DRUG	VG2025	1. 1.0×108PFU Day 1 and 15 2. 2.0×108PFU Day 1 and 15 3. 3.0×108PFU Day 1 and 15 4. 4.0×108PFU Day 1 and 15
DRUG	Nivolumab Injection [Opdivo]	Flat dose of 240 mg every two weeks.

Timeline

• Start date: 2022-11-09
• Primary completion: 2024-12-31
• Completion: 2025-12-31
• First posted: 2022-03-04
• Last updated: 2024-08-09

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study