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NCT05266612 · ClinicalTrials.gov registry record · Phase 1
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors
A Phase 1 study of Solid Tumor, sponsored by Virogin Biotech Canada.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 2
- Study locations
NCT05266612 is a Phase 1 study of Solid Tumor that is actively recruiting participants, run by Virogin Biotech Canada. The registered enrollment target is 12 participants, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT05266612, a Phase 1 study of Solid Tumor, is actively recruiting participants, sponsored by Virogin Biotech Canada.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 2
- Study locations
Study 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 Studied
Interventions
- DRUG VG2025
- DRUG Nivolumab Injection [Opdivo]
Study Locations (2)
Arizona
- Banner MD Anderson Cancer Center - Gilbert
Texas
- MD Anderson - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2022-11-09 |
| Est. Completion | 2025-12-31 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05266612
The ClinicalTrials.gov registry entry for NCT05266612 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 222-participant average among 196 other Solid Tumor trials with a reported enrollment target (95% lower). The listed sponsor is Virogin Biotech Canada, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Solid Tumor appearing as the primary indexed condition, and to 2 interventions - of which VG2025 is the first listed.
NCT05266612 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Arizona, Texas.
Frequently Asked Questions
What is clinical trial NCT05266612 about?
NCT05266612 is a clinical study titled "Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors". 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 D...
What is the current status of trial NCT05266612?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2022-11-09. Estimated completion is 2025-12-31.
What conditions does trial NCT05266612 study?
This clinical trial studies the following conditions: Solid Tumor.
What interventions are being tested in trial NCT05266612?
The interventions under investigation include: VG2025 (DRUG), Nivolumab Injection [Opdivo] (DRUG).
Who is sponsoring clinical trial NCT05266612?
This trial is sponsored by Virogin Biotech Canada, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05266612 being conducted?
This trial has 2 study locations across Arizona, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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