OncoMatch/Clinical Trials/NCT05266612
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors
Is NCT05266612 recruiting? Yes, currently enrolling (Jun 2026). This Phase 1 trial studies multiple treatments including VG2025 and Nivolumab for solid tumor.
Treatment: VG2025 · Nivolumab — 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
Check if I qualifyExtracted eligibility criteria
Treatments studied
Immunotherapy
Other
Cancer type
Tumor Agnostic
Disease stage
Metastatic disease required
advanced malignant solid tumors which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists or available
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard therapies
refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists or available
Cannot have received: immunotherapy
Exception: if half-life is more than 5 days within the last 4 weeks prior to dosing
Participation in any previous immunotherapy trial or any trial of any other investigational agent if half-life is more than 5 days within the last 4 weeks prior to dosing
Cannot have received: antiviral agents
Treatment with antiviral agents within 14 days prior to Screening commencement
Cannot have received: systemic chemotherapy
Exception: interval of ≥3 weeks (21 days) since exposure to systemic chemotherapy, prior to dosing
an interval of ≥3 weeks (21 days) since exposure to systemic chemotherapy, prior to dosing
Cannot have received: nitrosourea
Exception: interval of ≥6 weeks (42 days) since exposure to nitrosourea, prior to dosing
an interval of ≥6 weeks (42 days) since exposure to nitrosourea, prior to dosing
Cannot have received: radiotherapy
Exception: interval of ≥4 weeks (28 days) since exposure to radiotherapy, prior to dosing
an interval of ≥4 weeks (28 days) since exposure to radiotherapy, prior to dosing
Lab requirements
Blood counts
hemoglobin ≥ 90 grams (g)/liter (l), anc ≥1.5 × 10^9/l
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- MD Anderson · Houston, Texas
Showing up to 5 US sites.
See all sites on ClinicalTrials.gov →Frequently asked questions
Is NCT05266612 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior immunotherapy, antiviral agents, systemic chemotherapy disqualifies patients from enrollment.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualify