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 (May 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
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 →
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