RecruitingPhase 1NCT05266612

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

Sponsor

Virogin Biotech Canada Ltd

Enrollment

12 participants

Start Date

Nov 9, 2022

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

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

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is testing a new oncolytic virus therapy called VG2025 — alone and in combination with the immunotherapy drug nivolumab — in people with advanced solid tumors that have not responded to standard treatments. The virus is designed to selectively infect and destroy cancer cells while stimulating the immune system. **You may be eligible if...** - You are 18 years or older - You have an advanced solid tumor that has relapsed or not responded to standard treatment, or for which no standard treatment exists - You have at least one injectable tumor lesion (a skin, fat, or lymph node lump that can be directly injected) of at least 15mm - You test positive for herpes simplex virus (HSV) antibodies - You are in generally good physical condition (ECOG 0 or 1) **You may NOT be eligible if...** - You have untreated or active brain metastases - You have received immunotherapy or chemotherapy within recent weeks (specific timeframes apply) - You have active autoimmune disease or are on immunosuppressive therapy - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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