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

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Virogin Biotech Canada Ltd
Study ID
NCT05266612
Phase
PHASE1
Status
Recruiting
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Conditions

  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • VG2025 — DRUG
    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
  • Nivolumab Injection [Opdivo] — DRUG
    Flat dose of 240 mg every two weeks.

Study Details

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

Key Dates

Start date
Nov 9, 2022
Status verified
Aug 2024
Primary completion
Dec 31, 2024
Completion
Dec 31, 2025

Study Design

Enrollment
12 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monotherapy Arm
    This is an open label trial using standard 3+3 design, in up to 24 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients.
  • Experimental: Combination Arm
    The starting dose of VG2025 in the combination cohorts will be a dose of 1.0 x108 PFU for combination cohort 1 on days 1 and 15 of every cycle. Combination cohort 2 will be dosed at 1.0 x108 PFU on Day 1 and either Day 2 or 3 in cycle 1 and 2. Day 1 only in subsequent cycles

Primary Outcome Measure

Incidence of Adverse Events [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Banner MD Anderson Cancer CenterGilbertArizona85234
Madappa Kundranda, MD
[email protected]
480-256-3311
MD AndersonHoustonTexas77030

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By research site
Banner MD Anderson Cancer Center· Gilbert, AZMD Anderson· Houston, TX

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