AzTrials
AzTrials

Solid TumorPhase 1NCT05266612

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 testing VG2025 and Nivolumab Injection [Opdivo] in people with Solid Tumor, run by Virogin Biotech Canada Ltd at 2 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Solid Tumor
What is being tested?
VG2025 and Nivolumab Injection [Opdivo]
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
2 sitesUnited States
Study dates
9 Nov 2022to 31 Dec 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Signed written informed consent.
  • Males or females aged ≥ 18 years.
  • Performance status: Eastern Cooperative Oncology Group (ECOG) 0 or 1.
  • Subject with advanced malignant solid tumors which is refractory/relapsed after and/or intolerant of standard therapies or for which no standard therapy exists or available (refer to National Comprehensive Cancer Network [NCCN] guideline).
  • At least 1 injectable cutaneous or subcutaneous lesion ≥15 mm in longest diameter and/or nodal lesions that are visible or palpable deemed injectable.
  • Seropositive for Herpes Simplex Virus (HSV).
Show all 22Show fewer
  • Had an interval of ≥4 weeks (28 days) since exposure to immunotherapy, an interval of ≥3 weeks (21 days) since exposure to systemic chemotherapy, an interval of ≥6 weeks (42 days) since exposure to nitrosourea, and an interval of ≥4 weeks (28 days) since exposure to radiotherapy, prior to dosing.
  • Life expectancy of at least 3 months.
  • Eligibility requirements also include:
  • Hemoglobin ≥ 90 grams (g)/liter (L),
  • ANC ≥1.5 × 10^9/L,
  • Subjects with dermatoses without active infection will be allowed.*
  • Subjects whose baseline pulse oximetry is at least 90% on Room air.
  • Male subjects must abstain from heterosexual activities or agree to use a condom during the study and for 6 months following the end of study. Women of childbearing potential must be willing to abstain from heterosexual activities or agree to use highly effective, double-barrier contraception during the study and for 6 months following the end of study, to avoid pregnancy. Double-barrier contraception is defined as a condom AND one other form of the following:
  • Birth control pills (The Pill)
  • Depo or injectable birth control
  • Intrauterine Device
  • Birth control patch (e.g., Ortho Evra)
  • NuvaRing®
  • Documented evidence of surgical sterilization at least 6 months prior to the Screening visit, i.e., tubal ligation or hysterectomy for women or vasectomy for men.
  • Males must not donate sperm during the study and for at least 6 months after end of the study. Male partners of female subjects and female partners of male subjects must also use contraception, if they are of childbearing potential.
  • Females of childbearing potential must have a negative pregnancy test at Screening and on Day 1.

Who cannot join

  • 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.
  • Tumors to be injected lying in mucosal regions or close to an airway, major blood vessel or spinal cord that, in the opinion of the Investigator could cause occlusion or compression in the case of tumor swelling or erosion into a major vessel in the case of necrosis.
  • Subjects with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including carcinomatosis meningitis are excluded. Subjects with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (magnetic resonance imaging [MRI] or computed tomography [CT] scan) during the screening period and off systemic steroids (for at least 2 weeks prior to first dose of VG2025).
  • Major surgery within 14 days prior to Screening commencement.
  • Intercurrent serious infections within 28 days prior to Screening or treated systematically with intravenous antibiotics within 14 days prior to Screening.
  • Life-threatening illness unrelated to cancer.
Show all 17Show fewer
  • Active Herpes or COVID-19 infections
  • Treatment with antiviral agents within 14 days prior to Screening commencement.
  • Subjects with congestive heart failure (as defined by New York Heart Association Functional Classification III or IV), unstable angina, serious uncontrolled cardiac arrhythmia, a myocardial infarction within 6 months prior to study entry or a history of myocarditis.
  • Known to test positive for human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (>10 milligrams (mg) daily prednisone equivalent) or other immunosuppressive medications within 14 days prior to dosing. Inhaled or topical steroids, and adrenal replacement steroid doses, are permitted in the absence of active autoimmune disease.
  • Subjects who have been on systemic anticoagulants and cannot safely hold anticoagulation for planned intratumoral injections and study procedures.
  • Subjects with prior radiation therapy to the tumor lesion to be injected are excluded from the study, unless there is evidence of tumor progression in the most recent imaging or by biopsy, following completion of radiotherapy.
  • Subjects with active or documented history of autoimmune disease within 2 years prior to Screening commencement.
  • Please note that subjects with vitiligo, resolved childhood asthma/atopy, autoimmune endocrinopathy on stable replacement therapy, or psoriasis not requiring systemic treatment within the past 2 years will be allowed.
  • Subjects with history of primary immune deficiency.
  • Subjects with history of organ transplant that requires use of immunosuppressive medications.

Trial locations and contacts

2 sites in 1 country.

Naghmeh Esmaeili contact

7785589840

nesmaeili@virogin.com

Mike Teng contact

miketeng@virogin.com

United States2 sites, 2 recruiting

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

    Madappa Kundranda, MD, 480-256-3311, Madappa.Kundranda@bannerhealth.com

    Recruiting

  • MD Anderson

    Houston, Texas, 77030

    Siqing Fu, siqingfu@mdanderson.org

    Recruiting

Other trials in United States

About this study

Official title: 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

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
Solid Tumor
Being tested
VG2025, Nivolumab Injection [Opdivo]
Keywords
Neuroendocrine Tumors
Medical subject headings
Neuroendocrine Tumors

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VG2025Drug

    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 groups in NCT05266612
Study groupRoleWhat they receive
Monotherapy ArmExperimentalThis 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.
Receives: Drug: VG2025
Combination ArmExperimentalThe 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
Receives: Drug: VG2025; Drug: Nivolumab Injection [Opdivo]

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events

    Incidence of Adverse Events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0

    Measured: 12 months

  2. MTD

    Recommended Phase 2 Dose

    Measured: 12 months

Secondary outcomes (8)

  1. Level of deoxyribonucleic acid (DNA)

    shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)

    Measured: 12 months

  2. interleukin level

    evaluate the interleukin (IL)-12 and IL-15 in injected tumor (biopsy samples) and blood

    Measured: 12 months

  3. ADA level of VG2025

    evaluate anti-drug antibody [ADA]

    Measured: 12 months

  4. Nab level of VG2025

    evaluate neutralizing antibody [Nab]

    Measured: 12 months

  5. ORR

    Objective response rate (ORR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

    Measured: 12 months

  6. DoR

    Duration of response (DoR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

    Measured: 12 months

  7. DCR

    Disease control rate (DCR) based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

    Measured: 12 months

  8. PFS

    Progression-free survival (PFS), based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and RECIST

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2022
  2. Study start9 Nov 2022
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05266612
Sponsor's protocol ID
VG201-A101
Status last verified
Aug 2024
First submitted
9 Feb 2022
Last updated
9 Aug 2024
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing VG2025 and Nivolumab Injection [Opdivo] in people with Solid Tumor, run by Virogin Biotech Canada Ltd at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Naghmeh Esmaeili (7785589840, nesmaeili@virogin.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05266612.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in