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New treatment option for Solid Tumor
Official title Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors
ClinicalTrials.gov ID: NCT05266612
What this study is testing
What is VG2025?
VG2025 is an investigational medicine, given as an once-weekly injectable medicine, being studied as a potential treatment for solid tumor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- At least 1 injectable cutaneous or subcutaneous lesion ≥15 mm in longest diameter and/or nodal lesions that are visible or palpable deemed injectable.
You likely can't join if
- 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...
- 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...
- people with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including...
- 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...
- Life-threatening illness unrelated to cancer.
See the full eligibility criteria
- 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...
- 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).
- 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...
- Life expectancy of at least 3 months.
- Eligibility requirements also include:
- Hemoglobin ≥ 90 grams (g)/liter (L),
- ANC ≥1.5 × 10\^9/L,
- people with dermatoses without active infection will be allowed.\
- people whose baseline pulse oximetry is at least 90% on Room air.
- Male people 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...
- 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 people and female partners of male people must also use contraception, if they are of childbearing...
- Females of childbearing potential must have a negative pregnancy test at Screening and on Day 1.
- 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...
- people with any primary Central Nervous System (CNS) malignancy including glioma and current, active, progressing CNS malignancy, including carcinomatosis meningitis are excluded. people with treated brain metastases...
- 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.
- Active Herpes or COVID-19 infections
- Treatment with antiviral agents within 14 days prior to Screening commencement.
- people 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...
- Known to test positive for human immunodeficiency virus (HIV), hepatitis B or C virus, or syphilis.
- people 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...
- people who have been on systemic anticoagulants and cannot safely hold anticoagulation for planned intratumoral injections and study procedures.
- people 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...
- people with active or documented history of autoimmune disease within 2 years prior to Screening commencement. Please note that people with vitiligo, resolved childhood asthma/atopy, autoimmune endocrinopathy on stable...
- people with history of primary immune deficiency.
- people with history of organ transplant that requires use of immunosuppressive medications.
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.