Actively Recruiting
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors
Led by Virogin Biotech Canada Ltd · Updated on 2024-08-09
12
Participants Needed
2
Research Sites
164 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Phase I Study VG2025 as a Single Agent and in Combination Therapy With Nivolumab in Subjects With Advanced Malignant Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed written informed consent.
- Male or female aged 18 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Advanced malignant solid tumors refractory, relapsed after, or intolerant of standard therapies, or no standard therapy available.
- At least one injectable cutaneous or subcutaneous lesion measuring 15 mm or more in longest diameter, or nodal lesions that are visible or palpable and injectable.
- Seropositive for Herpes Simplex Virus (HSV).
- At least 4 weeks since last immunotherapy, 3 weeks since last systemic chemotherapy, 6 weeks since nitrosourea, and 4 weeks since radiotherapy before dosing.
- Life expectancy of at least 3 months.
- Hemoglobin level of at least 90 g/L.
- Absolute neutrophil count (ANC) of at least 1.5 x 10^9/L.
- Dermatoses allowed if no active infection.
- Baseline pulse oximetry of at least 90% on room air.
- Males must abstain from heterosexual activity or use condoms during and for 6 months after the study; females of childbearing potential must use highly effective double-barrier contraception or abstain during and for 6 months after the study.
- Males must not donate sperm during and for 6 months after the study; partners of participants must also use contraception if of childbearing potential.
- Females of childbearing potential must have negative pregnancy tests at screening and on Day 1.
You will not qualify if you...
- Participation in any immunotherapy trial or investigational agent trial with half-life over 5 days within 4 weeks prior to dosing.
- Tumors located in mucosal regions or near airway, major blood vessels, or spinal cord that could risk occlusion or compression if swelling occurs.
- Primary central nervous system malignancy including glioma, active or progressing CNS malignancy, or carcinomatosis meningitis; treated brain metastases allowed if stable for at least 4 weeks off systemic steroids.
- Major surgery within 14 days before screening.
- Serious infections within 28 days before screening or intravenous antibiotics within 14 days before screening.
- Life-threatening illnesses unrelated to cancer.
- Active Herpes or COVID-19 infections.
- Antiviral treatment within 14 days before screening.
- Congestive heart failure (NYHA class III or IV), unstable angina, serious uncontrolled arrhythmia, recent myocardial infarction within 6 months, or history of myocarditis.
- Positive tests for HIV, hepatitis B or C, or syphilis.
- Need for systemic corticosteroids over 10 mg prednisone or other immunosuppressants within 14 days before dosing, except inhaled/topical steroids without active autoimmune disease.
- Use of systemic anticoagulants that cannot be safely paused for injections and procedures.
- Prior radiation therapy to the tumor to be injected unless progression is documented.
- Active or history of autoimmune disease within 2 years, except stable conditions like vitiligo, resolved childhood asthma/atopy, autoimmune endocrinopathy on stable therapy, or psoriasis not requiring systemic treatment.
- History of primary immune deficiency.
- History of organ transplant requiring immunosuppressive drugs.
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
Actively Recruiting
2
MD Anderson
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
N
Naghmeh Esmaeili
CONTACT
M
Mike Teng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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