Advanced Malignant Solid Tumor
Conditions
Brief summary
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. This Phase I study will be conducted in herpes simplex virus (HSV) -seropositive subjects with advanced malignant solid tumors that are refractory to conventional therapies. This is an open label study to determine the safety and tolerability of VG2025, and recommended dose of VG2025 for Phase II trials.
Detailed description
This is a Phase 1, open-label, dose-escalation trial using standard 3+3 dose-escalation design in patients with advanced malignant solid tumors. The trial will be conducted in multiple dosing cohorts, and evaluated for safety to determine the Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D). Dose limiting toxicity (DLT) evaluation period is for 4 weeks from the start of treatment Day 1 through Day 28.
Interventions
1. Dose level 1 2. Dose level 2 3. Dose level 3 4. Dose level 4 5. Dose level 5
Sponsors
Shanghai Virogin Biotech Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent form. 2. Age 18 to 75 years (inclusive), male or female. 3. Subject with advanced malignant solid tumors who have failed standard treatment and for whom there is no effective treatment at this stage. 4. Eligible patients of childbearing potential (male and female) must agree to use a reliable method of contraception during the trial and for at least 90 days after dosing; females of childbearing potential must have a negative blood pregnancy test 7 days before enrollment.
Exclusion criteria
1. Subjects who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug. 2. Subjects who underwent major organ surgery (excluding needle biopsy) or had significant trauma 4 weeks before the first dose of the study drug. 3. In the herpes simplex virus recurrence and infection period, and there are corresponding clinical manifestations, such as oral herpes labialis, herpetic keratitis, herpetic dermatitis, genital herpes and so on. 4. Other active uncontrolled infection. 5. Known alcohol or drug dependence. 6. Subjects with mental disorders or poor compliance. 7. Women who are pregnant or breastfeeding. 8. Subjects in the opinion of the investigator are not suitable for this clinical study due to other serious systemic diseases or other reasons.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MTD/RP2D | During the 28 day DLT observation period | Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D) |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | 12 months | Occurence of Adverse Events (AEs) and Serious Adverse Events (SAEs)as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | Multiple time points before and after administration | Objective response rate (ORR) |
| DCR | 12 months | Disease control rate (DCR) |
| Level of deoxyribonucleic acid (DNA) | 12 months | Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA) |
| OS | 12 months | Overall Survival (OS) |
| Antibodies | 12 months | VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab) |
| PFS | 12 months | Progression-free survival (PFS) |
| Interleukin level | 12 months | Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels |
Countries
China
Contacts
Primary ContactYinan Shen
Outcome results
None listed