Intrahepatic Cholangiocarcinoma
Conditions
Brief summary
VG2025 is a Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection. Currently, one phase I dose escalation safety study has been completed in China and the United States respectively, both demonstrating excellent safety profiles with no dose-limiting toxicities (DLTs) observed and no maximum tolerated dose (MTD) identified. Moreover, it has shown preliminary efficacy in treating advanced tumors. Considering the actual clinical needs and the volume of intratumoral administration, a more appropriate recommended phase 2 dose (RP2D) level has been selected for the phase II clinical trial.
Interventions
DRUGVG2025
Recommended Phase II Dose, Intratumoral Injection, Q4W
Sponsors
Virogin Biotech 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. Histologically or cytologically confirmed advanced intrahepatic cholangiocarcinoma. 4. Eligible participants of childbearing participants(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. Participants who have received other unlisted drugs clinical trial treatment 4 weeks before the first dose of the study drug. 2. Participants 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. Participants with mental disorders or poor compliance. 7. Women who are pregnant or breastfeeding. 8. Participants 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 |
|---|---|---|
| ORR | up to 36 months | Objective response rate (ORR) |
| DCR | up to 36 months | Disease control rate (DCR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS | up to 36 months | Progression-free survival (PFS) |
| OS | up to 36 months | Overall Survival (OS) |
| Correlation between VG2025 efficacy and CEA levels | up to 36 months | Preliminary analysis of the correlation between the efficacy of VG2025 and peripheral blood carcinoembryonic antigen (CEA) levels |
| Immune-related indicators | up to 36 months | Peripheral blood lymphocyte subsets, plasma cytokines, T cell immunity, and other immune-related indicators |
| Adverse Events (AEs) and Serious Adverse Events (SAEs) | up to 36 months | Safety will be evaluated according to CTCAE 6.0, including AEs/SAEs during the study, abnormalities or changes in 12-lead ECGs, and laboratory tests. |
Countries
China
Contacts
CONTACTYinan Shen
PRINCIPAL_INVESTIGATORTingbo Liang, M.D.，PhD
Zhejiang University
Outcome results
None listed