Trials / Unknown
UnknownNCT04758897
Clinical Study of VG161 in Subjects With Advanced Malignant Solid Tumors
A Dose Ascending, Open Phase I Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of VG161 in Subjects With Advanced Malignant Solid Tumors
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (estimated)
- Sponsor
- CNBG-Virogin Biotech (Shanghai) Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
VG161 is a recombinant human-IL12/15/PDL1B oncolytic HSV-1 Injectable. This Phase I study will be conducted in 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 VG161, and recommended dose of VG161 for Phase II trials.
Detailed description
The trial will be conducted in 7 dose ascending cohorts, including 3 single dose accelerated titration design pilots and 4 multiple dose escalation groups. Descriptive statistics will be used to summarize all data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell)) | Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5. |
Timeline
- Start date
- 2021-04-14
- Primary completion
- 2022-03-14
- Completion
- 2022-12-01
- First posted
- 2021-02-17
- Last updated
- 2021-04-27
Locations
2 sites across 1 country: China
Source: ClinicalTrials.gov record NCT04758897. Inclusion in this directory is not an endorsement.