Clinical Study of VG161 in Subjects with Advanced Primary Liver Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-16

Study Completion Date

2024-12-31

Brief Summary

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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 primary liver cancer that are refractory to conventional therapies. This is an open label study and it's divided into two parts.

Part 1: This part is ascending dose design to determine the safety and tolerability of VG161 and find recommended dose of VG161.

Part 2: This part is extended dose design to determine the effectiveness of VG161.

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Detailed Description

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Part 1: This part will be conducted in 5 dose ascending cohorts, including 2 accelerated titration design dose group and 3 dose escalation groups. Descriptive statistics will be used to summarize data.

Part 2: This part will only include the part 1 recommended dose. Hypothesis test and descriptive statistics will be used to summarize data.

Conditions

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Primary Liver Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VG161

Part1:

1. 1.0\*10\^8 PFU on Day 1(1.0×10\^8PFU)
2. 1.0\*10\^8 PFU on Days 1 to 2(2.0×10\^8PFU)
3. 1.0\*10\^8 PFU on Days 1 to 3(3.0×10\^8PFU)
4. 1.3\*10\^8 PFU on Days 1 to 3(4.0×10\^8PFU)
5. 1.7\*10\^8 PFU on Days 1 to 3(5.0×10\^8PFU)

Part2:

Depends on the recommended dose in Part1

Group Type EXPERIMENTAL

Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))

Intervention Type DRUG

Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.

Interventions

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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.

Intervention Type DRUG

Other Intervention Names

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VG161

Eligibility Criteria

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Exclusion Criteria

1. Subject in prior anti-tumor therapies such as chemotherapy, radiotherapy, biotherapy, endocrinotherapy, targeted therapy, immunotherapy within 4 weeks of study treatment initiation. Oral fluorouracil analogues and small molecule targeted drugs were 2 weeks prior to the first dose of study drug or within 5 half-lives of the drug (whichever was longer).
2. Transcatheter arterial chemoembolization(TACE) within 4 weeks of study treatment initiation
3. Participation in clinical trials of any other investigational agents within 4 weeks of study treatment initiation.
4. Major organ surgery (excluding puncture biopsy) or significant trauma within 4 weeks of study treatment initiation.
5. Patients who received systemic treatment with either corticosteroids ( \>10 mg/ daily prednisone or equivalent) or other immunosuppressive medications within 14 days of study treatment initiation.
6. Subjects with any ≥Grade 1 toxicity (as per NCI CTC AE Version 5.0) related to prior anti-cancer therapy (except for toxicity that the investigator assessed to be no safety risk, such as alopecia.).
7. Subjects with Central Nervous System (CNS) metastasis or meningeal metastasis .
8. Seronegative for Herpes Simplex Virus (HSV) (HSV-1IgG and HSV-1IgM).
9. Subjects with the relapse of HSV infection and relevant clinical manifestations, such as lip herpes, herpes keratitis, herpes dermatitis, and genital herpes.
10. Subjects with other uncontrolled active infections.
11. Known history of immunodeficiency and test positive of human immunodeficiency virus (HIV).
12. History of severe cardiovascular disease:

1)Ventricular arrhythmias requiring clinical intervention; 2)QTc interval \>480 ms; 3)Acute coronary syndrome, congestive heart failure, stroke or other cardiovascular events of III grade or above within 6 months; 4)The cardiac function grade≥II or left ventricular ejection fraction (LVEF) \<50% per the New York Heart Association (NYA); 5)Uncontrolled hypertension.

13\. Subjects with active or past autoimmune diseases that are likely to recur (e.g. systemic lupus erythematosus, rheumatoid arthritis, vasculitis, etc.); acceptable for patients with clinically stable autoimmune thyroiditis.

14\. Previous immunotherapy with an immune-related adverse event (irAE) such as immune-related pneumonia, myocarditis, etc., which, in the judgement of the investigator, may affect the safety of the investigational drug. 15. known to have alcohol or drug dependence. 16. Persons with mental disorders or poor compliance. 17. Pregnant or lactating women. 18. Subjects with any significant unrelated systemic illness that to the investigator's opinion would compromise the subject's eligibility to participate the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No