A Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in Patients With Solid Tumors

Advanced Malignant Solid Tumor Clinical Trial

Official title:

A Dose Escalation, Open-label Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Biologic Effect of VG2025 in the Treatment of Patients With Advanced Malignant Solid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05477849
• Other study ID #: VG201-C101
• Status: Recruiting
• Phase: Phase 1
• Start date: August 23, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: October 2022
• Source: Virogin Biotech Ltd.
• Contact: Yinan Shen
• Phone: +86-0571-87236666
• Email: fysyn[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Advanced Malignant Solid Tumor
• Neoplasms

Intervention

Drug:
• Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection
Dose level 1 Dose level 2 Dose level 3 Dose level 4 Dose level 5

Locations

Country	Name	City	State
China	The First Affiliated Hospital,Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Virogin Biotech Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MTD/RP2D	Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)	During the 28 day DLT observation period
Primary	Adverse Events (AEs) and Serious Adverse Events (SAEs)	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	12 months
Secondary	Level of deoxyribonucleic acid (DNA)	Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)	12 months
Secondary	Interleukin level	Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels	12 months
Secondary	ORR	Objective response rate (ORR)	Multiple time points before and after administration
Secondary	DCR	Disease control rate (DCR)	12 months
Secondary	PFS	Progression-free survival (PFS)	12 months
Secondary	OS	Overall Survival (OS)	12 months
Secondary	Antibodies	VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab)	12 months