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

• Sponsor: Shanghai Virogin Biotech Co., Ltd. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05477849
• Collaborator: (none)
• Enrollment: 30
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 29.1
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignant Solid Tumor	Drug: Recombinant Human IL12/15 Dual-Regulated Oncolytic HSV-1 Injection	Phase 1

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 30 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Jul 30, 2022
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 3+3 design This is an open label, single-arm trial using standard 3+3 design, in up to 30 HSV seropositive subjects. This rule-based design proceeds with cohorts of three patients	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; Other Names: VG2025

Outcome Measures

Primary Outcome Measures

1. MTD/RP2D [During the 28 day DLT observation period]

   Maximum tolerable dose (MTD) / Recommended dose for phase II (RP2D)

2. 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 Outcome Measures

1. Level of deoxyribonucleic acid (DNA) [12 months]

   Shedding profile of detectable VG2025 deoxyribonucleic acid (DNA)

2. Interleukin level [12 months]

   Evaluate the interleukin-12 (IL-12) and interleukin-12 (IL-15) levels

3. ORR [Multiple time points before and after administration]

   Objective response rate (ORR)

4. DCR [12 months]

   Disease control rate (DCR)

5. PFS [12 months]

   Progression-free survival (PFS)

6. OS [12 months]

   Overall Survival (OS)

7. Antibodies [12 months]

   VG2025 anti-drug antibodies (ADA) and neutralizing antibody (Nab)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The First Affiliated Hospital，Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310003

Sponsors and Collaborators

• Shanghai Virogin Biotech Co., Ltd.

Investigators

• Principal Investigator: Tingbo Liang, M.D.，PhD, The First Affiliated Hospital, Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Shanghai Virogin Biotech Co., Ltd.
• ClinicalTrials.gov Identifier: NCT05477849
• Other Study ID Numbers: VG201-C101
• First Posted: Jul 28, 2022
• Last Update Posted: Jul 28, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasms

Study Results

No Results Posted as of Jul 28, 2022