A Study of Intravenous VRT106 for Locally Advanced or Metastatic Solid Tumors

An Open-labeled Phase I Clinical Trial Evaluating the Safety, Tolerability, Biodistribution Characteristics, Biological EEffects, and Initial Efficacy of VRT106 for Injection in the Treatment of Locally Advanced/Metastatic Solid Tumors by Intravenous Administration

A Phase I Study of the Safety and Tolerability of VRT106 Administered Intravenously for Treatment of Patients With Locally Advanced or MetastaticSolid Tumors

Study Overview

• Status: Recruiting
• Conditions: Solid Tumors
• Intervention / Treatment: Biological: VRT106

Detailed Description

To evaluate VRT106 for injection in patients with locally advanced/metastatic solid tumours for safety and tolerability, exploring the maximum tolerated dose (MTD)/maximum administered dose (MAD)/optimal bioavailable dose (OBD) and/or the recommended phase II clinical dose (RP2D) to provide a recommended dose for subsequent clinical trials.

• Study Type: Interventional
• Enrollment (Estimated): 12
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Third Affiliated Hospital, Sun Yat-sen University; Phone Number: +86-020-32030745; Email: clinicaltrialinfo@virot.cn

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • The Third Affiliated Hospital of Sun Yat-Sen University
      • Contact: Liang Peng Principal Investigator, Ph.D; Professor; Phone Number: +86-13556065609; Email: pliang@mail.sysu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Subjects voluntarily participate in the clinical study; fully understand and be informed about the study and sign the ICF; and are willing to follow and have the ability to complete all trial procedures.
2. Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
3. Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
4. Subjects have at least one measurable lesion.
5. ECOG score of 0 to 28 days prior to first dose of IMP.
6. An expected survival time of ≥ 12 weeks.
7. Have sufficient organ function.
8. Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.
9. Subjects of childbearing potential (males and females) agree to use effective birth control with their partner from signing informed consent to at least 90 days after the last dose.

Exclusion Criteria:

1. Subject has received any antitumor therapy within 4 weeks prior to the first dose of IMP.
2. Subject has previously received oncolytic virus or other gene drug therapy.
3. Subject has received treatment with other unlisted clinical investigational drugs/devices within 4 weeks prior to the first dose of IMP.
4. Subject is known to have an allergic reaction to any of the components of IMP.
5. Women who are breastfeeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VRT106 for injection; VRT106 will be administered through IV drip	Biological: VRT106; Intravenous drip administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the safety and tolerability of escalating doses of VRT106 in Patients with advanced malignanttumors	To evaluate the safety and tolerability of VRT106 in patients with locally advanced/metastatic solid tumours and to explore the maximum tolerated dose (MTD)/multiple ascending dose (MAD)/optimal biologically active dose (OBD) and/or the recommended phase 2 dose (RP2D), which will provide a recommended dose for subsequent clinical trials.	About 2 years

Collaborators and Investigators

• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.
• Collaborators: Third Affiliated Hospital, Sun Yat-Sen University

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 13, 2025

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Solid Tumor; Oncolytic Virus; VRT106
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: VRT106-CN01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No