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

NCT ID: NCT06826313

Last Updated: 2025-07-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-03-19
• Study Completion Date: 2027-03-01

Brief Summary

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

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.

Conditions

Solid Tumors

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VRT106 for injection

VRT106 will be administered through IV drip

Group Type: EXPERIMENTAL

VRT106

Intervention Type: BIOLOGICAL

Intravenous drip administration

Interventions

VRT106

Intravenous drip administration

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role: collaborator

Guangzhou Virotech Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Third Affiliated Hospital, Sun Yat-sen University

Role: CONTACT

clinicaltrialinfo@virot.cn

+86-020-32030745

Facility Contacts

Liang Peng Principal Investigator, Ph.D; Professor

Role: primary

pliang@mail.sysu.edu.cn

+86-13556065609

Other Identifiers

VRT106-CN01

Identifier Type: -

Identifier Source: org_study_id