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

NCT06826313 | Recruiting Phase 1 DMC

• 1 other identifier: VRT106-CN01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Solid Tumors

Keywords

Solid Tumor; Oncolytic Virus; VRT106

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

VRT106 for injection

EXPERIMENTAL

VRT106 will be administered through IV drip

Biological: VRT106

Interventions

VRT106 BIOLOGICAL

Intravenous drip administration

VRT106 for injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Males and females are aged at 18-75 years (including borderline values) at the time of signing the ICF, male or female.
• Subjects are histologically or cytologically confirmed to be intolerable or refractory to the standard systemic treatment.
• Subjects have at least one measurable lesion.
• ECOG score of 0 to 28 days prior to first dose of IMP.
• An expected survival time of ≥ 12 weeks.
• Have sufficient organ function.
• Female patients of childbearing potential with a negative serum pregnancy test within 7 days prior to first dose of study drug.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

RECRUITING

Central Study Contacts

Third Affiliated Hospital, Sun Yat-sen University

CONTACT

+86-020-32030745; clinicaltrialinfo@virot.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 13, 2025
• Study Start: March 19, 2025
• Primary Completion: December 30, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 18, 2025

Record last verified: 2025-03

Locations

CN (1)