A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors

NCT06368921 | Recruiting Phase 1

• 1 other identifier: VRT106-C01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (2)

• Evaluate the safety and tolerability of escalating doses of intratumoral injection of VRT106.

  Incidence rate of TEAE

  About 2 years

• Characterize the maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.

  Incidence rate of DLT

  About 2 years

Secondary Outcomes (4)

• Examine the biological distribution characteristics and shedding patterns of intratumoral injection of VRT106.

  About 2 years

• Assess the immunogenicity of intratumoral injection of VRT106.

  About 2 years

• Assess the anti-tumor effect of VRT106, including objective response rate (ORR) as efficacy indicators.

  About 2 years

• Assess the anti-tumor effect of VRT106, including disease control rate (DCR) as efficacy indicators.

  About 2 years

Study Arms (1)

VRT106

EXPERIMENTAL

VRT106

Biological: VRT106

Interventions

VRT106 BIOLOGICAL

intratumoral injection

VRT106

Eligibility Criteria

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

You may qualify if:

• Subject voluntarily agrees to participate in this study and signs an Institutional Review Board -approved informed consent prior to performing any of the Screening Visit procedures.
• Males and females at 18-75 years of age, inclusive, at the Screening Visit.
• Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
• Have at least one injectable lesion.
• An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• An estimated survival time of ≥ 12 weeks.

You may not qualify if:

• Subject has received any anti-tumor treatment 4 weeks before using the IMP.
• Subject has received any prior oncolytic viruses or other gene therapies.
• Subject has a history of primary or acquired immunodeficient states, leukemia, lymphoma, acquired immunodeficiency syndrome (AIDS) or other clinical manifestations of infection with human immunodeficiency viruses, and those on immunosuppressive therapy.
• Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

Sponsors & Collaborators

• Guangzhou Virotech Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

RECRUITING

Affiliated Cancer Hospital of Zhengzhou University

Zhengzhou, Henan, China

RECRUITING

Affiliated Cancer Hospital of Shandong First Medical University

Jinan, Shandong, China

RECRUITING

Central Study Contacts

Hongyun Zhao

CONTACT

020-87343565; zhaohy@syscc.org.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: April 9, 2024
• First Posted: April 16, 2024
• Study Start: June 19, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)