A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors

September 9, 2026 updated by: Guangzhou Virotech Pharmaceutical Co., Ltd.

A Phase I, Open-label, Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Anti-tumor Effects of M1-c6v1 for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

A Phase I Study of the Safety and Tolerability of M1-c6v1 Administered Via Intravenously for Treatment of Patients With Locally Advanced or Metastatic Solid Tumors

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is an open-label, dose-escalation clinical study which aims to evaluate the safety and tolerability of multiple IV injections of M1-c6v1 in subjects with locally advanced/metastatic solid tumors, as well as evaluating the biological distribution characteristics and biological effects of M1-c6v1 (i.e., virus tissue distribution and shedding characteristics), evaluating immunogenicity of M1-c6v1, and preliminarily exploring the anti-tumor effects of M1-c6v1.

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan
        • Recruiting
        • National Cancer Center Hospital East
        • Contact:
    • Ehime
      • Matsuyama, Ehime, Japan
        • Recruiting
        • National Hospital Organization Shikoku Cancer Center
        • Contact:
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subjects must have diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
  2. 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.
  3. Males and females at least 18 years of age, inclusive, at the Screening Visit.
  4. Have at least one measurable lesion.
  5. An Eastern Cooperative Oncology Group (ECOG) score of 0-1, 1 week before the first administration of IMP.
  6. An estimated survival time of ≥ 12 weeks.

Exclusion Criteria:

  1. 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.
  2. Subject has received any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
  3. Subject has received systemic glucocorticoids (prednisone >10 mg/day or equivalent doses of similar drugs) or other immunosuppressive agents within 14 days prior to first administration of IMP.
  4. Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: M1-c6v1 intravenous injection
M1-c6v1 will be administered through IV drip
Biological: M1-c6v1
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 intravenous M1-c6v1 in Patients with advanced malignant tumors
Time Frame: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
About 2 years
Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.
Time Frame: About 2 years
Incidence of DLT
About 2 years
Conduct a dose extension study to evaluate the safety and tolerability of intravenous administration of M1-c6v1 at maximum tolerated dose (MTD) or recommended phase 2 dose (RP2D) levels.
Time Frame: About 2 years
Monitor the incidence of adverse events (TEAEs) during the study.
About 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.
Time Frame: About 2 years
Measure the distribution and shedding of M1-c6v1 following intravenous injection by detecting its presence in blood, saliva, urine, nasal swabs, and feces using qPCR (quantitative polymerase chain reaction) method.
About 2 years
Assess the immunogenicity of intravenous administration of M1-c6v1.
Time Frame: About 2 years
Detect the presence of neutralizing antibodies against M1-c6v1 and assess their titers, which represent the potency of the neutralizing antibodies, using the PD50 value.
About 2 years
Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.
Time Frame: About 2 years
Based on the specific tumor types, assess the ORR (Objective Response Rate) and DCR (Disease Control Rate) using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 or mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria.
About 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Investigators

  • Study Chair: Guangzhou Virotech Pharmaceutical Co., Ltd., Guangzhou Virotech Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 10, 2024

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

December 20, 2028

Study Registration Dates

First Submitted

September 12, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 11, 2026

Last Update Submitted That Met QC Criteria

September 9, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VRT106-J01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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