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

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: Solid Tumor
• Intervention / Treatment: Biological: M1-c6v1

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

• Study Contact: Name: Guangzhou Virotech Pharmaceutical Co., Ltd.; Phone Number: +86-020-32030725; Email: clinicaltrialinfo@virot.cn

Study Locations

• Japan
  • Chiba
    • Kashiwa-shi, Chiba, Japan
      • Recruiting
      • National Cancer Center Hospital East
      • Contact: Dr. Kojima Takashi, M.D.; Phone Number: +81-4-7133-1111; Email: clinicaltrialinfo@virot.cn
  • Ehime
    • Matsuyama-shi, Ehime, Japan
      • Recruiting
      • National Hospital Organization Shikoku Cancer Center
      • Contact: Dr. Nishina Tomohiro, M.D.; Phone Number: +81-89-999-1111; Email: clinicaltrialinfo@virot.cn
  • Kanagawa
    • Kawasaki-shi, Kanagawa, Japan
      • Recruiting
      • St. Marianna University Hospital
      • Contact: Dr. Sunakawa, Yu, M.D.; Email: clinicaltrialinfo@virot.cn

Participation Criteria

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

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: 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	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.	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.	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.	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.	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.	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

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

Study record dates

Study Major Dates

• Study Start (Estimated): May 10, 2024
• Primary Completion (Estimated): August 10, 2025
• Study Completion (Estimated): December 20, 2026

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 (Estimated): May 15, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Solid Tumor; Oncolytic Virus; M1-c6v1; VRT106
• Additional Relevant MeSH Terms: Neoplasms
• 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