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

Phase 1

Recruiting

• Conditions: Solid Tumor
• Interventions: Biological: M1-c6v1

• Registration Number: NCT06046742
• Lead Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd.

Brief Summary

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

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 Timeline

• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-19
• Study First Posted: 2023-09-21
• Study Start: 2024-07-10
• Status Verified: 2024-12
• Last Update Submitted: 2025-03-10
• Last Update Posted: 2025-03-13
• Primary Completion: 2026-06-30
• Study Completion: 2026-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
M1-c6v1 intravenous injection	M1-c6v1	M1-c6v1 will be administered through IV drip

Primary Outcome Measures

Name	Time	Method
Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors	About 2 years	Monitor the incidence of adverse events (TEAEs) during the study.
Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1.	About 2 years	Incidence of DLT
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.	About 2 years	Monitor the incidence of adverse events (TEAEs) during the study.

Secondary Outcome Measures

Name	Time	Method
Assess the immunogenicity of intravenous administration of M1-c6v1.	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.
Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.	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.
Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.	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.

Trial Locations

Locations (3)

National Hospital Organization Shikoku Cancer Center; 🇯🇵 Matsuyama-shi, Ehime, Japan

National Cancer Center Hospital East; 🇯🇵 Kashiwa-shi, Chiba, Japan

St. Marianna University Hospital; 🇯🇵 Kawasaki-shi, Kanagawa, Japan