NCT06046742

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
8mo left

Started Jul 2024

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

September 12, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

July 10, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2026

Last Updated

March 13, 2025

Status Verified

December 1, 2024

Enrollment Period

2 years

First QC Date

September 12, 2023

Last Update Submit

March 10, 2025

Conditions

Solid Tumor

Keywords

M1-c6v1Solid TumorOncolytic VirusVRT106

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (3)

  • Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.

    About 2 years

  • Assess the immunogenicity of intravenous administration of M1-c6v1.

    About 2 years

  • Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators.

    About 2 years

Study Arms (1)

M1-c6v1 intravenous injection

EXPERIMENTAL

M1-c6v1 will be administered through IV drip

Biological: M1-c6v1

Interventions

M1-c6v1BIOLOGICAL

Intravenous drip administration

M1-c6v1 intravenous injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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 any anti-tumor treatment 4 weeks before using the IMP, including chemotherapy, biological therapy, endocrine therapy, targeted therapy, immunotherapy.
  • 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.
  • Subject has received immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

National Cancer Center Hospital East

Kashiwa-shi, Chiba, Japan

RECRUITING

National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

RECRUITING

St. Marianna University Hospital

Kawasaki-shi, Kanagawa, Japan

RECRUITING

Study Officials

  • Guangzhou Virotech Pharmaceutical Co., Ltd.

    Guangzhou Virotech Pharmaceutical Co., Ltd.

    STUDY CHAIR

Central Study Contacts

Guangzhou Virotech Pharmaceutical Co., Ltd.

CONTACT

+86-020-32030725clinicaltrialinfo@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

September 12, 2023

First Posted

September 21, 2023

Study Start

July 10, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

December 20, 2026

Last Updated

March 13, 2025

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations

JP(3)