Treatment of advanced solid tumors with intravenous M1-c6v1

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase I clinical trial evaluates the safety and tolerability of M1-c6v1, an oncolytic virus, administered intravenously to patients with locally advanced or metastatic solid tumors. The study is open-label and employs a dose-escalation approach to assess the biological distribution, immunogenicity, and preliminary anti-tumor effects of the treatment. Participants will receive multiple IV injections while their responses and any adverse effects will be closely monitored.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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 contacts

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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.