Treatment of advanced solid tumors with intravenous M1-c6v1

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

This study is testing a new treatment using an oncolytic virus given through an IV to see if it can safely help people with advanced solid tumors.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Guangzhou Virotech Pharmaceutical Co., Ltd. (industry)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 3 sites (Kashiwa-shi, Chiba and 2 other locations)
• Trial ID: NCT06046742 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with locally advanced or metastatic solid tumors that are intolerable or refractory to standard therapy.

Not a fit: Patients with primary or acquired immunodeficiencies or those who have received anti-tumor treatment within the last four weeks may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced solid tumors who have not responded to standard therapies.

How similar studies have performed: While the use of oncolytic viruses is a novel approach, similar studies have shown promise in treating various cancers, indicating potential for success.

Eligibility criteria

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 this trial is running

Kashiwa-shi, Chiba and 2 other locations

• 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.

Conditions: Solid Tumor, M1-c6v1, Oncolytic Virus, VRT106