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

Guangzhou Virotech Pharmaceutical

Status and phase: Enrolling; Phase 1

Conditions: Solid Tumor

Treatments: Biological: M1-c6v1

Study type: Interventional

Funder types: Industry

Identifiers

NCT06046742

VRT106-J01

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

M1-c6v1 intravenous injection

Experimental group

Description:

M1-c6v1 will be administered through IV drip

Treatment:

Biological: M1-c6v1