A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: M1-c6v1.
- Who it may be relevant to
- Registry conditions: Solid Tumor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Biological M1-c6v1
Intravenous drip administration
Primary outcome measures
- Evaluate the safety and tolerability of escalating doses of intravenous M1-c6v1 in Patients with advanced malignant tumors [Time frame: About 2 years]
- Evaluate dose-limiting toxicities (DLTs) and determine the recommended phase 2 dose (RP2D) of single-agent intravenous administration of M1-c6v1. [Time frame: 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. [Time frame: About 2 years]
Secondary outcome measures (3)
- Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1. [Time frame: About 2 years]
- Assess the immunogenicity of intravenous administration of M1-c6v1. [Time frame: About 2 years]
- Assess the anti-tumor effect of M1-c6v1, including objective response rate (ORR) and disease control rate (DCR) as efficacy indicators. [Time frame: About 2 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 3 centers
- National Cancer Center Hospital East — Kashiwa-shi
- National Hospital Organization Shikoku Cancer Center — Matsuyama
- St. Marianna University Hospital — Kawasaki-shi
Identifiers
NCT: NCT06046742 · VRT106-J01