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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Intravenous drip administration
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
RECRUITINGNational Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan
RECRUITINGSt. Marianna University Hospital
Kawasaki-shi, Kanagawa, Japan
RECRUITINGEvaluate 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.
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.
Incidence of DLT
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.
Monitor the incidence of adverse events (TEAEs) during the study.
Time frame: About 2 years
Examine the biological distribution characteristics and shedding patterns of intravenously administered M1-c6v1.
Measure the distribution and shedding of M1-c6v1 following intravenous injection by detecting its presence in blood, saliva, urine, nasal swabs, and feces using qPCR (quantitative polymerase chain reaction) method.
Time frame: About 2 years
Assess the immunogenicity of intravenous administration of M1-c6v1.
Detect the presence of neutralizing antibodies against M1-c6v1 and assess their titers, which represent the potency of the neutralizing antibodies, using the PD50 value.
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.
Based on the specific tumor types, assess the ORR (Objective Response Rate) and DCR (Disease Control Rate) using RECIST (Response Evaluation Criteria in Solid Tumors) v1.1 or mRECIST (modified Response Evaluation Criteria in Solid Tumors) criteria.
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Time frame: About 2 years