A Study of Intravenous M1-c6v1 for Locally Advanced or Metastatic Solid Tumors
ConditionSolid Tumor
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorGuangzhou Virotech Pharmaceutical Co., Ltd.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
M1-c6v1
Biological/VaccineIntravenous drip administration
Treatment groups
12 Participants
are divided into 1 treatment groupGroup A: M1-c6v1 intravenous injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Evaluate 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 years2
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 years3
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 yearsSecondary outcomes
1
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 years2
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 years3
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.
Time frame
About 2 yearsSponsors and contacts
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Source ClinicalTrials.gov