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
Qualifiers
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
Treatments tested in this trial
- M1-c6v1
Treatment groups
12 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov