RecruitingPhase 1NCT06046742

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

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

Sponsor

Guangzhou Virotech Pharmaceutical Co., Ltd.

Enrollment

12 participants

Start Date

Jul 10, 2024

Study Type

INTERVENTIONAL

Conditions

Solid Tumor

Summary

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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.

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