A Study of Recombinant Oncolytic Virus M1(VRT106) in Patients With Solid Tumors

Recruiting now · Phase 1

Conditions studied: Solid Tumor

In brief

To Evaluate the safety and tolerability of single and multiple intratumoral injections of recombinant oncolytic virus M1 (VRT106) in patients with locally advanced/metastatic solid tumors.

Key facts

Study ID

NCT06368921

Run by

Guangzhou Virotech Pharmaceutical Co., Ltd.

People needed

30

Starts

2024-06-19

Expected to finish

2026-12-01

Last updated by the study team

2025-12-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 18-75 years of age, inclusive, at the Screening Visit.
• Subjects must have histological or cytological diagnosis of locally advanced or metastatic solid tumors who are intolerable or refractory to the standard therapy.
• Have at least one injectable lesion.
• An Eastern Cooperative Oncology Group (ECOG) score of 0-1.
• An estimated survival time of ≥ 12 weeks.

You may not qualify if…

• Subject has received any anti-tumor treatment 4 weeks before using the IMP.
• Subject has received any prior oncolytic viruses or other gene therapies.
• 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 immunomodulatory drugs, including but not limited to thymosin, IL-2, IFN, etc. within 14 days prior to first administration of IMP.

Where it is running

• Sun Yat-sen University Cancer Center — Guangzhou, Guangdong, China (enrolling)
• Affiliated Cancer Hospital of Zhengzhou University — Zhengzhou, Henan, China (enrolling)
• Affiliated Cancer Hospital of Shandong First Medical University — Jinan, Shandong, China (enrolling)

Full record on ClinicalTrials.gov

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