drugset
drugset / Trial / NCT07170592

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients

NCT07170592 ↗

Phase 1 Not yet recruiting 24 enrolled Bionoxx Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This clinical trial aims to determine whether the administration of the investigational drug OTS-412, OTS-412 in combination with hydroxyurea or hydroxyurea/atezolizumab is safe and effective for patients with various types of cancer.

Timeline

Start
2027-01
Primary completion
2028-12
Completion
2030-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Atezolizumab Monoclonal antibody 1200 mg Intravenous
Subject Hydroxyurea Other / unclassified 15 mg/kg Oral
Subject Hydroxyurea Other / unclassified 20 mg/kg Oral
Subject Hydroxyurea Other / unclassified 25 mg/kg Oral
Subject Hydroxyurea Other / unclassified 30 mg/kg Oral
Subject Hydroxyurea Other / unclassified 35 mg/kg Oral
Subject OTS-412 Unknown 1e+08 unknown Intrathecal
Subject OTS-412 Unknown 3e+08 unknown Intrathecal

Indications

refractory malignant neoplasm