NCT07190833

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

A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Combination With Hydroxyurea or Hydroxyurea/Atezolizumab in Treatment-refractory Solid Tumor Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: Bionoxx Inc. · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The primary objective of this study is: * to evaluate the safety of OTS-412 monotherapy, combination therapy of OTS-412 and hydroxyurea, or combination therapy of OTS-412, hydroxyurea, and atezolizumab * to find an optimal dosage of hydroxyurea when used in combination with OTS 412. Hydroxyurea is currently used at dosages of 15-35 mg/kg/day for certain conditions, and the optimal dosage when combined with the oncolytic virus will be determined within this range. * to find an optimal dosage of OTS-412 when used in combined with hydroxyurea and atezolizumab. The secondary objectives include evaluating anti-tumor effects, immune responses, and pharmacokinetics (PK) of OTS-412 in blood over time after administration. This study focuses on various solid tumors that are resistant to standard therapies, particularly immune checkpoint inhibitors alone or in combination with other therapies.

Conditions

• Treatment-Refractory Solid Tumors

Interventions

Type	Name	Description
DRUG	OTS-412	1×10E8 pfu, once, 1 cycle, IT
DRUG	Hydroxyurea (HU)	15 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	25 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	35 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	optimal dose, 14 days, 1 cycle, PO
DRUG	Atezolizumab	1,200 mg, once, 1 cycle, IV
DRUG	OTS-412	3×10E8 pfu, once, 1 cycle, IT
DRUG	OTS-412	optimal dose, once, 1 cycle, IT

Timeline

• Start date: 2026-03-09
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2025-09-24
• Last updated: 2026-04-09

Locations

2 sites across 1 country: South Korea