NCT07170592

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

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: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (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	3×10E8 pfu, once q3 weeks, 3 cycles, IT
DRUG	Hydroxyurea (HU)	15 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Atezolizumab	1,200 mg, once q3 weeks, 2 cycles, IV
DRUG	OTS-412	3×10E8 pfu, once q3 weeks, 2 cycles, IT
DRUG	OTS-412	1×10E8 pfu, once q3 weeks, 2 cycles, IT
DRUG	Hydroxyurea (HU)	20 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	25 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	30 mg/kg/day, 14 days, 1 cycle, PO
DRUG	Hydroxyurea (HU)	35 mg/kg/day, 14 days q3 weeks, 2 cycles, PO
DRUG	OTS-412	optimal dose, once q3 weeks, 2 cycles, IT
DRUG	Hydroxyurea (HU)	optimal dose, 14 days q3 weeks, 2 cycles, PO

Timeline

• Start date: 2027-01-01
• Primary completion: 2028-12-01
• Completion: 2030-12-01
• First posted: 2025-09-12
• Last updated: 2026-04-07

Regulatory

• FDA-regulated drug study