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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

27

Participants

Timeline

Start Date

November 30, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Treatment-Refractory Solid Tumors
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bionoxx Inc.

INDUSTRY