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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2030

Conditions
Treatment-Refractory Solid Tumors
Interventions
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

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Bionoxx Inc.

INDUSTRY