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

Sponsor
Bionoxx Inc.
Study ID
NCT07190833
Phase
PHASE1
Status
Recruiting
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Conditions

  • Treatment-Refractory Solid Tumors

Eligibility Criteria

Sex
ALL
Age
19 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Mar 9, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2028
Completion
Dec 31, 2030

Study Design

Enrollment
27 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    OTS412 1 \* 10E8 pfu
  • Experimental: Cohort 2
    OTS412 1 \* 10E8 pfu + HU 15mg/kg/day
  • Experimental: Cohort 3
    OTS412 1 \* 10E8 pfu + HU 25mg/kg/day
  • Experimental: Cohort 4
    OTS412 1 \* 10E8 pfu + HU 35mg/kg/day
  • Experimental: Cohort 5
    OTS412 1 \* 10E8 pfu + HU optimal dose + Atezolizumab 1200mg
  • Experimental: Cohort 6
    OTS412 3 \* 10E8 pfu + HU optimal dose + Atezolizumab 1200mg
  • Experimental: Expansion cohort
    OTS412 optimal dose + HU optimal dose + Atezolizumab 1200mg

Primary Outcome Measure

Incidence and severity of adverse events (AEs) per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0 or higher in OTS 412, OTS-412/HU combination, and OTS 412/HU/atezolizumab combination treatment [ Time Frame: From enrollment to 180 days after the last dose of the study drugs. ]

Central Contacts