MedTrace Logo

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

NCT07170592 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-04-07

No results posted yet for this study

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.

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 & Collaborators

  • Bionoxx Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-01-31
Primary Completion
2028-12-31
Completion
2030-12-31
FDA Drug
Yes

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07170592 on ClinicalTrials.gov