Actively Recruiting
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)
Led by Bionoxx Inc. · Updated on 2026-04-09
27
Participants Needed
2
Research Sites
246 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients (South Korea)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 19 years of age or older
- Diagnosed with a malignant solid tumor via histology or cytology; radiological diagnosis allowed for hepatocellular carcinoma
- Solid tumors resistant or with limited response to standard therapies, including immune checkpoint inhibitors alone or combined
- Patients with tumors having actionable molecular alterations must have progressed on targeted therapy
- Tumors suitable for direct or ultrasound-guided injection, not adjacent to vital structures that could be harmed by swelling or bleeding
- At least one measurable and injectable tumor of at least 1 cm in longest diameter on CT or MRI
- Total volume of injectable tumors of at least 2 cm3 for 1x10E8 pfu dosing or 6 cm3 for 3x10E8 pfu dosing
- Life expectancy of at least 12 weeks
- ECOG performance status of 0, 1, or 2
- Adequate lung function with pulse oximetry of at least 92% on room air
- Laboratory tests meeting specific blood counts, liver and kidney function, coagulation, and LDH limits
- Provided voluntary written informed consent
You will not qualify if you...
- Prior treatment with talimogene laherparepvec or other oncolytic viruses
- Received systemic or local anti-cancer therapy within 4 weeks before first study drug dose or unresolved side effects from such therapies except alopecia or grade 2 neuropathy
- Untreated or unstable brain metastases or leptomeningeal disease
- Tumors adjacent to vital neurovascular structures or airway at risk from swelling or bleeding, unless other injectable lesions are present
- Other cancers diagnosed within past 5 years except certain skin and cervical cancers
- History of organ transplant
- Significant immunodeficiency or ongoing high-dose immunosuppressive therapy
- History or active autoimmune disease
- Severe inflammatory or eczema skin diseases requiring treatment
- Use of anticoagulant or antiplatelet drugs that cannot be paused for required times before and after OTS-412 injection
- Use of antiviral drugs that cannot be stopped at least 7 days before study drugs (except hepatitis B or C oral antivirals)
- Severe medical conditions increasing risk during or after OTS-412 treatment
- Significant cardiovascular disease unless cleared by cardiology
- History of adverse effects from smallpox vaccination
- Allergy or severe reaction to study drug components
- Unable to receive contrast medium for scans due to allergy
- Live vaccine within 4 weeks before first study drug dose
- Participation in another investigational study within 4 weeks before first study drug dose
- Pregnant or breastfeeding
- Not agreeing to use contraception for required periods after treatment
- Any other condition that may increase risk or interfere with study participation
- Unable or unwilling to follow study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Dong-A University Hospital
Busan, South Korea, 49201
Actively Recruiting
2
Pusan National University Yangsan Hospital
Busan, South Korea, 50612
Actively Recruiting
Research Team
Y
Younok Choi, Team Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
7
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here