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Treatment-Refractory Solid TumorsPhase 1NCT07190833

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

A Phase 1 study testing OTS-412, Hydroxyurea (HU) and Atezolizumab in people with Treatment-Refractory Solid Tumors, run by Bionoxx Inc. at 2 sites in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Treatment-Refractory Solid Tumors
What is being tested?
OTS-412, Hydroxyurea (HU) and Atezolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
2 sitesSouth Korea
Study dates
9 Mar 2026to Dec 2030
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 19 years of age or older
  • Diagnosed with a malignant solid tumor via histology or cytology, although a radiological diagnosis is permissible for hepatocellular carcinoma
  • Solid tumors that demonstrate limited response or resistant to SOC therapy, particularly when atezolizumab or other PD-L1 inhibitors, or PD-1 inhibitors are administered as monotherapy or in combination therapy. This may include, but not limited to, hepatocellular carcinoma, melanoma, renal cell carcinoma, urothelial carcinoma, biliary cancer, head and neck cancer, gastric cancer, breast cancer, colorectal cancer, and any solid tumor with microsatellite instability (MSI)-high status. At minimum, SOC treatment presented in the Protocol should have been received for each cancer type.
  • Patients with tumors that have known actionable molecular alterations (i.e. EGFR, ALK, BRAF, etc) must have progressed on targeted therapy.
  • Lesions that are deemed feasible for injection either directly (palpable subcutaneous tumors) or under ultrasound guidance (deep-seated tumors). Additionally, tumor(s) should not be adjacent or encasing vital structures such as major nerves or blood vessels, pericardium, gastrointestinal tract or other hollow organs, mucosal regions or spinal cord that could cause occlusion or compression in case of tumor swelling or erosion and major bleeding in the case of necrosis.
  • At least one measurable (longest diameter, LD ≥1 cm) and injectable tumor that has not been previously received local treatment on computed tomography (CT) or magnetic resonance imaging (MRI)
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  • The total volume of injectable tumor(s) should be 2 cm3 or more in 1x10E8 pfu dosing cohorts and 6 cm3 or more in 3x10E8 pfu dosing cohorts.
  • Life expectancy of 12 weeks or more
  • Eastern cooperative oncology group (ECOG) performance status is 0, 1, or 2
  • Adequate pulmonary function, such as baseline pulse oximetry of at least 92% on room air
  • Laboratory test results meet the following:
  • ANC ≥ 1,500 /μL
  • White blood cell (WBC) ≥ 2,500 /μL
  • Hemoglobin (Hb) ≥ 9.0 g/dL without packed red blood cell transfusion within the prior 2 weeks
  • Platelet ≥ 75,000 /μL without platelet transfusion
  • AST and ALT ≤ 5 × ULN
  • Total bilirubin ≤ 1.5 × ULN
  • Creatinine clearance ≥ 60 mL/minute (measured using Cockcroft-Gault formula).
  • LDH ≤ 3 × ULN
  • INR or aPTT ≤ 1.5 × ULN.
  • Voluntarily decided to participate in this clinical study and provided written consent

Who cannot join

  • Patients who have previously received talimogene laherparepvec (Imlygic) or any other oncolytic virus, have received any systemic or local anti-cancer therapy for tumors within 4 weeks prior to the first administration of the study drugs(C1D1), or have not recovered from the adverse events due to these therapies to at least Grade 1 severity or returned to baseline levels prior to C1D1, with the exceptions of any grade of alopecia and Grade 2 neuropathy.
  • Patients who have untreated symptomatic brain metastases, have treated brain metastases without evidence of stability or improvement on two scans at least two weeks apart, have leptomeningeal disease regardless of treatment, or have received anti-convulsants within the last 28 days.
  • Tumors adjacent to vital neurovascular structures or at risk of airway compromise in the event of post injection tumor swelling, bleeding, or inflammation. Patients with tumors near vital structures can be enrolled as long as they have other lesions that are appropriate for injection (these tumors near vital structures will not be injected).
  • History of other malignancies that developed within 5 years (However, cervical carcinoma in situ, basal cell carcinoma, or squamous cell skin cancer, and all cancers after 5 years since it was cured are acceptable.)
  • History of organ transplant surgery
  • Known significant immunodeficiency due to underlying illness (e.g., HIV/AIDS) and/or immune-suppressive medication including high-dose systemic corticosteroids (prednisone 20 mg/day or equivalent which is ongoing and/or was taken more than 4 weeks within the preceding 2 months of study treatment)
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  • History of or active autoimmune disease
  • Ongoing severe inflammatory skin disease (as determined by the Investigator) requiring medical treatment or history of severe eczema (as determined by the Investigator) requiring prior medical treatment
  • Anticoagulation or anti-platelet medication that cannot be withheld for the required period prior to and after the OTS-412 injection, specifically:
  • Coumadin for 7 days
  • Direct Factor Xa inhibitor (rivaroxaban, apixaban, edoxaban) for 4 days
  • Oral direct thrombin inhibitor (dabigatran) for 4 days
  • Aspirin, clopidogrel, ticagrelor for 7 days
  • Prasugrel for 9 days
  • Low molecular weight heparin for 24 hours
  • Unfractionated heparin for 12 hours Please contact the Sponsor for questions regarding the management of other antithrombotic agents prior to treatment.
  • Taking antiviral drugs (immunoglobulin, interferon, etc.) or being unable to discontinue these medications at least 7 days prior to receiving the study drugs (note that oral antiviral drugs for hepatitis B and C are allowed).
  • Severe medical conditions, as determined by the Investigator, that may increase the patient's susceptibility to adverse medical risks during or after OTS-412 treatment, such as volume loading, tachycardia, or hypotension.
  • Current or history of significant cardiovascular disease, including significant coronary artery disease (e.g., requiring angioplasty or stent), congestive heart failure within the preceding 12 months, myocardial infarction, ischemic cardiomyopathy, or myocarditis, unless cardiology consultation and clearance have been obtained for study participation
  • History of the side effects of past smallpox vaccinations
  • History of the hypersensitivity or severe/serious AEs to the components of the study drugs
  • Unable to receiving a contrast medium for a radiological scan due to a history of allergy to iodide contrast agents
  • Vaccination with live vaccines within 4 weeks before the first administration of the study drugs
  • Receiving an investigational product within 4 weeks prior to the first administration of the study drugs
  • Pregnant or breastfeeding women
  • Patient who does not consent to the use of appropriate contraceptive methods for at least 6 months, when the woman is of childbearing age, or at least 1 year, when the male patient's spouse is a woman of childbearing age, after the last administration of the study drugs
  • Other medical condition that in the judgement of the Investigator may increase the risk associated with study participation or may interfere with interpretation of study results and/or otherwise make the patient inappropriate for study participation
  • Patient unable or unwilling to comply with the protocol

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

KyungMi Min, Project Manager contact

+82-55-367-7457

kmmin@bionoxx.com

Dohyun Shin contact

dhshin@bionoxx.com

South Korea2 sites, 2 recruiting

  • Dong-A University Hospital

    Busan, 49201

    Principal Investigator, +82-51-240-2607, drosy@dau.ac.kr

    Sung Yong Oh

    Recruiting

  • Pusan National University Yangsan Hospital

    Busan, 50612

    Principal Investigator, +82-55-360-1424, kcs6283@naver.com

    Cheol Sik Kim

    Recruiting

Other trials in South Korea

About this study

Official title: A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Combination With Hydroxyurea or Hydroxyurea/Atezolizumab in Treatment-refractory Solid Tumor Patients

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.

Read the detailed description

The primary objective of this study is:

  • to evaluate the safety of OTS-412 monotherapy, combination therapy of OTS-412 and hydroxyurea, or combination therapy of OTS-412, hydroxyurea, and atezolizumab
  • to find an optimal dosage of hydroxyurea when used in combination with OTS 412. Hydroxyurea is currently used at dosages of 15-35 mg/kg/day for certain conditions, and the optimal dosage when combined with the oncolytic virus will be determined within this range.
  • to find an optimal dosage of OTS-412 when used in combined with hydroxyurea and atezolizumab.

The secondary objectives include evaluating anti-tumor effects, immune responses, and pharmacokinetics (PK) of OTS-412 in blood over time after administration.

This study focuses on various solid tumors that are resistant to standard therapies, particularly immune checkpoint inhibitors alone or in combination with other therapies.

Being tested
OTS-412, Hydroxyurea (HU), Atezolizumab
Keywords
Oncolytic vaccinia virus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OTS-412Drug

    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

  • AtezolizumabDrug

    1,200 mg, once, 1 cycle, IV

  • OTS-412Drug

    3×10E8 pfu, once, 1 cycle, IT

  • OTS-412Drug

    optimal dose, once, 1 cycle, IT

Study groups in NCT07190833
Study groupRoleWhat they receive
Cohort 1ExperimentalOTS412 1 * 10E8 pfu
Receives: Drug: OTS-412
Cohort 2ExperimentalOTS412 1 * 10E8 pfu + HU 15mg/kg/day
Receives: Drug: OTS-412; Drug: Hydroxyurea (HU)
Cohort 3ExperimentalOTS412 1 * 10E8 pfu + HU 25mg/kg/day
Receives: Drug: OTS-412; Drug: Hydroxyurea (HU)
Cohort 4ExperimentalOTS412 1 * 10E8 pfu + HU 35mg/kg/day
Receives: Drug: OTS-412; Drug: Hydroxyurea (HU)
Cohort 5ExperimentalOTS412 1 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg
Receives: Drug: OTS-412; Drug: Hydroxyurea (HU); Drug: Atezolizumab
Cohort 6ExperimentalOTS412 3 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg
Receives: Drug: Hydroxyurea (HU); Drug: Atezolizumab; Drug: OTS-412
Expansion cohortExperimentalOTS412 optimal dose + HU optimal dose + Atezolizumab 1200mg
Receives: Drug: Hydroxyurea (HU); Drug: Atezolizumab; Drug: OTS-412

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. RP2D of OTS-412 and HU combination with Atezolizumab

    Overall assessment of safety, tolerability, dose-limiting toxicities (DLTs), treatment-emergent adverse events (TEAEs), and available pharmacokinetic (PK), pharmacodynamic (PD), and preliminary antitumor activity data collected during the dose-escalation phase.

    Measured: Up to approximately 28 days after the last subject in each cohort completes the DLT evaluation period.

  2. Incidence and severity of adverse events (AEs)

    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

    Measured: From enrollment to 180 days after the last dose of the study drugs.

Secondary outcomes (5)

  1. Tumor response

    Determined by the Investigator according to RECIST v1.1 (or mRECIST for hepatocellular carcinoma) and/or iRECIST

    Measured: From enrollment to 28 days after the last dose of the study drugs

  2. Overall survival

    Defined as time from the study drug initiation to death from any cause

    Measured: Defined as time from the study drug initiation to death from any cause

  3. PK analysis

    Assessment of the concentration of OTS-412 genomic particles (qPCR) in blood over time

    Measured: From enrollment to Day 22

  4. Firefly Luciferase Activity-Based Immune Monitoring

    1. Rate of patients to achieve target absolute neutrophil count (ANC) level (between 1500 and 3000/μL)
    2. Changes in ANC over time
    3. Changes in lymphocytes count over time
    4. Changes in immunophenotype of lymphocytes over time
    5. Changes in serum cytokines (including but not limited to IL-1β, IL-6, INF-γ, TNF-α) over time

    Measured: 1. 7 days after OTS-412 administration 2. From enrollment to 180 days after the last dose of the study drugs. 3. From enrollment to 180 days after the last dose of the study drugs. 4. From enrollment to Day 22 5. From enrollment to Day 22

  5. Firefly Luciferase Activity-Based Immune Monitoring

    Assessment of tumor tissue histology and immunology, including immunological assays for T cells and programmed cell death ligand 1 (PD-L1) expression (optional)

    Neutralizing antibody measurement against OTS-412

    Firefly luciferase (FLuc) T cell response assessment

    Measured: From enrollment to Day 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Sep 2025
  2. Study start9 Mar 2026
  3. Primary completionDec 2028 (estimated)
  4. Study completionDec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
21 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07190833
Sponsor's protocol ID
OTS412-101(ROK)
Status last verified
Oct 2026
First submitted
17 Sep 2025
Last updated
4 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OTS-412, Hydroxyurea (HU) and Atezolizumab in people with Treatment-Refractory Solid Tumors, run by Bionoxx Inc. at 2 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact KyungMi Min, Project Manager (+82-55-367-7457, kmmin@bionoxx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

RP2D of OTS-412 and HU combination with Atezolizumab (time frame: Up to approximately 28 days after the last subject in each cohort completes the DLT evaluation period.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07190833.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.

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