Treatment-Refractory Solid TumorsPhase 1NCT07170592
A Phase 1 Study of OTS-412 (Recombinant Oncolytic Vaccinia Virus) in Treatment-refractory Solid Tumor Patients
A Phase 1 study testing OTS-412, Hydroxyurea (HU) and Atezolizumab in people with Treatment-Refractory Solid Tumors, run by Bionoxx Inc..
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
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to 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)
Show all 21Show fewer
- 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)
Show all 28Show fewer
- 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
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.
- Conditions
- Treatment-Refractory Solid Tumors
- Being tested
- OTS-412, Hydroxyurea (HU), Atezolizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OTS-412Drug
3×10E8 pfu, once q3 weeks, 3 cycles, IT
Hydroxyurea (HU)Drug
15 mg/kg/day, 14 days, 1 cycle, PO
AtezolizumabDrug
1,200 mg, once q3 weeks, 2 cycles, IV
OTS-412Drug
3×10E8 pfu, once q3 weeks, 2 cycles, IT
OTS-412Drug
1×10E8 pfu, once q3 weeks, 2 cycles, IT
Hydroxyurea (HU)Drug
20 mg/kg/day, 14 days, 1 cycle, PO
Hydroxyurea (HU)Drug
25 mg/kg/day, 14 days, 1 cycle, PO
Hydroxyurea (HU)Drug
30 mg/kg/day, 14 days, 1 cycle, PO
Hydroxyurea (HU)Drug
35 mg/kg/day, 14 days q3 weeks, 2 cycles, PO
OTS-412Drug
optimal dose, once q3 weeks, 2 cycles, IT
Hydroxyurea (HU)Drug
optimal dose, 14 days q3 weeks, 2 cycles, PO
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | OTS412 3 * 10E8 pfu + HU 15 ~ 20mg/kg/day Receives: Drug: OTS-412; Drug: Hydroxyurea (HU) |
| Cohort 2 | Experimental | OTS412 3 * 10E8 pfu + HU 25 ~ 30mg/kg/day Receives: Drug: OTS-412; Drug: Hydroxyurea (HU) |
| Cohort 3 | Experimental | OTS412 3 * 10E8 pfu + HU 35mg/kg/day Receives: Drug: OTS-412; Drug: Hydroxyurea (HU) |
| Cohort 4 | Experimental | OTS412 3 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg Receives: Drug: Atezolizumab; Drug: OTS-412; Drug: Hydroxyurea (HU) |
| Cohort 5 | Experimental | OTS412 1 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg Receives: Drug: Atezolizumab; Drug: OTS-412; Drug: Hydroxyurea (HU) |
| Expansion cohort | Experimental | OTS412 optimal dose + HU optimal dose + Atezolizumab 1200mg Receives: Drug: Atezolizumab; Drug: OTS-412; Drug: Hydroxyurea (HU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 180 days after the last dose of the study drugs.
Secondary outcomes (12)
Tumor response, as 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
Overall survival defined as time from the study drug initiation to death from any cause
Measured: From enrollment up to 15 years after end of study
PK analysis: Assessment of the concentration of OTS-412 genomic particles (qPCR) in blood over time
Measured: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Rate of patients to achieve target absolute neutrophil count (ANC) level (between 1500 and 3000/μL) 7 days after OTS-412 administration
Measured: 7 days after OTS-412 administration
Changes in ANC over time
Measured: From enrollment to 180 days after the last dose of the study drugs.
Changes in lymphocytes count over time
Measured: From enrollment to 180 days after the last dose of the study drugs.
Changes in immunophenotype of lymphocytes over time (Korean sites only)
Measured: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Changes in serum cytokines (including but not limited to IL-1β, IL-6, INF-γ, TNF-α) over time
Measured: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Assessment of tumor tissue histology and immunology, including immunological assays for T cells and programmed cell death ligand 1 (PD-L1) expression (optional)
Measured: From enrollment to 7 days after last study drug administration
Viral shedding analysis: Assessment of the presence of the virus in oral and urine samples
Measured: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Neutralizing antibody measurement against OTS-412
Measured: From enrollment to 6 weeks after first study drug administration
Firefly luciferase (FLuc) T cell response assessment (Korean sites only)
Measured: From enrollment to 6 weeks after first study drug administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2025
- Study startJan 2027 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment-Refractory Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bionoxx Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07170592
- Sponsor's protocol ID
- OTS412-101
- Status last verified
- Aug 2026
- First submitted
- 30 Jul 2025
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07170592
- Acronym / sponsor ID
- OTS412-101
- Conditions
- Treatment-Refractory Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Bionoxx Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 3 * 10E8 pfu + HU 15 ~ 20mg/kg/day |
| Cohort 2 | Experimental | Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 3 * 10E8 pfu + HU 25 ~ 30mg/kg/day |
| Cohort 3 | Experimental | Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 3 * 10E8 pfu + HU 35mg/kg/day |
| Cohort 4 | Experimental | Drug: Atezolizumab, Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 3 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg |
| Cohort 5 | Experimental | Drug: Atezolizumab, Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 1 * 10E8 pfu + HU optimal dose + Atezolizumab 1200mg |
| Expansion cohort | Experimental | Drug: Atezolizumab, Drug: OTS-412, Drug: Hydroxyurea (HU)OTS412 optimal dose + HU optimal dose + Atezolizumab 1200mg |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OTS-4123×10E8 pfu, once q3 weeks, 3 cycles, IT | Drug | Cohort 1 |
| Hydroxyurea (HU)15 mg/kg/day, 14 days, 1 cycle, PO | Drug | Cohort 1 |
| Atezolizumab1,200 mg, once q3 weeks, 2 cycles, IV | Drug | Cohort 4, Cohort 5, Expansion cohort |
| OTS-4123×10E8 pfu, once q3 weeks, 2 cycles, IT | Drug | Cohort 2, Cohort 3, Cohort 4 |
| OTS-4121×10E8 pfu, once q3 weeks, 2 cycles, IT | Drug | Cohort 5 |
| Hydroxyurea (HU)20 mg/kg/day, 14 days, 1 cycle, PO | Drug | Cohort 1 |
| Hydroxyurea (HU)25 mg/kg/day, 14 days, 1 cycle, PO | Drug | Cohort 2 |
| Hydroxyurea (HU)30 mg/kg/day, 14 days, 1 cycle, PO | Drug | Cohort 2 |
| Hydroxyurea (HU)35 mg/kg/day, 14 days q3 weeks, 2 cycles, PO | Drug | Cohort 3 |
| OTS-412optimal dose, once q3 weeks, 2 cycles, IT | Drug | Expansion cohort |
| Hydroxyurea (HU)optimal dose, 14 days q3 weeks, 2 cycles, PO | Drug | Cohort 4, Cohort 5, Expansion cohort |
Primary outcome
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.
12 secondary outcomes
Tumor response, as determined by the Investigator according to RECIST v1.1 (or mRECIST for hepatocellular carcinoma) and/or iRECIST
Time frame: From enrollment to 28 days after the last dose of the study drugs
Overall survival defined as time from the study drug initiation to death from any cause
Time frame: From enrollment up to 15 years after end of study
PK analysis: Assessment of the concentration of OTS-412 genomic particles (qPCR) in blood over time
Time frame: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Rate of patients to achieve target absolute neutrophil count (ANC) level (between 1500 and 3000/μL) 7 days after OTS-412 administration
Time frame: 7 days after OTS-412 administration
Changes in ANC over time
Time frame: From enrollment to 180 days after the last dose of the study drugs.
Changes in lymphocytes count over time
Time frame: From enrollment to 180 days after the last dose of the study drugs.
Changes in immunophenotype of lymphocytes over time (Korean sites only)
Time frame: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Changes in serum cytokines (including but not limited to IL-1β, IL-6, INF-γ, TNF-α) over time
Time frame: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Assessment of tumor tissue histology and immunology, including immunological assays for T cells and programmed cell death ligand 1 (PD-L1) expression (optional)
Time frame: From enrollment to 7 days after last study drug administration
Viral shedding analysis: Assessment of the presence of the virus in oral and urine samples
Time frame: From enrollment to Cycle 2 Day 1(each cycle is 21 days)
Neutralizing antibody measurement against OTS-412
Time frame: From enrollment to 6 weeks after first study drug administration
Firefly luciferase (FLuc) T cell response assessment (Korean sites only)
Time frame: From enrollment to 6 weeks after first study drug administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
Related trials for Treatment-Refractory Solid Tumors
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing MLN0128 (TAK-228) as Potentially Targeted Treatment in Cancers With TSC1 or TSC2 Genetic Changes (MATCH - Subprotocol M)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing LOXO-101 as Potentially Targeted Treatment in Cancers With NTRK Genetic Changes (MATCH - Subprotocol Z1E)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
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..
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: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Dohyun Shin, Project Manager (+82-55-367-7457, dhshin@bionoxx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.