Advanced Malignant Solid TumorPhase 1NCT06150183
Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors
A Phase 1 study testing BNT314 in people with Advanced Malignant Solid Tumor, run by BioNTech SE at 14 sites in 6 countries.
Trial summary
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer. This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Tumor
- What is being tested?
- BNT314
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 14 sitesin 6 countries
- Study dates
- 30 Nov 2023to Nov 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures.
- Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
- Are ≥18 years of age at the time of giving informed consent.
- Have measurable disease according to RECIST v1.1.
- Have a life expectancy of >3 months.
- Have Eastern Cooperative Oncology Group Performance Status score of 0 or 1 at screening.
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- Have adequate coagulation function at screening as determined by:
- International normalized ratio or prothrombin time ≤1.5 × upper limit normal (ULN; unless on therapeutic anticoagulants with values within therapeutic window).
- Activated partial thromboplastin time ≤1.5 × ULN (unless on therapeutic anticoagulants with values within therapeutic window).
- Have adequate bone marrow/hematologic function at screening as determined by:
- Absolute neutrophil count (ANC) ≥1.5 × 10^9/L (≥1500/μL) (patients may not use granulocyte colony stimulating factor or granulocyte-macrophage colony stimulating factor to achieve these ANC levels in the past 7 days).
- Platelet count ≥100 × 10^9/L (≥100,000/μL).
- Hemoglobin ≥9 g/dL.
- Any blood transfusions ≤28 days before first dose of study treatment should be documented.
- Have adequate hepatic function at screening as determined by:
- Total bilirubin (Tbili) ≤1.5 × ULN OR direct bilirubin ≤ULN for patients with Tbili levels >1.5 × ULN. Patients with Gilbert's syndrome must have a Tbili <3 mg/dL and direct bilirubin ≤ULN.
- Alanine aminotransferase and aspartate aminotransferase ≤2.5 ULN for patients with or without liver metastases.
- Albumin ≥30 g/L.
- Have adequate renal function at screening as determined by glomerular filtration rate ≥45 mL/min/1.73 m^2 according to the abbreviated Modification of Diet in Renal Disease equation.
- Have adequate pancreas function at screening as determined by amylase and lipase with no signs and symptoms of pancreatitis.
- Patients of childbearing potential (POCBP) must have a negative urine or blood beta human chorionic gonadotropin test at screening. Patients that are postmenopausal or permanently sterilized (verified by medical records) will not be considered POCBP, and therefore are not required to undergo pregnancy testing.
- POCBP must agree to practice a highly effective form of contraception and to require their male partners to use condoms coated with a spermicidal agent, starting at Visit D1 and thereafter until 120 days after receiving the last study treatment.
- POCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during study, starting at Visit D1 and thereafter until 120 days after receiving the last study treatment.
- Males who are sexually active and have not had a bilateral vasectomy or orchidectomy must agree to use condoms coated with a spermicidal agent and to require their female partners to practice a highly effective form of contraception during the study, starting at Visit D1 and thereafter until 120 days after receiving the last study treatment.
- Males must be willing to refrain from sperm donation, starting at Visit D1 and thereafter until 120 days (one sperm cycle) after receiving the last study treatment.
- Patients must have a histologically confirmed advanced malignant solid tumor, having experienced disease progression on or after standard therapy, or were intolerant of or not eligible for standard therapy.
- Other inclusion criteria specific to selected tumor indications may apply.
Who cannot join
- Patients that have uncontrolled intercurrent illness, including but not limited to:
- Ongoing or active infection requiring treatment with anti-infective therapy administered less than 2 weeks prior to first dose.
- Symptomatic congestive heart failure (Grade III or IV as classified by the New York Heart Association), unstable angina pectoris, or symptomatic untreated cardiac arrhythmia. Treated and/or asymptomatic cardiac arrythmia/atrial fibrillation will be allowed.
- History of arterial thrombosis or pulmonary embolism within 6 months before the first dose of study treatment.
- History of myocardial infarction within 6 months before the first dose of study treatment.
- Uncontrolled hypertension defined as systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg, despite optimal medical management.
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- Prolonged QTc interval at baseline of ≥470 milliseconds using Fridericia's QT correction formula.
- Ongoing or recent (within one year of screening) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events.
- History of:
- Grade 2 immune-mediated myocarditis/colitis/pneumonitis that led to checkpoint inhibitor (CPI) discontinuation. Patients experiencing other Grade 2 immune-mediated adverse events that led to CPI discontinuation, require discussion with the sponsor.
- Any Grade ≥3 immune-mediated adverse events that led to CPI discontinuation.
- Patients with Grade 3 adverse events that led to CPI discontinuation but resolved within 21 days without sequalae may also be considered for discussion with the sponsor.
- History of chronic liver disease (e.g., alcoholic hepatitis or nonalcoholic steatohepatitis, drug-related or autoimmune hepatitis) or evidence of hepatic cirrhosis.
- History of non-treated intracerebral arteriovenous malformation (shunts), non-treated cerebral aneurysm, spinal cord compression (from disease), carcinomatous meningitis, or stroke will be excluded.
- History of acute or chronic pancreatitis of any etiology within 6 weeks prior to the start of study treatment.
- Ongoing pneumonitis or history of noninfectious pneumonitis that has required steroids or evidence of interstitial lung disease.
- Transient ischemic attack less than one month prior to screening will be excluded.
- History of brain/central nervous system (CNS) metastases. Patients with newly identified or known unstable or symptomatic CNS metastases will be excluded. Patients with previously treated brain metastases are allowed provided lesions are radiologically stable (i.e., without evidence of progression) for at least 28 days by repeat imaging, latest imaging performed maximum 6 weeks prior to Cycle 1, Day 1.
- Serious, non-healing wound, skin ulcer (of any grade), or bone fracture will be excluded.
- Other concurrent severe and/or uncontrolled medical condition that would, in the investigator's judgment, contraindicate patient participation in this clinical study (e.g., acute or chronic pancreatitis, active hepatitis). Known primary immunodeficiencies, either cellular (e.g., DiGeorge syndrome, T-cell negative severe combined immunodeficiency [SCID] or combined T- and B-cell immunodeficiencies (e.g., T- and B-cell negative SCID, Wiskott Aldrich syndrome, ataxia telangiectasia, common variable immunodeficiency).
- Major surgery within 3 weeks before signature of the ICF unless fully recovered from the surgery in the opinion of the investigator.
- Any positive test for hepatitis B (defined as positive for hepatitis B surface antigen or hepatitis B virus DNA), indicating acute or chronic infection.
- Any positive test for hepatitis C (defined as positive for hepatitis C virus antibody or hepatitis C virus RNA), indicating acute or chronic infection.
- Prior therapy:
- Radiotherapy within 14 days prior to first BNT314 administration. Palliative radiotherapy will be allowed, but not to target lesions.
- Any epithelial cell adhesion molecule- or 4-1BB-targeting treatment.
- Treatment with an anticancer agent within 4 weeks or for systemic therapies after at least five half-lives of the drug, whichever is shorter, prior to study treatment administration.
- Patient has received any investigational agent (including investigational vaccines) or used an invasive investigational medical device within 28 days before the planned first dose of BNT314 or is currently enrolled in an (another) interventional study. Patients who are in the follow-up phase of an interventional study may participate if they have not received an investigational agent within 28 days (or five half-lives, whichever is longer) of the first dose of BNT314.
- Patient has a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone or equivalent) or other immunosuppressive medications within 14 days of the first dose of BNT314. Inhaled or topical steroids, and adrenal or pituitary replacement steroid >10 mg daily prednisone or equivalent, are permitted in the absence of active autoimmune disease.
- Patient has received granulocyte or granulocyte/macrophage colony stimulating factor (G-CSF/GM-CSF) support within 4 weeks prior to first BNT314 administration or is chronically transfusion dependent; G-CSF and other hematopoietic factors may be used in the management of acute toxicity (such as febrile neutropenia) or prophylactically, when clinically indicated at the investigator's discretion.
- Received any live vaccine within 30 days prior to the start of study treatment.
- Known alcohol dependency within 6 months enrollment in this study.
- Planned enrollment in another study of an IMP, starting after Visit D1 and continuously until the last planned visit in this study.
- Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study, or that could prevent, limit, or confound the protocol specified assessments or procedures, or that could impact adherence to protocol-described requirements.
- Are subject to exclusion periods from another investigational study.
- Are vulnerable individuals as per International Council for Harmonisation E6 definition, i.e., are individuals whose willingness to participate in a clinical study may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
- Has contraindications (known allergies, hypersensitivity, or intolerance) to the use of BNT314. A patient with a history of hypersensitivity to any component/excipients of BNT314 is also excluded.
- Are pregnant or breastfeeding and cannot discontinue breastfeeding for the duration of the study and for 4 months after receiving the last dose of BNT314.
Trial locations and contacts
14 sites in 6 countries.
14 sites in 6 countries
Spain4 sites
Hospital Quironsalud Barcelona (NEXT Barcelona)
Barcelona, 08023
Hospital Fund. Jiménez Dia
Madrid, 28040
Hospital HM Univ. Sanchinarro, Ensayos START
Madrid, 28050
Clinica Universidad de Navarra
Pamplona, 31008
United States3 sites
Cleveland Clinic
Cleveland, Ohio, 44195
START Midwest
Grand Rapids, Michigan, 49546
Carolina BioOncology Institute, LLC
Huntersville, North Carolina, 28078
United Kingdom3 sites
Royal Marsden Hospital - London
London, SW36JJ
The Christie Hospital
Manchester, M20 4BX
Northern Centre for Cancer Care
Newcastle, NE7 7DN
About this study
Official title: A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 as Monotherapy in Patients With Advanced Malignant Solid Tumors
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer.
This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.
Read the detailed description
This is a multicenter, multinational safety study in patients with metastatic or advanced malignant solid tumors for whom, at the discretion of the investigator, there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BNT314.
During dose escalation, BNT314 will be administered to patients via one infusion in periodic cycles.
Additional cohorts (backfill cohorts) administering BNT314 as monotherapy will assign patients to specific DLs, based on the emerging safety, PK, and pharmacodynamic data. This would allow for further assessment of dose- and exposure-response relationships for clinical activity, safety, and tolerability to support BNT314 dose optimization.
The treatment period will last until progressive disease (PD), confirmed PD (as per immune Response Evaluation Criteria in Solid Tumors [iRECIST]), unacceptable toxicity, or withdrawal of consent, whichever happens first.
The maximum duration of BNT314 administration in this study is 2 years.
- Conditions
- Advanced Malignant Solid Tumor
- Being tested
- BNT314
- Keywords
- Malignant solid tumors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BNT314Biological
Intravenous infusion
| Study group | Role | What they receive |
|---|---|---|
| BNT314 Monotherapy | Experimental | Escalating dose levels and backfill cohorts Receives: Biological: BNT314 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose-limiting toxicity within a cohort
Measured: 21 days from the first dose administration
Number and percentage of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship
In patients receiving at least one dose of BNT314 per cohort
Measured: from first dose of study treatment to 90 days after last dose of study treatment
Number and percentage of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE
In patients receiving at least one dose of BNT314 per cohort
Measured: from first dose of study treatment to 90 days after last dose of study treatment
Number and percentage of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters
In patients receiving at least one dose of BNT314 per cohort
Measured: from first dose of study treatment to 90 days after last dose of study treatment
Secondary outcomes (7)
Geometric means of area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose (AUClast)
In patients receiving at least one dose of BNT314 per cohort and are evaluable for PK assessments
Measured: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of area under the concentration-time curve from pre-dose to the end of the dosing period (AUCtau)
In patients receiving at least one dose of BNT314 per cohort and are evaluable for PK assessments
Measured: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of maximum concentration (Cmax) from pre-dose to the end of the dosing period
In patients receiving at least one dose of BNT314 per cohort and are evaluable for PK assessments
Measured: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Number and percentage of patients who developed detectable anti-drug antibody from baseline to the end of study treatment
In patients receiving at least one dose of BNT314 per cohort
Measured: from pre-dose to 90 days after last dose of study treatment
Disease control rate based on investigator's tumor assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Reported with number and percentage of patients with a confirmed complete response (CR), partial response (PR), or stable disease (SD) (assessed at least 6 weeks after first dose of study treatment) as best overall response. In patients receiving at least one dose of BNT314
Measured: up to 3 years after first dose of study treatment
Objective response rate based on investigator's tumor assessment according to RECIST v1.1
Reported with number and percentage of patients with a confirmed CR or PR as best overall response. In patients receiving at least one dose of BNT314.
Measured: up to 3 years after first dose of study treatment
Duration of response (DOR) based on investigator's tumor assessment according to RECIST v1.1
DOR is defined as the time from first objective response (CR or PR) to first occurrence of objective tumor progression or death from any cause, whichever occurs first. In patients receiving at least one dose of BNT314.
Measured: up to 3 years after first dose of study treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start30 Nov 2023
- Primary completion18 Aug 2026
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid TumorStudies of the same condition, open and under way.
- More trials run by BioNTech SEThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioNTech SE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Genmab
- Responsible party
- Sponsor
- Investigators
- BioNTech Responsible Person, Study director, BioNTech SE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150183
- Sponsor's protocol ID
- BNT314-01
- Other IDs
- 2023-506053-38-00, 1008686, 2023
- Status last verified
- Sep 2026
- First submitted
- 21 Nov 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A First-in-Human, Open-label, Dose Escalation Trial With Expansion Cohorts to Evaluate the Safety and Preliminary Efficacy of BNT314 as Monotherapy in Patients With Advanced Malignant Solid Tumors
- ClinicalTrials.gov ID
- NCT06150183
- Acronym / sponsor ID
- BNT314-01
- Conditions
- Advanced Malignant Solid Tumor
- Keywords
- Malignant solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 41 participants (actual)
- Lead sponsor
- BioNTech SEIndustry (pharma, biotech, devices)
- Collaborators
- Genmab
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 18 Aug 2026 (actual)
- Study completion
- Nov 2026 (estimated)
- First posted
- 29 Nov 2023 (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.
The purpose of this first-in-human study is to find out if BNT314 is safe when it is used alone in patients with different types of cancer.
This is a dose escalation study in which patients will be assigned to multiple dose levels (DLs) of BNT314 given alone. By escalating the dose with a small group of patients, the Maximum Tolerated Dose which is the highest dose with acceptable safety and manageable side effects, or the maximum administered dose will be investigated.
Detailed description
This is a multicenter, multinational safety study in patients with metastatic or advanced malignant solid tumors for whom, at the discretion of the investigator, there is no available standard therapy likely to confer clinical benefit, evaluating the safety, tolerability, preliminary antitumor activity, pharmacokinetics (PK), pharmacodynamics, and immunogenicity of BNT314.
During dose escalation, BNT314 will be administered to patients via one infusion in periodic cycles.
Additional cohorts (backfill cohorts) administering BNT314 as monotherapy will assign patients to specific DLs, based on the emerging safety, PK, and pharmacodynamic data. This would allow for further assessment of dose- and exposure-response relationships for clinical activity, safety, and tolerability to support BNT314 dose optimization.
The treatment period will last until progressive disease (PD), confirmed PD (as per immune Response Evaluation Criteria in Solid Tumors [iRECIST]), unacceptable toxicity, or withdrawal of consent, whichever happens first.
The maximum duration of BNT314 administration in this study is 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BNT314 Monotherapy | Experimental | Biological: BNT314Escalating dose levels and backfill cohorts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any study-specific procedures.
- Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the study. This includes that they are able to understand and follow study-related instructions.
- Are ≥18 years of age at the time of giving informed consent.
- Have measurable disease according to RECIST v1.1.
- Have a life expectancy of >3 months.
Key exclusion criteria (38 listed)
- Patients that have uncontrolled intercurrent illness, including but not limited to:
- Prior therapy:
- Known alcohol dependency within 6 months enrollment in this study.
- Planned enrollment in another study of an IMP, starting after Visit D1 and continuously until the last planned visit in this study.
- Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the study, or that could prevent, limit, or confound the protocol specified assessments or procedures, or that could impact adherence to protocol-described requirements.
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 |
|---|---|---|
| BNT314Intravenous infusion | Biological | BNT314 Monotherapy |
Primary outcome
Occurrence of dose-limiting toxicity within a cohort
Time frame: 21 days from the first dose administration
Number and percentage of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade ≥ 3, serious, fatal TEAE by relationship
Time frame: from first dose of study treatment to 90 days after last dose of study treatment
In patients receiving at least one dose of BNT314 per cohort
Number and percentage of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE
Time frame: from first dose of study treatment to 90 days after last dose of study treatment
In patients receiving at least one dose of BNT314 per cohort
Number and percentage of patients with occurrence of Grade ≥ 3 abnormal safety laboratory parameters
Time frame: from first dose of study treatment to 90 days after last dose of study treatment
In patients receiving at least one dose of BNT314 per cohort
7 secondary outcomes
Geometric means of area under the concentration-time curve from pre-dose to last quantifiable time point prior to the next dose (AUClast)
Time frame: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of area under the concentration-time curve from pre-dose to the end of the dosing period (AUCtau)
Time frame: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Geometric means of maximum concentration (Cmax) from pre-dose to the end of the dosing period
Time frame: from pre-dose to 21 days after study treatment for Cycle 1 and Cycle 2
Number and percentage of patients who developed detectable anti-drug antibody from baseline to the end of study treatment
Time frame: from pre-dose to 90 days after last dose of study treatment
Disease control rate based on investigator's tumor assessment according to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Time frame: up to 3 years after first dose of study treatment
Objective response rate based on investigator's tumor assessment according to RECIST v1.1
Time frame: up to 3 years after first dose of study treatment
Duration of response (DOR) based on investigator's tumor assessment according to RECIST v1.1
Time frame: up to 3 years after first dose of study treatment
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 15 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
BioNTech Responsible Person study director
BioNTech SE
14 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BNT314 in people with Advanced Malignant Solid Tumor, run by BioNTech SE at 14 sites in 6 countries.
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 27 inclusion and 38 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Spain, United States, United Kingdom, Belgium, Denmark and 1 more country. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of dose-limiting toxicity within a cohort (time frame: 21 days from the first dose administration). The study lists 4 primary outcomes in all. 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 15 Sep 2026.