Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

Running, not enrolling · Phase 1

Conditions studied: Advanced Malignant Solid Tumor

In brief

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.

Key facts

Study ID

NCT06150183

Run by

BioNTech SE

People needed

41

Starts

2023-11-30

Expected to finish

2028-03-01

Last updated by the study team

2026-01-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.

You may not qualify if…

• 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.
• 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.

Where it is running

• START Midwest — Grand Rapids, Michigan, United States
• Carolina BioOncology Institute, LLC — Huntersville, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• GZA Ziekenhuizen — Antwerp, Belgium
• CHU de Liège — Liège, Belgium
• Rigshospitalet — Copenhagen, Denmark
• National Cancer Center Hospital East — Kashiwanoha, Japan
• Hospital Quironsalud Barcelona (NEXT Barcelona) — Barcelona, Spain
• Hospital Fund. Jiménez Dia — Madrid, Spain
• Hospital HM Univ. Sanchinarro, Ensayos START — Madrid, Spain
• Clinica Universidad de Navarra — Pamplona, Spain
• Royal Marsden Hospital - London — London, United Kingdom
• The Christie Hospital — Manchester, United Kingdom
• Northern Centre for Cancer Care — Newcastle, United Kingdom

Full record on ClinicalTrials.gov

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