Safety and preliminary efficacy of BNT314 in cancer patients with malignant solid tumors

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• Patients are not eligible for enrollment in this trial if any of the following criteria apply: Patients that have uncontrolled intercurrent illness, including but not limited to: • Ongoing or active infection requiring treatment with anti-infective therapy administered less than two 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 (AF) will be allowed. • History of arterial thrombosis or pulmonary embolism within six months before the first dose of trial treatment. • History of myocardial infarction within six months before the first dose of trial 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[1]related AEs (irAEs). • History of: Grade 2 immune mediated myocarditis/colitis/pneumonitis that led to CPI discontinuation. Patients experiencing other Grade 2 immune mediated AEs that led to CPI discontinuation, require discussion with the sponsor. Any Grade ≥3 immune mediated AEs that led to CPI discontinuation. − Patients with Grade 3 AEs 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 trial treatment. • Evidence of interstitial lung disease. • Ongoing pneumonitis or history of noninfectious pneumonitis that has required steroids. • 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 six weeks prior to C1D1. • Serious, non-healing wound, skin ulcer (of any grade), or bone fracture will be excluded
• Prior therapy: Radiotherapy within 14 days prior to first BNT314 administration. Palliative radiotherapy will be allowed, but not to target lesions. Any EpCAM- or 4-1BB-targeting treatment. Treatment with an anti-cancer agent within 4 weeks or for systemic therapies after at least 5 half-lives of the drug, whichever is shorter, prior to trial treatment administration. Patient has received any investigational agent or used an invasive investigational medical device within 28 days before the planned first dose of BNT314 or is currently enrolled in an interventional trial. Patient has a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone 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 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 two weeks prior to first BNT314 administration or is chronically transfusion dependent. Any positive test for hepatitis B, indicating acute or chronic infection. Any positive test for hepatitis C, indicating acute or chronic infection. Received any live vaccine within 30 days prior to the start of trial treatment.
• Known alcohol dependency within 6 months enrolment in this trial.
• Planned enrolment in another trial of an IMP, starting after Visit D1 and continuously until the last planned visit in this trial.
• Have a medical, psychological, or social condition which, in the opinion of the investigator, could compromise their wellbeing if they participate in the trial, 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 trial.