Solid tumor
Conditions
Interventions
BNT314 Monotherapy
Sponsors
Nakano Masayuki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures. 2. Are willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions, and other requirements of the trial. This includes that they are able to understand and follow trial-related instructions. 3. Are >=18 years of age at the time of giving informed consent. 4. Have measurable disease according to RECIST v1.1. NOTE: Patients that present with no other measurable lesions apart from the ones that received external beam radiation therapy or locoregional therapy, must show radiographic evidence of subsequent growth of these lesions. 5. Have a life expectancy of >3 months. 6. Have ECOG PS score of 0 or 1 at screening. 7. Have adequate coagulation function at screening as determined by: - International normalized ratio (INR) or prothrombin time =1.5 * 109/L (>=1500/uL) (patients may not use granulocyte colony-stimulating factor or granulocyte-macrophage colony-stimulating factor to achieve these ANC levels in the past 7 d). - Platelet count >=100 * 109/L (>=100,000/uL). - Hemoglobin >=9 g/dL. - Any blood transfusions 1.5 * ULN. Exception for patients in monotherapy: Patients with Gilbert's syndrome must have a Tbili =30 g/L. 10. Have adequate renal function at screening as determined by: - Glomerular filtration rate (GFR) >=45 mL/min/1.73 m^2 according to the abbreviated Modification of Diet in Renal Disease equation. 11. Have adequate pancreas function at screening as determined by amylase and lipase with no signs and symptoms of pancreatitis. If required, contact the trial Medical Monitor for guidance. 12. Patients of childbearing potential (POCBP) must have a negative urine or blood beta human chorionic gonadotropin (beta-hCG) 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. 13. 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 d after receiving the last trial treatment. 14. POCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit D1 and thereafter until 120 d after receiving the last trial treatment. 15. 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 co
Exclusion criteria
Exclusion criteria: Exclusion Criteria: 1. 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 trial treatment. - History of myocardial infarction within 6 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 immunerelated 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. - 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 C1D1. - 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 trial (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 posi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of dose-limiting toxicity (DLTs) within a cohort during the DLT evaluation period Number and proportion of patients with occurrence of treatment-emergent adverse events (TEAEs) including Grade >= 3, serious, fatal TEAE by relationship Number and proportion of patients with occurrence of dose reduction and discontinuation of investigational medicinal product (IMP) due to TEAE Number and proportion of patients with occurrence of Grade >= 3 abnormal safety laboratory parameters | — |
Countries
Japan, UK, USA
Contacts
Public ContactjRCT Inquiry Contact IQVIA Services Japan G.K.
IQVIA Services Japan G.K.
Outcome results
None listed