Safety and preliminary efficacy of BNT314 with or without an immune checkpoint inhibitor in cancer patients with malignant solid tumors
- Conditions
- Advanced or metastatic malignant solid tumorsMedDRA version: 20.0Level: LLTClassification code: 10025648Term: Malignant mast cell tumors unspecified site extranodal and solid organ sites Class: 10029104Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2023-506053-38-00
- Lead Sponsor
- BioNTech SE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 243
Have the ability to voluntarily give informed consent by signing and dating the informed consent form (ICF) before initiation of any trial-specific procedures., Have adequate renal function at screening as determined by: Glomerular filtration rate (GFR) =45 mL/min/1.73 m² according to the abbreviated Modification of Diet in Renal Disease equation., Have adequate pancreas function at screening as determined by serum amylase and lipase with no signs and symptoms of pancreatitis., Patients of childbearing potential (POCBP) must have a negative urine and serum beta human chorionic gonadotropin (beta-hCG) test at screening., POCBP must agree to practice a highly effective form of contraception and to require their male partners to use condoms with a spermicidal agent, starting at Visit D1 and thereafter until 60 days after receiving the last trial treatment., POCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting at Visit D1 and thereafter until 60 d after receiving the last trial treatment., Men who are sexually active and have not had a bilateral vasectomy or orchidectomy must agree to use condoms with a spermicidal agent and to require their female partners to practice a highly effective form of contraception during the trial, starting at Visit D1 and thereafter until 90 d after receiving the last trial treatment., Men must be willing to refrain from sperm donation, starting at Visit D1 and thereafter until 90 days (one sperm cycle) after receiving the last trial treatment., Inclusion criteria for monotherapy dose escalation only: 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., Inclusion criteria for backfill cohorts only: Patients with previously documented metastatic or advanced malignant solid tumor of selected cancers who have received at least one prior therapy for locally advanced/unresectable and/or metastatic disease., Inclusion criteria for combination therapy SRI and dose expansion only. For patients in Expansion Cohort 1: Patients with histologically confirmed locally advanced/unresectable and/or metastatic selected cancer. With documented PD on or after standard therapy., 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., For patients in Expansion Cohort 2: Patients with locally advanced/unresectable and/or metastatic selected cancer., For patients in Expansion Cohort 3: Patients with locally advanced/unresectable and/or metastatic selected cancer. Neoadjuvant/adjuvant therapy will not qualify as required prior treatment line., For patients in Expansion Cohort 4: Patients with locally advanced/unresectable and/or metastatic selected cancer., For patients in Expansion Cohort 5: Patients with locally advanced/unresectable and/or metastatic selected cancer. Tumor must express PD-L1 assessed as part of the patient’s prior treatment., 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 ECOG performance score of 0 or 1 at screening., Have adequate coagulation function at screening as determined by: International normalized ratio
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. Patie
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method