mesotheline expressie solide tumoren. (epithelioid mesothelioma, sereuze ovarium carcinoma, pancreas adenocarcinoma). mesothelin positive tumor cells in malignancies with multiple indications
Conditions
Interventions
BAY 2287411 Injection will be administered intravenously on Day 1 of each cycle
lasting 6 weeks (42 days). Subjects will receive a starting dose of thorium-227
of 1.5 MBq with antibody doses within
Sponsors
Bayer
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Inclusion Criteria: - Signed informed consent - Male or female subjects >= 18 years of age - ECOG (Eastern Cooperative Oncology Group) PS of 0 or 1 - Patients with advanced malignant epithelioid mesothelioma or advanced recurrent serous ovarian cancer, who have exhausted available therapeutic options; in addition, in the dose expansion part of the study, patients with metastatic pancreatic adenocarcinoma, who have exhausted available therapeutic options - Availability of fresh or archival tumor samples - Adequate bone marrow, liver, and renal function, as assessed by the following laboratory requirements (within 28 days before start of study drug treatment) - Negative serum pregnancy test in women of childbearing potential (WOCBP) performed within 7 days before the start of study drug administration. Women and men of reproductive potential must agree to use highly effective methods of contraception, when sexually active.
Exclusion criteria
Exclusion criteria: Exclusion Criteria: - Impaired cardiac function or clinically significant cardiac disease - Pericarditis (any CTCAE grade) or pericardial effusion (CTCAE Grade >= 2) - Left Ventricular Ejection Fraction (LVEF) 2; known human immunodeficiency virus (HIV) infection; active hepatitis B virus (HBV) or hepatitis C virus (HCV)infection requiring treatment. Patients with chronic HBV or HCV infection are eligible at the investigator*s discretion provided that the disease is stable and sufficiently controlled under treatment - Known brain, spinal or meningeal metastases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary study variable is the incidence of DLTs during the first 6 weeks of treatment (Cycle 1) following administration of BAY 2287411 Injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Cmax of Thorium-227 after single dose of Cycle 1 - Cmax of Radium-223 after single dose of Cycle 1 - Cmax of Total antibody after single dose of Cycle 1 - AUC(0-42 days) of Radium-223 after single dose of Cycle 1 - AUC(0-42 days) of Total antibody after single dose of Cycle 1 - AUC(0-42 days) of Thorium-227 after single dose of Cycle 1 | — |
Countries
Netherlands
Outcome results
None listed