First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin

April 26, 2018

Primary Outcome Measures

Incidence of DLTs (dose-limiting toxicity) [ Time Frame: 6 weeks (42 days) ]

Eligibility

Inclusion Criteria: Signed informed consent; Male or female subjects ≥ 18 years of age; ECOG PS (Eastern Cooperative Oncology Group Performance Status) of 0 or 1; Subjects with advanced, histologically or cytologically confirmed epithelioid mesothelioma (pleural or peritoneal) or serous ovarian cancer, not responsive to standard therapy or lacking appropriate treatment 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

Exclusion Criteria: Impaired cardiac function or clinically significant cardiac disease; Any clinically significant pericardial effusion; Subjects known to be affected by genetic defects linked to radiation hypersensitivity; Infections of CTCAE (Common Terminology Criteria for Adverse Events) version 4.03 Grade 2 not responding to therapy or active clinically serious infections of CTCAE Grade >2 will be excluded; History of anaphylactic reactions to monoclonal antibody therapy; Myelodysplastic syndrome (MDS)/treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML

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