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

Published: April 26, 2018

Primary Outcome Measures

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


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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