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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

Brief Summary

The primary objective of this study is, to determine the safety, tolerability, maximum tolerated dose (MTD) or maximum feasible dose of BAY2287411 Injection in patients with epithelioid malignant mesothelioma and serous ovarian cancer

Tracking Information
First Received DateApril 16, 2018
Last Changed DateAugust 10, 2018
Start DateJune 13, 2018
Anticipated Primary Completion DateDecember 1, 2020
Primary Outcome Measures

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

Descriptive Information
PhasePhase 1
Study TypeInterventional
Condition
  • Mesothelioma, Ovarian Neoplasms
Intervention
  • Drug: BAY2287411 Injection
Study Arms / Comparison Groups1 / 0
Recruitment Information
Recruitment StatusRecruiting
Anticipated Enrollment42
GenderAll
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Contact Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayer.com
Phone: (+) 1-888-8422937
Eligibility Criteria

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

Administrative Information
NCTIDNCT03507452
Responsible PartySponsor
SponsorBayer
Verification DateAugust 2018
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