An open-label, first-in-human, multi-center study to evaluate the safety, tolerability, pharmacokinetics and anti-tumor activity of a thorium-227 labeled antibody-chelator conjugate, BAY 2287411 Injection, in patients with solid tumors known to express mesotheli
- Conditions
- mesotheline expressie solide tumoren. (epithelioid mesothelioma, sereuze ovarium carcinoma, pancreas adenocarcinoma).mesothelin positive tumor cells in malignancies with multiple indications
- Registration Number
- NL-OMON50671
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 18
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:
- Impaired cardiac function or clinically significant cardiac disease
- Pericarditis (any CTCAE grade) or pericardial effusion (CTCAE Grade >= 2)
- Left Ventricular Ejection Fraction (LVEF) < 50% (as measured at screening by
echocardiogram).
- History of anaphylactic reactions to monoclonal antibody therapy
- History of Myelodysplastic syndrome (MDS)/treatment-related acute myeloid
leukemia (t-AML) or with features suggestive of MDS/AML
- Infections of CTCAE (Common Terminology Criteria for Adverse Events) version
5.0 Grade 2 not responding to therapy or active clinically serious infections
of CTCAE Grade >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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary study variable is the incidence of DLTs during the first 6 weeks of<br /><br>treatment (Cycle 1) following administration of BAY 2287411 Injection.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Cmax of Thorium-227 after single dose of Cycle 1<br /><br>- Cmax of Radium-223 after single dose of Cycle 1<br /><br>- Cmax of Total antibody after single dose of Cycle 1<br /><br>- AUC(0-42 days) of Radium-223 after single dose of Cycle 1<br /><br>- AUC(0-42 days) of Total antibody after single dose of Cycle 1<br /><br>- AUC(0-42 days) of Thorium-227 after single dose of Cycle 1 </p><br>