Clinical trial: First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin (NCT03507452)

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

          -  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 tissue samples

          -  Adequate bone marrow, liver and renal function, as assessed by pre-defined laboratory
             requirements (within 28 days before start of study drug treatment)

          -  A 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, clinically significant cardiac disease or cardiac
             arrhythmias

          -  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
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 61-year-old man comes to the clinic due to nonproductive cough and progressive dyspnea.  The patient's medical conditions include hypertension, hypercholesteremia and peptic ulcer disease.  He smokes 2 packs of cigarettes daily for the past 30 years.  On examination, there are decreased breath sounds and percussive dullness at the base of the left lung.  Other vital signs are normal. Abdomen is soft without tenderness. CT scan shows a left-sided pleural effusion and nodular thickening of the pleura. The plural fluid was bloody on thoracentesis. Biopsy shows proliferation of epithelioid-type cells with very long microvilli.

Patient description (patient's own words): I am 61 and I had to go to the clinic because I couldn't stop coughing and I experienced some breath shortness. I suffer from hypertension and cholesterol and I also have a stomach ulcer. I should admit that I've been smoking 2 packs of cigarettes every day for the past 30 years. My doctor told me that my breath in my left lung sounds bad. But he told me that my blood pressure, heart rate, breathing rate and temperature are normal. My belly is also normal. However my X-Rays show some liquid on the left side and a mass where the liquid got hard. The scary thing is that the liquid was bloody when they got it out. They did a biopsy and it showed that I have an increase of epithelioid-type cells with very long microvilli.

Does the patient match the trial criteria? Entailment