First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin
| Status: | Recruiting |
|---|---|
| Conditions: | Lung Cancer, Ovarian Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | June 13, 2018 |
| End Date: | February 20, 2023 |
| Contact: | Bayer Clinical Trials Contact |
| Email: | clinical-trials-contact@bayer.com |
| Phone: | (+) 1-888-8422937 |
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, BAY2287411 Injection, in Patients With Solid Tumors Known to Express Mesothelin
The purpose of this study is to evaluate, in patients with tumors known to express the
protein mesothelin, the following properties of BAY2287411 injection:
- safety (to identify, assess, minimize, and appropriately manage the risks associated to
the study drug)
- tolerability (the degree to which side effects can be tolerated by your body)
- maximum tolerated dose
- pharmacokinetics (the effect of your body on the study drug)
- anti-tumor activity
- recommended dose for further clinical development
protein mesothelin, the following properties of BAY2287411 injection:
- safety (to identify, assess, minimize, and appropriately manage the risks associated to
the study drug)
- tolerability (the degree to which side effects can be tolerated by your body)
- maximum tolerated dose
- pharmacokinetics (the effect of your body on the study drug)
- anti-tumor activity
- recommended dose for further clinical development
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
We found this trial at
2
sites
Click here to add this to my saved trials
