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

• Status: Active, not recruiting
• Trial end date: 2022-03-21
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Antibodies; BAY 2287411; Chelating Agents; Immunoglobulins

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