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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 | Clinical Trials | Clareo Health

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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

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

NCT03507452•Bayer

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (7)

National Cancer Institute - Maryland

Bethesda, Maryland, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

HUS, Meilahden sairaala

Helsinki, Finland

Nederlands Kanker Instituut

Amsterdam, Netherlands

Universitair Medisch Centrum Groningen

Groningen, Netherlands

Skånes Universitetssjukhus

Lund, Sweden

Royal Marsden NHS Trust (Surrey)

Sutton, Surrey, United Kingdom

Key Dates

Start Date

June 13, 2018

Primary Completion Date

September 29, 2021

Completion Date

March 29, 2022

Last Updated

March 20, 2023

Enrollment

ACTUAL participants

Conditions

Advanced Recurrent Malignant Pleural Epithelioid MesotheliomaAdvanced Recurrent Malignant Peritoneal Epithelioid MesotheliomaAdvanced Recurrent Serous Ovarian CancerAdvanced Pancreatic Ductal Adenocarcinoma (Optional, Dose Expansion, Not Initiated)

Interventions

BAY2287411

DRUG

BAY2287411

DRUG