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NCT Number: NCT03507452

First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With 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

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Key information

Conditions

Advanced Recurrent Malignant Pleural Epithelioid Mesothelioma Adenoma Advanced Pancreatic Ductal Adenocarcinoma (Optional, Dose Expansion, Not Initiated) Advanced Recurrent Malignant Peritoneal Epithelioid Mesothelioma Advanced Recurrent Serous Ovarian Cancer Lung Diseases Lung Neoplasms Mesothelioma Mesothelioma, Malignant Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Mesothelial Pleural Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

HUS, Meilahden sairaala, Helsinki, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BAY2287411

Drug

Dose Escalation part:

A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).

Primary outcomes

  1. Incidence of DLTs (dose-limiting toxicity)

    Time frame: 6 weeks (42 days)

  2. Proportion of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and serious adverse events (SAEs)

    Time frame: 6 months after the end of treatment

Secondary outcomes

  1. Cmax of Thorium-227 after single dose of Cycle 1

    Time frame: From Day 1 to 43

  2. Cmax of Radium-223 after single dose of Cycle 1

    Time frame: From Day 1 to 43

  3. Cmax of Total antibody after single dose of Cycle 1

    Time frame: From Day 1 to 43

  4. AUC(0-42 days) of Radium-223 after single dose of Cycle 1

    Time frame: From Day 1 to 43

  5. AUC(0-42 days) of Total antibody after single dose of Cycle 1

    Time frame: From Day 1 to 43

  6. AUC(0-42 days) of Thorium-227 after single dose of Cycle 1

    Time frame: From Day 1 to 43

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2022
First posted
Apr 25, 2018
Registry last updated
Mar 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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