check_circleStudy Completed

Advanced recurrent malignant pleural epithelioid mesothelioma, Advanced recurrent malignant peritoneal epithelioid mesothelioma, Advanced recurrent serous ovarian cancer, Advanced pancreatic ductal adenocarcinoma (optional, dose expansion, not initiated)

Bayer Identifier:

18795

ClinicalTrials.gov Identifier:

NCT03507452

EudraCT Number:

2017-004052-29

EU CT Number:

Not Available
First-in-human study of BAY2287411 Injection, a thorium-227 labeled antibody-chelator conjugate, in patients with tumors known to express mesothelin

Trial purpose

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

Key Participants Requirements

Sex

All

Age

18 - N/A
  • - 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.
  • - 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

Trial summary

Enrollment Goal
36
Trial Dates
June 2018 - March 2022
Phase
Phase 1
Could I Receive a placebo
No
Products
BAY2287411
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Skånes UniversitetssjukhusLund, 221 85, Sweden
Completed
Universitair Medisch Centrum GroningenGRONINGEN, 9713 GZ, Netherlands
Completed
Nederlands Kanker InstituutAMSTERDAM, 1066 CX, Netherlands
Completed
National Cancer Institute - MarylandBethesda, 20892, United States
Completed
HUS, Meilahden sairaalaHelsinki, 00290, Finland
Completed
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Withdrawn
Erasmus Medisch CentrumROTTERDAM, 3015 GD, Netherlands

Primary Outcome

  • Incidence of DLTs (dose-limiting toxicity)
    date_rangeTime Frame:
    6 weeks (42 days)
  • Proportion of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and serious adverse events (SAEs)
    date_rangeTime Frame:
    6 months after the end of treatment

Secondary Outcome

  • Cmax of Thorium-227 after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43
  • Cmax of Radium-223 after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43
  • Cmax of Total antibody after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43
  • AUC(0-42 days) of Radium-223 after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43
  • AUC(0-42 days) of Total antibody after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43
  • AUC(0-42 days) of Thorium-227 after single dose of Cycle 1
    date_rangeTime Frame:
    From Day 1 to 43

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
Non-randomized
Blinding
N/A
Assignment
Sequential Assignment
Trial Arms
7

Additional Information

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