Trial Condition(s):
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)
First-in-human study of BAY2287411 Injection, a thorium-227 labeled antibody-chelator conjugate, in patients with tumors known to express mesothelin
Bayer Identifier:
18795
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Royal Marsden NHS Trust (Surrey) Sutton, United Kingdom, SM2 5PT | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Skånes Universitetssjukhus Lund, Sweden, 221 85 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Universitair Medisch Centrum Groningen GRONINGEN, Netherlands, 9713 GZ | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations Nederlands Kanker Instituut AMSTERDAM, Netherlands, 1066 CX | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations National Cancer Institute - Maryland Bethesda, United States, 20892 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations HUS, Meilahden sairaala Helsinki, Finland, 00290 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Locations University of Texas MD Anderson Cancer Center Houston, United States, 77030 | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
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
Primary Outcome
- Incidence of DLTs (dose-limiting toxicity)Timeframe: 6 weeks (42 days)
- Proportion of participants with treatment-emergent adverse events (TEAEs), drug-related adverse events (AEs), and serious adverse events (SAEs)Timeframe: 6 months after the end of treatment
Secondary Outcome
- Cmax of Thorium-227 after single dose of Cycle 1Timeframe: From Day 1 to 43
- Cmax of Radium-223 after single dose of Cycle 1Timeframe: From Day 1 to 43
- Cmax of Total antibody after single dose of Cycle 1Timeframe: From Day 1 to 43
- AUC(0-42 days) of Radium-223 after single dose of Cycle 1Timeframe: From Day 1 to 43
- AUC(0-42 days) of Total antibody after single dose of Cycle 1Timeframe: From Day 1 to 43
- AUC(0-42 days) of Thorium-227 after single dose of Cycle 1Timeframe: From Day 1 to 43
Additional Information
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