First-in-human Study of BAY2287411 Injection, a Thorium-227 Labeled Antibody-chelator Conjugate, in Patients With Tumors Known to Express Mesothelin
NCT ID: NCT03507452
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
36 participants
INTERVENTIONAL
2018-06-13
2022-03-29
Brief Summary
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* 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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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose escalation cohort a
Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options.
The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 mg.
BAY2287411
Dose Escalation part:
A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Dose escalation cohort b
Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options.
The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with a total antibody dose within the range of 10 - 50 mg.
BAY2287411
Dose Escalation part:
A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Dose Expansion Cohort 1
Subjects with advanced recurrent epithelioid mesothelioma or serous ovarian cancer, who have exhausted available therapeutic options
Dose / Regimen 1 (to be determined after completion of the dose escalation)
BAY2287411
Dose Expansion part:
The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
Dose Expansion Cohort 2
Subjects with advanced recurrent epithelioid mesothelioma or serous ovarian cancer, who have exhausted available therapeutic options
Dose / Regimen 2 (to be determined after completion of the dose escalation)
BAY2287411
Dose Expansion part:
The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
Dose expansion Cohort 3 (optional)
Subjects with histologically or cytologically confirmed unresectable, metastatic or locally advanced pancreatic ductal adenocarcinoma
Dose / Regimen to be determined
BAY2287411
Dose Expansion part:
The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
Dose escalation cohort c
Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options.
The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 - 150 mg mg.
BAY2287411
Dose Escalation part:
A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Dose escalation cohort d
Subjects with either advanced recurrent epithelioid mesothelioma or serous ovarian cancer who have exhausted available therapeutic options.
The dose of Thorium-227 will start at 1.5 MBq and increase in steps of 1.0 or 1.5 MBq, with antibody doses of 10 - 400 mg.
BAY2287411
Dose Escalation part:
A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
Interventions
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BAY2287411
Dose Escalation part:
A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days).
BAY2287411
Dose Expansion part:
The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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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
Countries
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References
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Roy J, Jagoda EM, Basuli F, Vasalatiy O, Phelps TE, Wong K, Ton AT, Hagemann UB, Cuthbertson AS, Cole PE, Hassan R, Choyke PL, Lin FI. In Vitro and In Vivo Comparison of 3,2-HOPO Versus Deferoxamine-Based Chelation of Zirconium-89 to the Antimesothelin Antibody Anetumab. Cancer Biother Radiopharm. 2021 May;36(4):316-325. doi: 10.1089/cbr.2020.4492.
Hagemann UB, Ellingsen C, Schuhmacher J, Kristian A, Mobergslien A, Cruciani V, Wickstroem K, Schatz CA, Kneip C, Golfier S, Smeets R, Uran S, Hennekes H, Karlsson J, Bjerke RM, Ryan OB, Mumberg D, Ziegelbauer K, Cuthbertson AS. Mesothelin-Targeted Thorium-227 Conjugate (MSLN-TTC): Preclinical Evaluation of a New Targeted Alpha Therapy for Mesothelin-Positive Cancers. Clin Cancer Res. 2019 Aug 1;25(15):4723-4734. doi: 10.1158/1078-0432.CCR-18-3476. Epub 2019 May 7.
Related Links
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Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.
Other Identifiers
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2017-004052-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
18795
Identifier Type: -
Identifier Source: org_study_id
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