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Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02581878
Recruitment Status : Completed
First Posted : October 21, 2015
Last Update Posted : November 25, 2020
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
To establish a recommended dose of BAY1862864 Injection and to investigate how the study drug acts in the body, on the cancer cells and how safe it is in patients with advanced non-Hodgkin's lymphoma (NHL)

Condition or disease Intervention/treatment Phase
Lymphoma, Non-Hodgkin Drug: BAY1862864 Phase 1

Detailed Description:
The study will be divided into two parts: a "dose-escalation part" to evaluate safety profile and to explore the Maximum tolerated dose (MTD) and an "expansion part" to evaluate further the safety and tumor response profile of BAY1862864 Injection at the selected dose.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Phase I, Dose-escalation Study to Evaluate the Safety, Tolerability, Maximum Tolerated Dose, Biodistribution, Radiation Dosimetry and Pharmacokinetics of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
Actual Study Start Date : November 20, 2015
Actual Primary Completion Date : November 11, 2019
Actual Study Completion Date : November 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Cohort 1a
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (2 mg antibody chelator conjugate [ACC]).
Drug: BAY1862864
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Experimental: Cohort 1b
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 1.5 MBq (10 mg ACC).
Drug: BAY1862864
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Experimental: Cohort 2
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 3.1 MBq (10 mg ACC).
Drug: BAY1862864
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Experimental: Cohort 3
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 4.6 MBq (10 mg ACC).
Drug: BAY1862864
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.

Experimental: Cohort 4
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma will be randomized to receive an injection of study drug (BAY1862864) with a dosage of 6.1 MBq (10 mg ACC).
Drug: BAY1862864
Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.




Primary Outcome Measures :
  1. Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs) [ Time Frame: Up to 6 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has relapsed or refractory CD22-positive histologically confirmed NHL
  • An archival paraffin-embedded tissue or fresh biopsy is available for the retrospective quantitative assessment of CD22 levels
  • Bone marrow involvement of cellular marrow with lymphoma determined to be < 25%
  • Subject has failed at least one prior chemo-/immunotherapy-based regimen
  • Life expectancy of at least 12 weeks
  • Not eligible for, or refused, or failed high-dose therapy combined with autologous stem cell rescue (HDT ASCR)
  • Eastern Cooperative Oncology Group (ECOG) performance status of ≤2
  • Women of childbearing potential must have negative pregnancy test within seven days before the start of treatment
  • Subject was using adequate barrier birth control measures before the study and is willing to continue use of these during the entire course of the study and for the twelve months after the last administration of BAY1862864 Injection
  • Adequate bone-marrow, hepatic and renal function
  • Subject is capable of giving informed consent and has provided such consent in writing

Exclusion Criteria:

  • Previous exposure to the study drug. Previous exposure to CD22 antibody within six months before screening. Any radio-immunotherapy within six months before screening.
  • History of anaphylactic reactions to monoclonal antibody therapy. Known or suspected allergy or intolerance to any agent to be given in the course of this study.
  • Anti-cancer immunotherapy and/or anti cancer chemotherapy within four weeks before the first dose of study drug
  • Previous therapy with fludarabine-containing regimens within three months before screening
  • Participation in any other clinical trial in which the subject received active therapy within four weeks before the first scheduled dose of study drug
  • Any toxic effects (CTCAE ≥ Grade 2) of previous anti cancer therapy (incl. radiotherapy) that have not yet stabilized or significant post-treatment toxicities have been observed
  • Prior definitive radiotherapy completed less than four weeks before the date scheduled for first dose of BAY1862864
  • History of symptomatic metastatic brain or meningeal tumors. Presence of new or progressive brain metastases.
  • History of clinically significant cardiac disease
  • Clinically relevant findings in the ECG.
  • Uncontrolled hypertension, defined as systolic blood pressure > 160 mmHg and / or diastolic blood pressure > 100 mmHg, despite optimum medical management
  • History of arterial or venous thrombotic or embolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, or clinically relevant pulmonary embolism within three months before the first administration of BAY1862864 (except for adequately treated catheter-related venous thrombosis occurring more than one month before start of study medication)
  • Autologous bone-marrow transplant or stem-cell rescue within three months before the first administration of BAY1862864
  • Organ allograft (except for corneal transplant) or allogeneic bone-marrow transplant at any time before the first administration of BAY1862864
  • Positive result of hepatitis B virus (HBV-DNA) and/or human immunodeficiency virus antibody (HIV-Ab) test
  • Liver cirrhosis, defined as Child-Pugh class B or C
  • Any active infection of CTCAE Grade ≥2
  • Previous or concurrent cancer that is distinct in primary site or histology from the cancer being evaluated in this study
  • Major surgery or significant trauma within four weeks before the first administration of BAY1862864
  • Any treatment with biological response modifiers (such as, but not limited to, granulocyte colony-stimulating factor, G CSF), or any blood transfusion, within three weeks before first administration of BAY1862864
  • Substance abuse, medical, psychological or social conditions that may interfere with the subject's participation in the study or evaluation of the study result
  • Current pregnancy or breast-feeding
  • Any condition that is unstable or could jeopardize the safety of the subject and his/her compliance with study requirements
  • Close affiliation with the investigation site
  • Any use by the subject of illicit drugs or other substances that may, in the opinion of the investigator or his/her designated associate(s), have a reasonable chance of contributing to toxicity or otherwise confound the results

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02581878


Locations
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Sweden
Skanes Universitetssjukhus
Lund, Sweden, 221 85
United Kingdom
Southampton General Hospital
Southampton, Hampshire, United Kingdom, SO16 6YD
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom, SM2 5PT
Royal Free Hospital
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02581878    
Other Study ID Numbers: 17845
2014-004140-36 ( EudraCT Number )
First Posted: October 21, 2015    Key Record Dates
Last Update Posted: November 25, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Thorium-227
BAY1862864 Injection
Safety
Pharmacokinetics
CD22
Radioimmunotherapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases