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

ID: NCT02581878
Status: Recruiting
Phase: Phase 1
Start Date: November 20, 2015
First Submitted: October 20, 2015
Last Updated: February 23, 2018
Results: N/A
Organization: Bayer
Sponsors & Collaborators: Bayer
Location: Sweden, United Kingdom
Conditions: Lymphoma, Non-Hodgkin
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Study Description

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)

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.
Condition or disease Intervention/treatment Phase

Lymphoma, Non-Hodgkin

Drug: BAY1862864
Other Names
Drug: BAY1862864
Other Names
Phase 1

Tracking Information

First Submitted DateOctober 20, 2015
Last Update Posted DateFebruary 23, 2018
Actual Start DateNovember 20, 2015
Anticipated Completion DateMarch 30, 2020
Actual Primary Completion DateMarch 30, 2020
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs) [Time Frame: Up to 12 weeks after first treatment]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

Not Available

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleSafety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
Official TitleAn 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
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)

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.

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
60
Allocation
Non-Randomized
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Treatment
Conditions
Lymphoma, Non-Hodgkin
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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 1.4 MBq and increase in steps of 1.4 MBq, with a protein dose of 2 or 10 mg.

Other Names
Drug: BAY1862864

Radiopharmaceutical, injection Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. The dose for this expansion part of the study will be selected on the basis of all available information from the dose-escalation part and will not necessarily be the MTD.

Other Names
Study Groups/Cohorts
Period 1
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma

Period 2
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma or patients with Relapsed or refractory Diffuse large B-cell lymphoma (R/R-DLBCL)

Study Arms
Experimental Period 1
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma
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 1.4 MBq and increase in steps of 1.4 MBq, with a protein dose of 2 or 10 mg.

Experimental Period 2
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma or patients with Relapsed or refractory Diffuse large B-cell lymphoma (R/R-DLBCL)
Drug : BAY1862864
Radiopharmaceutical, injection Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. The dose for this expansion part of the study will be selected on the basis of all available information from the dose-escalation part and will not necessarily be the MTD.

Arm Intervention/Treatment
Experimental Period 1
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma
Drug : BAY1862864
Experimental Period 2
Cancer patients with relapsed or refractory non-Hodgkin's lymphoma or patients with Relapsed or refractory Diffuse large B-cell lymphoma (R/R-DLBCL)
Drug : BAY1862864

Recruitment Information

Recruitment Status:Recruiting
Enrollment60
Completion DateMarch 30, 2020
Eligibility 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
- 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 virus surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab) and/or human immunodeficiency virus antibody (HIV-Ab) test
- Significant liver dysfunction, 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Sweden
United Kingdom
Austria
Finland
Germany

Administrative Information

NCT Number:NCT02581878
Other Study ID Numbers
17845
2014-004140-36
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Bayer
Collaborators
Not Available
Investigators
Study Director
Bayer Study Director
Bayer