Clinical Trials /

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

NCT02581878

Description:

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)

Related Conditions:
  • Non-Hodgkin Lymphoma
Recruiting Status:

Completed

Phase:

Phase 1

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: 17845
  • SECONDARY ID: 2014-004140-36
  • NCT ID: NCT02581878

Conditions

  • Lymphoma, Non-Hodgkin

Interventions

DrugSynonymsArms
BAY1862864Cohort 1a

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Cohort 1aExperimentalCancer 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]).
  • BAY1862864
Cohort 1bExperimentalCancer 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).
  • BAY1862864
Cohort 2ExperimentalCancer 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).
  • BAY1862864
Cohort 3ExperimentalCancer 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).
  • BAY1862864
Cohort 4ExperimentalCancer 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).
  • BAY1862864

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 (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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)
Time Frame:Up to 6 weeks
Safety Issue:
Description:

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Completed
Lead Sponsor:Bayer

Trial Keywords

  • Thorium-227
  • BAY1862864 Injection
  • Safety
  • Pharmacokinetics
  • CD22
  • Radioimmunotherapy

Last Updated

November 25, 2020