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BAY1862864

Phase 1

Lymphoma, Non-Hodgkin | Small molecule | Oncology |Bayer AG|Last Updated: Nov 25, 2020

Success Probability

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

Clinical trial landscape

BAY1862864 · 1 trial · 1 indication

Phase 1 1
NCT02581878Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's LymphomaLymphoma, Non-Hodgkin
COMPLETED21 Analytics
PHASE1COMPLETED
Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma
Lymphoma, Non-HodgkinUnlock trial analytics

Study Endpoints

Primary Endpoints

Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)
Up to 6 weeks
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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 \[ACC\]).
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).
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).
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).
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).

Interventions

NameTypeDescription
BAY1862864DRUGRadiopharmaceutical, 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.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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 ...

Countries:SwedenUnited Kingdom
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Frequently asked questions about BAY1862864

What is BAY1862864 used for?

BAY1862864 is an investigational small molecule being studied for the treatment of relapsed or refractory CD22-positive Non-Hodgkin's lymphoma. It is administered as an injection and is currently in Phase 1 clinical development. The drug is not approved and remains under investigation for this oncology indication.

Who makes BAY1862864?

BAY1862864 is being developed by Bayer AG, a multinational pharmaceutical company. Bayer's stock is traded over-the-counter under the ticker symbol BAYRY. The company is conducting clinical research to evaluate the safety and tolerability of this investigational drug in patients with Non-Hodgkin's lymphoma.

What phase is BAY1862864 in?

BAY1862864 is in Phase 1 clinical development. A Phase 1 trial has been completed to assess its safety and tolerability in patients with relapsed or refractory CD22-positive Non-Hodgkin's lymphoma. The drug is investigational and has not received regulatory approval for any use.

What clinical trials is BAY1862864 in?

BAY1862864 has been studied in one completed Phase 1 clinical trial, identified as NCT02581878. This trial evaluated the safety and tolerability of BAY1862864 injection in 21 subjects with relapsed or refractory CD22-positive Non-Hodgkin's lymphoma. The study was conducted in Sweden and the United Kingdom.

Is BAY1862864 the same as any other drug?

No alternative names for BAY1862864 have been reported. The drug is identified solely by its code name BAY1862864 in clinical trial records. It is an investigational small molecule being developed by Bayer AG for the treatment of Non-Hodgkin's lymphoma.