Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BAY1862864 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1a | EXPERIMENTAL | 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 \[ACC\]). |
| Cohort 1b | EXPERIMENTAL | 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). |
| Cohort 2 | EXPERIMENTAL | 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). |
| Cohort 3 | EXPERIMENTAL | 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). |
| Cohort 4 | EXPERIMENTAL | 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). |
| Name | Type | Description |
|---|---|---|
| BAY1862864 | DRUG | 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. |
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 ...
BAY1862864 is an investigational therapy being studied for relapsed or refractory CD22-positive non-Hodgkin lymphoma. It is a small molecule developed by Bayer AG. The Phase 1 trial evaluated its safety and tolerability in this patient population. It is not yet approved for any indication.
BAY1862864 is being developed by Bayer AG, which trades on the OTC market under the ticker BAYRY. Bayer is the sponsor of the clinical program investigating this small molecule in CD22-positive non-Hodgkin lymphoma.
BAY1862864 is in Phase 1 clinical development. The single Phase 1 trial, NCT02581878, has been completed. The study enrolled 21 participants and assessed safety and tolerability in patients with relapsed or refractory CD22-positive non-Hodgkin lymphoma.
BAY1862864 has been evaluated in one Phase 1 clinical trial, NCT02581878, titled "Safety and Tolerability of BAY1862864 Injection in Subjects With Relapsed or Refractory CD22-positive Non-Hodgkin's Lymphoma." The trial was completed and enrolled 21 participants across Sweden and the United Kingdom.
BAY1862864 is not FDA approved. It is an investigational small molecule in Phase 1 clinical development for relapsed or refractory CD22-positive non-Hodgkin lymphoma. The only trial, NCT02581878, has been completed, but no regulatory approval has been granted.