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)
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
21
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.
Skanes Universitetssjukhus
Lund, Sweden
Southampton General Hospital
Southampton, Hampshire, United Kingdom
Royal Marsden NHS Trust (Surrey)
Sutton, Surrey, United Kingdom
Royal Free Hospital
London, United Kingdom
Maximum tolerated dose assessed by the number of subjects with dose-limiting toxicities (DLTs)
Time frame: Up to 6 weeks
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