Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With R/R B-NHL
Status:
Recruiting
Trial end date:
2024-12-30
Target enrollment:
Participant gender:
Summary
The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab
in Japanese patients with relapsed, progressive or refractory B-cell lymphomas and Japanese
patients with B-cell lymphomas that have achieved partial response (PR) or complete response
(CR) following prior SOC. The trial consists of two parts: Part 1, dose escalation (phase 1),
and Part 2, expansion (phase 2).
The purpose of the dose-escalation part of the trial is to determine the maximum tolerated
dose (MTD) and the recommended Phase-2 dose (RP2D), as well as to establish the safety
profile of epcoritamab in Japanese patients with relapsed, progressive or refractory B-cell
lymphoma and Japanese patients with B-cell lymphomas that have achieved partial response (PR)
or complete response (CR).
In the expansion part, additional patients will be treated with epcoritamab, at the RP2D and
the purpose is to further explore and determine the safety and efficacy of epcoritamab.
Part 2 of the trial will be initiated once the RP2D has been determined in Part 1. In Part 2,
epcoritamab is investigated as a monotherapy and in combination with other standard of care
(SOC) agents.