Phase 1b/2, Open-Label Study to Evaluate Safety and Tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma

AbbVie Deutschland GmbH & Co. KG38 sites in 7 countries59 target enrollmentFebruary 5, 2024

Overview

Phase: Phase 1/2
Intervention: Not specified
Conditions: Not specified
Sponsor: AbbVie Deutschland GmbH & Co. KG
Enrollment: 59
Locations: 38
Primary Endpoint: The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.
Status: Recruiting
Last Updated: 10 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The primary objectives of the study are to characterize the safety, toxicity and tolerability profiles of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL and to determine the recommended dose for further investigation of epcoritamab when co-administered with anti-neoplastic agents in subjects with B-cell NHL.

Registry

euclinicaltrials.eu

Start Date

February 5, 2024

End Date

TBD

Last Updated

10 months ago

Investigators

Sponsor

AbbVie Deutschland GmbH & Co. KG

Responsible Party

Principal Investigator

Global Clinial Trial Helpdesk

Scientific

AbbVie Deutschland GmbH & Co. KG

Eligibility Criteria

Inclusion Criteria

•Adult male or female, at least 18 years old
•(Arms 1, 2, 3, and 4) Diagnosis of DLBCL (de novo or histologically transformed from follicular lymphoma or nodal marginal zone lymphoma) with histologically confirmed CD20+ disease, inclusive of the following according to WHO 2016 classification and documented in pathology report: DLBCL, not otherwise specified (NOS) - High-grade B cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations per World Health Organization (WHO) 2016 ("double-hit" or "triple-hit") Note: High-grade B-cell lymphomas NOS or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) are not eligible - FL Grade 3B OR FL with histologically confirmed CD20+ Grade 1 to 3a and no evidence of histologic transformation to an aggressive lymphoma at most recent representative tumor biopsy, according to WHO 2016 classification. OR MCL with histologically confirmed CD20+ disease at most recent representative tumor biopsy according to the WHO 2016 classification with evidence of overexpression of cyclin D1 in association with relevant markers or evidence of t(11;14) assessed by flow cytometry, FISH, or PCR
•Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2, except for Arms 6, 7 and 8where ECOG performance status must be 0-1
•Subject must have 1 or more measurable disease sites: A positron emission tomography/computed tomography (PET/CT) scan demonstrating PET-positive lesion(s) AND - At least 1 measurable nodal lesion (long axis > 1.5 cm) or ≥ 1 measurable extra-nodal lesion (long axis > 1.0 cm) on CT scan or MRI

Exclusion Criteria

•Diagnosis of High-grade B-cell lymphomas NOS or other double- /triple-hit lymphomas (with histologies not consistent with DLBCL)
•Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20

Outcomes

Primary Outcomes

The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.

Secondary Outcomes

Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents.
Antilymphoma activity of epcoritamab in combination with other antineoplastic agents: - Duration of response determined per Lugano 2014 criteria as assessed by investigator. - Progression free survival determined per Lugano 2014 criteria as assessed by investigator. - Complete response during the study determined per Lugano 2014 criteria as assessed by investigator. - Time to response determined per Lugano 2014 criteria as assessed by investigator. - Time to next antilymphoma therapy.