This study is to evaluate the safety and tolerability of Epcoritamab in Combination with Anti-Neoplastic Agents in Subjects with Non-Hodgkin Lymphoma

Phase 1

Recruiting

• Conditions: B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma; MedDRA version: 20.0Level: HLGTClassification code: 10025320Term: Lymphomas non-Hodgkin's B-cell Class: 10029104; MedDRA version: 21.0Level: PTClassification code: 10003903Term: B-cell lymphoma refractory Class: 100000004864; MedDRA version: 21.0Level: PTClassification code: 10012822Term: Diffuse large B-cell lymphoma refractory Class: 100000004864; Therapeutic area: Diseases [C] - Neoplasms [C04]

• Registration Number: CTIS2023-505347-38-00
• Lead Sponsor: AbbVie Deutschland GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-30
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 87

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 and 7 where 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: To evaluate the anti-NHL activity of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL., To characterize the pharmacokinetics of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL.;Primary end point(s): The primary endpoint is DLTs of epcoritamab in combination with antineoplastic agents.

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Best overall response (BOR) by Lugano 2014 criteria as assessed by investigator for epcoritamab in combination with other antineoplastic agents.;Secondary end point(s):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.