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

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 - Non-Hodgkin Lymphoma: Epcoritamab in Combination with Anti-Neoplastic Agents

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-005725-24-ES

Enrollment

132

Registered

2022-03-04

Start date

2022-04-25

Completion date

Unknown

Last updated

2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Non-Hodgkin's lymphoma, diffuse large B-cell lymphoma MedDRA version: 21.0 Level: PT Classification code 10003903 Term: B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: PT Classification code 10012822 Term: Diffuse large B-cell lymphoma refractory System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 20.0 Level: HLGT Class

Interventions

Product Name: Epcoritamab Product Code: ABBV-GMAB-3013 Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Epcoritamab CAS Number: 2134641-34-0 Current Sponsor code: ABBV-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adult male or female, at least 18 years old 2. 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 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 • Follicular lymphoma Grade 3B 3. Subject must have Eastern Cooperative Oncology Group (ECOG) performance status 0 – 2 4. 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 = 1.5cm and short axis > 1.0 cm) or = 1 measurable extra-nodal lesion (long axis = 1.0 cm) on CT scan or MRI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 48 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 84

Exclusion criteria

Exclusion criteria: 1.Diagnosis of High-grade B-cell lymphomas NOs or other double-/triple-hit lymphomas (with histologies not consistent with DLBCL) 2. Subjects who have had prior treatment with epcoritamab or any other bispecific antibody targeting CD3 and CD20

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objectives of the study are to characterize the safety and toxicity 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: The secondary objective of the study is to evaluate the anti-NHL activity of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL and 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 dose limiting toxicities (DLTs) of epcoritamab in combination with anti-neoplastic agents.;Timepoint(s) of evaluation of this end point: Dose limiting toxicities (DLTs) will be assessed during each dose-escalation cohort. For this study, the DLT evaluation period is defined as the first four weeks, i.e., 28 days after the first administration of epcoritamab. After all subjects on a dose level have completed the DLT evaluation period, all available data (including observations occurring beyond the DLT evaluation period) will be evaluated to make a recommendation for the next dose level.	—

Measure

Time frame

Main Objective: The primary objectives of the study are to characterize the safety and toxicity 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: The secondary objective of the study is to evaluate the anti-NHL activity of epcoritamab when given in combination with anti-neoplastic agents in subjects with B-cell NHL and 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 dose limiting toxicities (DLTs) of epcoritamab in combination with anti-neoplastic agents.;Timepoint(s) of evaluation of this end point: Dose limiting toxicities (DLTs) will be assessed during each dose-escalation cohort. For this study, the DLT evaluation period is defined as the first four weeks, i.e., 28 days after the first administration of epcoritamab. After all subjects on a dose level have completed the DLT evaluation period, all available data (including observations occurring beyond the DLT evaluation period) will be evaluated to make a recommendation for the next dose level.

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Secondary

Measure	Time frame
Secondary end point(s): • Overall Response Rate (ORR) by Lugano 2014 criteria (Appendix E) as assessed by investigator for epcoritamab in combination with other anti-neoplastic agents. • Anti-lymphoma activity of epcoritamab in combination with other anti-neoplastic agents: -Duration of response (DOR) determined per Lugano 2014 criteria as assessed by investigator -Progression free survival (PFS) determined per Lugano 2014 criteria as assessed by investigator -Complete Response (CR) rate determined per Lugano 2014 criteria as assessed by investigator -Time to response (TTR) determined per Lugano 2014 criteria as assessed by investigator -Time to next anti-lymphoma therapy (TTNT) -Rate and duration of Minimal Residual Disease (MRD) negativity -Overall survival (OS);Timepoint(s) of evaluation of this end point: These will be assessed throughout the study.	—

Measure

Time frame

Secondary end point(s): • Overall Response Rate (ORR) by Lugano 2014 criteria (Appendix E) as assessed by investigator for epcoritamab in combination with other anti-neoplastic agents. • Anti-lymphoma activity of epcoritamab in combination with other anti-neoplastic agents: -Duration of response (DOR) determined per Lugano 2014 criteria as assessed by investigator -Progression free survival (PFS) determined per Lugano 2014 criteria as assessed by investigator -Complete Response (CR) rate determined per Lugano 2014 criteria as assessed by investigator -Time to response (TTR) determined per Lugano 2014 criteria as assessed by investigator -Time to next anti-lymphoma therapy (TTNT) -Rate and duration of Minimal Residual Disease (MRD) negativity -Overall survival (OS);Timepoint(s) of evaluation of this end point: These will be assessed throughout the study.

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Countries

Canada, Czechia, Denmark, France, Germany, Hungary, Israel, Japan, Korea, Republic of, Netherlands, Spain, Taiwan, United Kingdom, United States

Contacts

Public ContactGlobal Clinical Trials Helpdesk

AbbVie Ltd

abbvie_reec@abbvie.com+34901200103

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026