Expanded Access Program for Epcoritamab

NCT ID: NCT05733650

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: APPROVED_FOR_MARKETING
• Study Classification: EXPANDED_ACCESS

Brief Summary

The purpose of this program is to provide investigational epcoritamab, an antibody also known as GEN3013 (DuoBody-CD3xCD20), in an expanded access setting for eligible patients with relapsed and/or refractory (R/R) large B-cell lymphoma (LBCL) who have a high unmet medical need with no other treatment options. It is a requirement that patients do not qualify for an ongoing epcoritamab clinical program or are unable to participate due to logistical reasons.

Access to investigational epcoritamab can be requested by contacting preapprovalaccessprograms@genmab.com.

Detailed Description

This is a multicenter program conducted within the United States. The program will consist of screening, treatment (Cycle 1 Day 1 until epcoritamab discontinuation), safety follow-up, post-treatment and/or survival follow-up.

Conditions

Large B-cell Lymphoma; Diffuse Large B-Cell Lymphoma, Not Otherwise Specified; Primary Mediastinal Large B-cell Lymphoma (PMBCL); High Grade B-cell Lymphoma (HGBCL); Grade 3B Follicular Lymphoma

Interventions

Epcoritamab

Eligible patients will receive epcoritamab (28-day cycle) that will be administered as subcutaneous (SC) injections until disease progression, or one or more of the treatment discontinuation criteria are met.

Intervention Type: BIOLOGICAL

Other Intervention Names

GEN3013; DuoBody®-CD3xCD20

Eligibility Criteria

Inclusion Criteria

• Must be 18 years of age or older
• R/R CD20+ mature B-cell neoplasm
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0, 1, or 2
• ≥ 2 prior lines of antineoplastic therapy, including ≥ 1 anti-CD20 monoclonal antibody (mAb)
• Fluorodeoxyglucose (FDG) positron emission tomography (PET)-avid and measurable disease by computed tomography/magnetic resonance imaging (CT/MRI)
• Patients considering the EAP should have no other available therapeutic option and cannot be eligible for other epcoritamab trials.
• Patients considering the EAP must be located in proximity to a US site given that the EAP is currently available only in the United States.
• Prior to initiating any program-related assessments or procedures, patients (or their legally acceptable representative) must sign an informed consent form (ICF), which indicates the purpose of the program, the procedures required for the program, and confirms the patient's willingness to participate in the program.

Exclusion Criteria

• Any prior therapy with an investigational bispecific antibody targeting CD3 and CD20
• Prior treatment with CAR-T therapy within 100 days prior to first epcoritamab administration
• Primary central nervous system (CNS) lymphoma or known CNS involvement by lymphoma
• Confirmed history of or current autoimmune disease or other diseases resulting in permanent immunosuppression or requiring permanent immunosuppressive therapy. Low-dose prednisolone for rheumatoid arthritis or similar conditions is allowed.
• Active hepatitis B or hepatitis C
• Known clinically significant cardiac disease
• Pregnancy or breastfeeding
• Known hypersensitivity to allopurinol or rasburicase

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: collaborator

Genmab

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

GCT3013-101

Identifier Type: -

Identifier Source: org_study_id