Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Lymphoma, Large B-Cell, Diffuse

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

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.

Epcoritamab

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.

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.

Expanded Access Program for Epcoritamab

Expanded Access Program (EAP) to Provide Epcoritamab (GEN3013) to Eligible Patients With Relapsed or Refractory Large B-cell Lymphoma

AbbVie

Genmab

Heart and Blood Diseases

Multiple Myeloma

Neoplasms, Plasma Cell

Hemostatic Disorders

Blood Coagulation Disorders

Vascular Diseases

Paraproteinemias

Blood Protein Disorders

Hematologic Diseases

Hemorrhagic Disorders

Antineoplastic Agents

Immunomodulating Agents

Daratumumab

Proteasome Inhibitors

Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.

Janssen Research & Development, LLC Clinical Trial

The objective of this study is to provide early access to daratumumab treatment and collect additional safety data while the medication is not commercially available or available through another protocol for subjects with multiple myeloma who have received at least 3 prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or whose disease is double refractory to both a PI and an IMiD.

This is a multicenter, open-label, early access treatment protocol of single-agent daratumumab in subjects with multiple myeloma who have received at least 3 prior lines of therapy including a PI and an IMiD or whose disease is double refractory to both a PI and an IMiD, who reside in areas where daratumumab is not commercially available or available through another protocol, who have not been enrolled in another daratumumab study, and who are not eligible for or who do not have access to enrollment in another ongoing clinical study of daratumumab. The study will have three phases: Screening phase (30 days prior to first dose of study drug), treatment phase (until documented progression, unacceptable toxicity, or study end), End of Treatment (30 days after last dose of study drug). Participants will receive daratumumab (16 milligram per kilogram \[mg/kg\]) as intravenous infusion. Participants will primarily be assessed for overall response rate. Safety will be monitored throughout the study.

Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma

An Open-Label Treatment Use Protocol for Daratumumab in Subjects With Multiple Myeloma Who Have Received at Least 3 Prior Lines of Therapy (Including a Proteasome Inhibitor and an Immunomodulatory Agent) or Are Double Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent

Janssen Research & Development, LLC

Respiratory Tract (Lung and Bronchial) Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Symptoms and General Pathology

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Pancreatic Neoplasms

Cholangiocarcinoma

Carcinoma, Renal Cell

Head and Neck Neoplasms

Neoplasms, Unknown Primary

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Urogenital Neoplasms

Urogenital Diseases

Male Urogenital Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Kidney Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Neoplasm Metastasis

Neoplastic Processes

Pancreatic Cancer

Bile Duct Cancer

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Gastrointestinal Agents

Pancrelipase

Pancreatin

MCLA-128

For Information

Merus is providing single patient/named access to the HER2/HER3 bispecific antibody, MCLA-128, to patients with advanced NRG1-fusion positive solid tumor under this early access program who are ineligible for an ongoing MCLA-128 clinical trial or have other considerations that prevent access to MCLA-128 through an existing clinical trial. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual's medical history and program eligibility criteria.

Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Treatment Plan of the HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor

Merus N.V.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Expanded Access Program for Epcoritamab	NCT05733650	Large B-cell Ly... Diffuse Large B... Primary Mediast... High Grade B-ce... Grade 3B Follic...	Epcoritamab	18 Years -	Genmab
Expanded Access Program for Epcoritamab	NCT05733650	Large B-cell Ly... Diffuse Large B... Primary Mediast... High Grade B-ce... Grade 3B Follic...	Epcoritamab	18 Years -	Genmab
Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma	NCT02477891	Multiple Myelom...	Daratumumab	18 Years -	Janssen Research & Development, LLC
Early Access Program Providing HER2/HER3 Bispecific Antibody, MCLA-128, for a Patient With Advanced NRG1-Fusion Positive Solid Tumor	NCT04100694	NRG1 Fusion Pancreatic Canc... Non Small Cell ... Solid Tumor, Un... Prostate Cancer Head and Neck C... Colorectal Canc... Breast Cancer Cholangiocarcin... Renal Cell Carc... Unknown Primary...	MCLA-128	18 Years -	Merus N.V.
Early Access Treatment With Daratumumab for (Relapsed or Refractory) Multiple Myeloma	NCT02477891	Multiple Myelom...	Daratumumab	18 Years -	Janssen Research & Development, LLC

Spots Global Cancer Trial Database for early access

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