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Epcoritamab

Phase 2

Large B Cell Lymphoma | Small molecule | Oncology |Incyte Corporation|Last Updated: Aug 17, 2025

Target and mechanism

Molecular targetMS4A1, CD3E, CD3G, CD3D
Target classBinding Agent
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment80

FDA Designations

No designations recorded

Clinical trial landscape

Epcoritamab · 1 trial · 1 indication

Phase 2 1
NCT07126236Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell LymphomaLarge B Cell Lymphoma
RECRUITING80 Analytics
PHASE2RECRUITING
Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma
Large B Cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy of Epcoritamab monotherapy
Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.

The efficacy of Epcoritamab monotherapy will be centrally evaluated by the best CRR at any moment since initiation. The CRR will be assessed by PET-CT according to Lugano Classification and is defined as the proportion of patients who achieve a best response of complete response (CR) at any moment since initiation of Epcoritamab first administration.

Secondary Endpoints

Efficacy of Epcoritamab monotherapy after 3 cycles
At the end of cycle 3 (each cycle is 28 days)
Efficacy of Epcoritamab monotherapy and combination therapy by CRR
Cycle 3, cycle 4, cycle 7, cycle 10, cycle 13 (for combination therapy) and EoT (28 days after last administration of investigational product) visits. Each cycle is 28 days.
Evaluation of MRD
Cycles 3, 4, 7, 10, 12, 13, 15 (each cycle is 28 days), EoT (28 days after last administration of Study drug) and cycles 18 and 24 (epcoritamab monotherapy) or cycles 21 and 27 (combination therapy) visits (each cycle is 28 days).
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
EPCO monotherapyEXPERIMENTALEpcoritamab in monotherapy will be administred until cycle 12.
Combination therapyEXPERIMENTAL3 cycles of Epcoritamab in monotherapy will be administred and then Epcoritamab will be administred with Tafasitamab and Lenalidomide from cycle 4 until cycle 15.

Interventions

NameTypeDescription
EpcoritamabDRUGPatients will receive 12 cycles of Epcoritamab monotherapy.
Epcoritamab, tafasitamab and lenalidomideDRUGPatients will receive 3 cycles of Epcoritamab monotherapy and then 12 cycles of Epcoritamab, Tafasitamab and Lenalidomide.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites15

Inclusion Criteria: 1. Written informed consent must be obtained before any study-specific assessment is performed. 2. Age \>18 years 3. Patients with Relapse/Refractory histologically confirmed LBCL, including, Diffuse Large B Cell Lymphoma (DLBCL); Primary Mediastinal Large B Cell Lymphoma (PMBCL...

Countries:Spain
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Frequently asked questions about Epcoritamab

What is Epcoritamab used for in Large B Cell Lymphoma?

Epcoritamab is an investigational drug being studied for the treatment of patients with relapsed or refractory Large B Cell Lymphoma. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in a clinical trial to assess its efficacy in this patient population.

What does Epcoritamab target?

Epcoritamab is a monoclonal antibody, indicated by its -mab suffix. As an antibody-based therapy, it is designed to bind to specific targets on cells. However, the specific molecular target of Epcoritamab has not been disclosed in the available information.

Who makes Epcoritamab?

Epcoritamab is being developed by Incyte Corporation, a biopharmaceutical company traded on the stock exchange under the ticker symbol INCY. The company is conducting a Phase 2 clinical trial to evaluate the drug in patients with relapsed or refractory Large B Cell Lymphoma.

What phase is Epcoritamab in?

Epcoritamab is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA or any other regulatory agency. The ongoing Phase 2 trial is recruiting patients to evaluate the drug's efficacy in relapsed or refractory Large B Cell Lymphoma.

What clinical trials is Epcoritamab in?

Epcoritamab is being studied in one active clinical trial with the identifier NCT07126236. This Phase 2 trial is titled 'Response-adaptive to Epcoritamab In First Relapse: Study to Evaluate the Efficacy of Eptoritamab in Patients With Relapse/Refractory Large B Cell Lymphoma' and is recruiting participants in Spain. The trial is expected to enroll 80 patients aged 18 years and older.

Is Epcoritamab the same as Eptoritamab?

Epcoritamab is also referred to as Eptoritamab in some contexts, as seen in the clinical trial title for NCT07126236. Both names appear to refer to the same investigational drug being developed by Incyte Corporation for the treatment of relapsed or refractory Large B Cell Lymphoma.