Epcoritamab
Trade name: Epkinly
mAbapprovedBi-specificOrphan Drug FDA
Approved
May 19, 2023
Clinical trial activity
48 trials · 39 clinical orgs · 1 marketing orgs
Phase 1
12
Phase 2
40
Phase 3
6
Phase 4
0
Earliest trial started Jun 26, 2018 (NCT03625037)
Timeline
Indications
Studied for
- Burkitt Lymphoma · Phase 2
- Cytokine Release Syndrome · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Lymphoma · Phase 2
- Lymphoma, B-Cell · Phase 2
- Lymphoma, B-Cell, Marginal Zone · Phase 2
- Lymphoma, Follicular · Phase 3
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, Primary Cutaneous Anaplastic Large Cell · Phase 1/Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoproliferative Disorders · Phase 2
- Medial Collateral Ligament, Knee · Phase 1/Phase 2
- Neoplasms · Phase 2
- Recurrence · Phase 2
- Squamous Intraepithelial Lesions · Phase 2
- Waldenstrom Macroglobulinemia · Phase 2
Mechanism of action
CD3E activator
- B-lymphocyte antigen CD20BINDING AGENT
MS4A1 binding agent
- T cell surface glycoprotein CD3BINDING AGENT
T cell surface glycoprotein CD3 binding agent
Directs cytotoxic T-cells to tumours
Approval history
- approvedPriority reviewAcceleratedMay 19, 2023
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- Yes (Bi-specific)
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- ChEMBLCHEMBL4650393 ↗
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07097363 | Phase 2 | Jan 1, 2026 | AbbVie, University of Washington |
| NCT07218510 | Phase 2 | Dec 9, 2025 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06919939 | Phase 2 | Dec 1, 2025 | ADC Therapeutics SARL, Genmab, University of Miami |
| NCT07197307 | Phase 2 | Oct 15, 2025 | AbbVie, Swedish Orphan Biovitrum, University of Munster |
| NCT07082868 | Phase 1 | Aug 13, 2025 | Memorial Sloan-Kettering Cancer Center |
| NCT07030699 | Phase 2 | Aug 13, 2025 | Genmab, Incyte, Memorial Sloan-Kettering Cancer Center |
| NCT07126236 | Phase 2 | Aug 4, 2025 | AbbVie, Evidenze Health España (CRO), Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea, Hospital General Universitario Gregorio Marañon, Incyte, Universidad Autonoma de Barcelona |
| NCT07108998 | Phase 2 | Aug 1, 2025 | Genmab, University of Cincinnati |
| NCT06905509 | Phase 2 | Jul 31, 2025 | National Cancer Institute (NCI), University of California, Davis |
| NCT06931652 | Phase 2 | Jul 31, 2025 | AbbVie, The Lymphoma Academic Research Organisation |
| NCT06811272 | Phase 2 | Jul 16, 2025 | Genmab, Harvard University |
| NCT06796998 | Phase 2 | May 1, 2025 | AbbVie, Genmab, University of Miami |
| NCT06672705 | Phase 1 | Mar 1, 2025 | AbbVie, Genmab, Ohio State University |
| NCT06563596 | Phase 2 | Feb 28, 2025 | BeOne Medicines, Genmab, Harvard University |
| NCT06723457 | Phase 2 | Feb 18, 2025 | National Cancer Institute (NCI), Northwestern University |
| NCT06510361 | Phase 2 | Dec 31, 2024 | Genmab, Harvard University |
| NCT06447376 | Phase 1 | Dec 1, 2024 | AbbVie, Case Western Reserve University, Genmab, Recordati, University of Rochester |
| NCT06575686 | Phase 2 | Nov 23, 2024 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT06676033 | Phase 1 | Nov 17, 2024 | National Heart, Lung, and Blood Institute (NHLBI) |
| NCT06510491 | Phase 2 | Oct 31, 2024 | Genmab, Harvard University |
Showing 20 of 48 trials
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Organizations
Research & Development (39)
39 organizations
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