CDEK
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tebentafusp

Trade name: Kimmtrak

Recombinant proteinapprovedBi-specificOrphan Drug FDABreakthrough Therapy FDA

Approved

Jan 25, 2022

Clinical trial activity

18 trials · 18 clinical orgs · 1 marketing orgs

Phase 1
6
Phase 2
13
Phase 3
3
Phase 4
0

Earliest trial started Sep 1, 2010 (NCT01209676)

Timeline

2010s

  1. Jan 1, 2010

    Earliest Phase 1 Sponsor(trial)

  2. Jan 21, 2016

    Orphan Drug Designation

  3. Jan 1, 2017

    Immunocore Ltd — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jan 25, 2022

    Immunocore Ltd — Earliest FDA Approval

  2. Jan 25, 2022

    Immunocore Ltd — Marketing Organization

  3. Jan 25, 2022

    Immunocore Ltd — NDA Secondary Org

  4. Jan 25, 2022

    Immunocore Ltd — NDA Organization

  5. Jan 1, 2024

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedBreakthroughJan 25, 2022

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 warningFirst in class

Sources

Also known as

  • imcgp100

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07276386Phase 2Dec 31, 2025Delcath Systems, University of South Florida
NCT06942442Phase 2Oct 22, 2025Memorial Sloan-Kettering Cancer Center, Royal Marsden Hospital NHS Trust, Sarcoma Alliance for Research through Collaboration
NCT07057596Phase 2Jul 18, 2025Grupo Español Multidisciplinar de Melanoma
NCT06414590Phase 2Jan 31, 2025Thomas Jefferson University
NCT06627244Phase 2Dec 1, 2024Immunocore Ltd, University of Miami
NCT06626516Phase 1/Phase 2 (Phase 2)Oct 31, 2024Thomas Jefferson University
NCT06246149Phase 3Oct 31, 2024European Organisation for Research and Treatment of Cancer, Immunocore Ltd, Northwell Health
NCT06556368Phase 3Aug 23, 2024Kodiak Sciences Inc
NCT06070012Phase 2Nov 30, 2023Immunocore Ltd, University of Pittsburgh
NCT05549297Phase 2/Phase 3 (Phase 3)Nov 30, 2022Immunocore Ltd
NCT05315258Phase 2Jul 25, 2022Immunocore Ltd, Natera, Inc., University of Oxford
NCT03070392Phase 2Jun 1, 2017Immunocore Ltd
NCT02570308Phase 1Feb 1, 2016Immunocore Ltd
NCT02889861Phase 1/Phase 2 (Phase 2)Jan 18, 2016Immunocore Ltd
NCT02535078Phase 1/Phase 2 (Phase 2)Nov 1, 2015Immunocore Ltd, MedImmune
NCT01211262Phase 1Sep 28, 2010Immunocore Ltd
NCT01209676Early Phase 1 (Phase 1)Sep 1, 2010University of Pennsylvania
NCT04960891N/A—Clinigen, Inc., Immunocore Ltd
Showing 18 of 18 trials
Page 1 / 1

Organizations

Research & Development (18)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Immunocore LtdFor profit11742010
Thomas Jefferson UniversityAcademic/Hospital2212024
Clinigen, Inc.For profit101—
Delcath SystemsFor profit1012025
European Organisation for Research and Treatment of CancerAcademic/Hospital1112024
Grupo Español Multidisciplinar de MelanomaAcademic/Hospital1112025
Kodiak Sciences IncFor profit1112024
MedImmuneFor profit1012015
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1012025
Natera, Inc.For profit1012022
Northwell HealthAcademic/Hospital1012024
Royal Marsden Hospital NHS TrustAcademic/Hospital1012025
Sarcoma Alliance for Research through CollaborationAcademic/Hospital1112025
University of MiamiAcademic/Hospital1112024
University of OxfordAcademic/Hospital1112022
University of PennsylvaniaAcademic/Hospital1112010
University of PittsburghAcademic/Hospital1112023
University of South FloridaAcademic/Hospital1112025
18 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
Immunocore LtdFor profitMKTGJan 25, 2022
Immunocore LtdFor profitNDA2Jan 25, 2022
Immunocore LtdFor profitNDAJan 25, 2022