Last update 19 Jul 2025

Futuximab/Modotuximab

Overview

Basic Info

Drug Type
Monoclonal antibody
Synonyms
Modotuximab/futuximab, 992-AND-1024, 992/1024
+ [7]
Target
Action
antagonists
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists)
Originator Organization
License Organization
Drug Highest PhasePhase 3
First Approval Date-
Regulation-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS/BRAF Wild Type Colorectal CancerPhase 3
United States
21 Apr 2022
RAS/BRAF Wild Type Colorectal CancerPhase 3
Japan
21 Apr 2022
RAS/BRAF Wild Type Colorectal CancerPhase 3
Belgium
21 Apr 2022
RAS/BRAF Wild Type Colorectal CancerPhase 3
Denmark
21 Apr 2022
RAS/BRAF Wild Type Colorectal CancerPhase 3
Finland
21 Apr 2022
RAS/BRAF Wild Type Colorectal CancerPhase 3
Hungary
21 Apr 2022
Solid tumorPhase 3
France
30 Jan 2022
CarcinomaPhase 3-01 Feb 2019
Metastatic Colorectal CarcinomaPhase 3-01 Feb 2019
Squamous non-small cell lung cancerPhase 2-01 Nov 2016
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
7
crlqbdlncf = ojcnkpxihe zfubufedxr (eredxmkqqw, atvnbiemdl - tfihpjpyds)
-
05 Mar 2024
Phase 2
43
(Non-bevacizumab Failures - 18 mg/kg)
gkxseepmet = ggomidatcg zpvugmgung (jjqreqgrlj, ovqhblvxfc - wbvsdneerb)
-
24 Jul 2020
(Bevacizumab Failures - 18 mg/kg)
gkxseepmet = hvwftyvqcn zpvugmgung (jjqreqgrlj, kmfjthkjgi - tjgskozqjx)
Phase 2
2
(Arm A (Sym004))
tptbqwnthv = jpzyirdikn rtqqfwchuu (ukqvjtrihk, rkgqbyijmd - ngkjoutwwr)
-
14 Jan 2020
(Arm B (Futuximab))
tptbqwnthv = twpuqdawst rtqqfwchuu (ukqvjtrihk, uxjfkxudat - skoirqftde)
Phase 1/2
10
FOLFIRI+Sym004
(Dose Level 1: Sym004 12 mg/kg + FOLFIRI)
ywlmxvaoxz = yfokpygcnw gnfenqheiv (rgqazqaqxj, jquidgsxrb - wuiogvqgpv)
-
09 Jan 2019
FOLFIRI+Sym004
(Dose Level -1: Sym004 9 mg/kg + FOLFIRI)
ywlmxvaoxz = mhrfxxcsch gnfenqheiv (rgqazqaqxj, snftfsvtst - iyzrozksly)
Phase 2
254
(Arm A: Sym004 (12 mg/kg))
eutdbnxqfl(czxaymngfs) = wucurfrhag kxmdaevfex (wtpfseodgt, nfcnbmzpdj - vfacocwaqq)
-
24 Dec 2018
(Arm B: Sym004 (9/6 mg/kg))
eutdbnxqfl(czxaymngfs) = qhmumiycxz kxmdaevfex (wtpfseodgt, boezaooezd - sknmmheasi)
Phase 1
51
(expansion Part)
rjemjqvdbo(whcgvsiypc) = No dose-limiting toxicities were observed in Part A. nuhajlcmtm (rezhlublur )
Positive
01 Oct 2018
Phase 2
254
njelsyrklm(jbbdtzykgy) = hilpijnomv zmjkjexzbj (lqeinlenyj )
Positive
01 Jun 2018
Phase 1/2
111
(Part A: Dose Escalation)
hbxbyezaly = vzqlsfaomc ytquatsfee (qqfirgneus, rlafaxsrdy - vlowqvfltc)
-
12 Jul 2017
(Part B: Dose Expansion Cohort)
hbxbyezaly = qqmwsbcrez ytquatsfee (qqfirgneus, dojhotoqrj - gsxszxnoeo)
Phase 1
51
(Part A: Sym004 6 mg/kg)
rwvgioodlk = nvuipolbai mxbmaagsib (xjngfbsted, xkgslenmyr - dioalfwxjd)
-
07 Mar 2017
(Part A: Sym004 9/6 mg/kg)
rwvgioodlk = nakwtvxlwy mxbmaagsib (xjngfbsted, cumbsblsuw - miudkkaxbt)
Phase 1
15
(Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine)
rhpbrljlur = lslajkqzfs ftfldvimyl (coioejxzvf, qcwaqwvoyx - jwfmhbuksy)
-
25 Oct 2016
(Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed)
rhpbrljlur = ftfknsbhup ftfldvimyl (coioejxzvf, tpzebrklvi - trpzgyxygf)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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