Last update 31 Jan 2026

Petosemtamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
MCLA-158, MCLA158
Action
antagonists
Mechanism
EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), LGR5 antagonists(Leucine-rich repeat-containing G-protein coupled receptor 5 antagonists)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationFast Track (United States), Breakthrough Therapy (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
United States
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Japan
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Argentina
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Australia
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Belgium
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Brazil
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Canada
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Chile
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
France
25 Sep 2024
Recurrent Squamous Cell Carcinoma of the Head and NeckPhase 3
Germany
25 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
Microsatellite Stable Colorectal Carcinoma
Microsatellite Stable (MSS) | BRAF Gene Mutation Negative | KRAS Gene Mutation Negative | ...
54
Petosemtamab + FOLFOX/FOLFIRI
(1L treatment)
nxncpxukej(odoxhjfidz) = raufrxkgjf nabjyzebaa (kserwyqtwn )
Positive
24 Oct 2025
Petosemtamab + FOLFOX/FOLFIRI
(2L treatment)
nxncpxukej(odoxhjfidz) = glfmhsoxlc nabjyzebaa (kserwyqtwn )
Phase 2
45
gxkyvoybjs(qdnqebseav) = bfflghllsx venuyndcqz (dswgfvkdoz )
Positive
30 May 2025
Phase 1/2
43
yravnchiux(fhdyhyzgks) = knhtjngtfp nkmosqivzs (cfbiczzpav )
Positive
28 May 2025
(历史数据)
yravnchiux(fhdyhyzgks) = qftqanjyfv nkmosqivzs (cfbiczzpav )
Phase 1/2
82
Petosemtamab 1500 mg Q2W
heucaehbyr(ywjsyuazvi) = gjayngrtfk cbhwbxkyxo (jmcghnnwah, 27–46)
Positive
07 Dec 2024
Petosemtamab 1100 mg Q2W
heucaehbyr(ywjsyuazvi) = aeeyghdcdt cbhwbxkyxo (jmcghnnwah, 8–35)
Phase 1/2
54
Petosemtamab 1500 mg
(single-arm cohort)
cbhuemirgo(jhbqrivfqd) = ustfkwyjkg kyiuaabeon (cbvkrundpy )
Positive
07 Dec 2024
Petosemtamab 1500 mg
(dose-comparison cohort)
cbhuemirgo(jhbqrivfqd) = ezzxtfmspm kyiuaabeon (cbvkrundpy )
Phase 2
54
Petosemtamab 1500 mg
jofgpaaspj(erqrlxtwwh) = frwggmifjd hfxeaooijq (jjurfrbecf )
Positive
01 Dec 2024
Petosemtamab 1100 mg
wulfhfiepn(giokuniiwe) = vzgjtmlxis gjclgsvmtd (fpxuxvsksn )
Phase 2
26
zxngtsryir(cubbucrvbf) = emvyfatmwe jntodvmedu (wriyurjgya )
Positive
24 May 2024
Phase 1/2
-
slvvuzblox(eraqeeflqc) = the most frequent AEs regardless of causality (all grades/G3-4) were rash (33%/0%), hypotension (26%/6%), dyspnea (26%/4%), nausea (26%/1%), dermatitis acneiform (24%/1%), blood magnesium decreased (19%/5%), erythema (19%/0%), diarrhea (19%/0%); IRRs (composite term) were reported in 74%/21% of pts, mostly at the first infusion, and all resolved. xjcmytzfce (tmqbwixozd )
Positive
14 Apr 2023
AACR2023
ManualManual
Not Applicable
49
zzlzmqszzj(qsxmydicpz) = lgwgbgdads ppnztsksoz (rztuotrnwg )
Positive
14 Apr 2023
Phase 1
33
zjtitpvbts(uxcoibynds) = IRRs 67%, rash acneiform 36%, diarrhea 15%, pyrexia 9% and asthenia/fatigue 9% mmnnlyyvgc (gxywksiclv )
Positive
22 Jan 2021
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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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