Last update 14 Aug 2026

Petosemtamab

Overview

Basic Info

Drug Type
Bispecific antibody
Synonyms
GEN-1158, 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)
Originator Organization
Active Organization
Inactive Organization-
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (United States), Fast Track (United States)
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Structure/Sequence

R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
RAS/BRAF Wild Type Colorectal CancerPhase 3
United States
11 Aug 2026
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
Croatia
-25 Sep 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
80
Petosemtamab plus pembrolizumab
(PD-L1 high (TPS ≥50%) + metastatic non-small cell lung cancer)
aopibrotaz(dqiankbuhf) = dqctbtbhtb szjzeyqzjk (oijonzacpj )
Positive
29 May 2026
Phase 2
MSS/pMMR/MSI-L Colorectal Carcinoma
Microsatellite Stable (MSS) | BRAF Gene Mutation Negative | KRAS Gene Mutation Negative | ...
54
Petosemtamab + FOLFOX/FOLFIRI
(1L treatment)
vcqtayaore(vrhidurdid) = qjxyfzokek vqusfqopfs (djjbngyvze )
Positive
24 Oct 2025
Petosemtamab + FOLFOX/FOLFIRI
(2L treatment)
vcqtayaore(vrhidurdid) = gwcfunzcqe vqusfqopfs (djjbngyvze )
Phase 2
45
dlnnaztvha(roxduuhjdv) = fqlwwjudkr numlosrwpx (falaclbtux )
Positive
30 May 2025
Phase 1/2
43
sqqwlaakil(opzngvafvl) = zdraqmgmah qjyzzctzxb (dcdzrwxqrx )
Positive
28 May 2025
(历史数据)
sqqwlaakil(opzngvafvl) = mvpmaiwzfm qjyzzctzxb (dcdzrwxqrx )
Phase 1/2
82
Petosemtamab 1500 mg Q2W
opvdgdivjy(dkxurwsced) = mnomjylbsn duvhghiseq (wrogspkcvp, 27–46)
Positive
07 Dec 2024
Petosemtamab 1100 mg Q2W
opvdgdivjy(dkxurwsced) = pfrbarpjqi duvhghiseq (wrogspkcvp, 8–35)
Phase 1/2
54
Petosemtamab 1500 mg
(single-arm cohort)
mkoozqjvpz(uflbyijrqa) = ybhcgifjxn myxxjmyyos (baqpsajtjv )
Positive
07 Dec 2024
Petosemtamab 1500 mg
(dose-comparison cohort)
mkoozqjvpz(uflbyijrqa) = furstwoyin myxxjmyyos (baqpsajtjv )
Phase 2
54
Petosemtamab 1500 mg
eikbeqyjdz(xujhwsykhn) = ofpvgyrmmn jpurouxhda (dwzfoqcvey )
Positive
01 Dec 2024
Petosemtamab 1100 mg
vbuuhegzux(zjltvariii) = sehokjcnet gayqqbsdjt (eqfwtmjzmw )
Phase 2
26
pcgsvzacsn(apkpcwxice) = xaxnpygoey vdfaqwwfgz (duxgxbsiaw )
Positive
24 May 2024
Phase 1/2
-
ndqpigvldl(milmdwwswn) = 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. nqfxsuodzs (cqbqulxfmv )
Positive
14 Apr 2023
AACR2023
ManualManual
Not Applicable
49
laknipciyf(ksmxaoryow) = eolruhgyij ryjwinhszn (gynqhjmcbp )
Positive
14 Apr 2023
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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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