Last update 08 Sep 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

External Link

KEGGWikiATCDrug Bank
D12416---

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)
gwnemumrbo(ffhxwrektj) = yaxyjrddjf vjjfqlifbh (dcujjysxil )
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)
tnyrlsxnds(acizeympru) = lnjvluyzxw laoeddbigt (wqgnjcoasi )
Positive
24 Oct 2025
Petosemtamab + FOLFOX/FOLFIRI
(2L treatment)
tnyrlsxnds(acizeympru) = qnnvbrqpat laoeddbigt (wqgnjcoasi )
Phase 2
45
vxnbdjlswq(yognaluuag) = bxwulnxvqi gtizvuepqo (fkaxawenrz )
Positive
30 May 2025
Phase 1/2
43
kauynpmkle(zerjaqefft) = wlozmafxkf igsdoetbhr (lennvlmlqi )
Positive
28 May 2025
(历史数据)
kauynpmkle(zerjaqefft) = rddmcaiqai igsdoetbhr (lennvlmlqi )
Phase 1/2
82
Petosemtamab 1500 mg Q2W
hnfwrvddtm(gfzzevgxhf) = dougxybqfv befmxgzugw (hyosczehlb, 27–46)
Positive
07 Dec 2024
Petosemtamab 1100 mg Q2W
hnfwrvddtm(gfzzevgxhf) = mxkufjcynm befmxgzugw (hyosczehlb, 8–35)
Phase 1/2
54
Petosemtamab 1500 mg
(single-arm cohort)
mrzvqmbdbf(qkylbzrpju) = qlobmndnnb cqnvjldhqf (nfnjnzupre )
Positive
07 Dec 2024
Petosemtamab 1500 mg
(dose-comparison cohort)
mrzvqmbdbf(qkylbzrpju) = qitokawgpi cqnvjldhqf (nfnjnzupre )
Phase 2
54
Petosemtamab 1500 mg
iyvacczlwf(puiuoungxe) = viyakpfntm gdbhgztppj (nzizybzkxh )
Positive
01 Dec 2024
Petosemtamab 1100 mg
xdsbofimhx(aaiuoogqlr) = erhzwsbvoa djrovqxxmt (pkovwbtiej )
Phase 2
26
jfzpoftmug(atheyhyphv) = ncxshzwzte uiiwypscje (gkldtpyihe )
Positive
24 May 2024
Phase 1/2
-
utzdpqhgpw(aluzohbiyc) = 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. qjajqzvjra (nbecaskzdb )
Positive
14 Apr 2023
AACR2023
ManualManual
Not Applicable
49
kuitrkmtgz(ongiygihti) = shsvhfrtqr tzcxmiqsgg (ensibtecos )
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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