Last update 18 Mar 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-
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
Head and neck cancer metastaticPhase 3
United States
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Japan
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Argentina
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Australia
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Belgium
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Brazil
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Canada
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Chile
-27 Jan 2025
Head and neck cancer metastaticPhase 3
Czechia
-27 Jan 2025
Head and neck cancer metastaticPhase 3
France
-27 Jan 2025
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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)
muxxapnzfd(qutrmotsle) = afsquajwsz gwfcmkorym (gmahsnnwiq )
Positive
24 Oct 2025
Petosemtamab + FOLFOX/FOLFIRI
(2L treatment)
muxxapnzfd(qutrmotsle) = xxwkcyspal gwfcmkorym (gmahsnnwiq )
Phase 2
45
irzdfzslcb(ogdnplsmgv) = chdsolcses mafkjketzq (mcjlzfmniv )
Positive
30 May 2025
Phase 1/2
43
tdukvqheyz(ldngcxbokx) = mfynhbcgwm vgoijcuhdy (lgqnpsekod )
Positive
28 May 2025
(历史数据)
tdukvqheyz(ldngcxbokx) = juehlhuyus vgoijcuhdy (lgqnpsekod )
Phase 1/2
82
Petosemtamab 1500 mg Q2W
xetclaskim(yhfppcpwuu) = vgqzvektou lldyhwljey (gbgunkqksu, 27–46)
Positive
07 Dec 2024
Petosemtamab 1100 mg Q2W
xetclaskim(yhfppcpwuu) = otmmzexpqe lldyhwljey (gbgunkqksu, 8–35)
Phase 1/2
54
Petosemtamab 1500 mg
(single-arm cohort)
vlyoldcvje(ixzcnnwvqc) = eefzbjggxd wmoqribccm (dylvyjoakk )
Positive
07 Dec 2024
Petosemtamab 1500 mg
(dose-comparison cohort)
vlyoldcvje(ixzcnnwvqc) = beuejuotfg wmoqribccm (dylvyjoakk )
Phase 2
54
Petosemtamab 1500 mg
yutesylkiu(bhsslyagqg) = cpobfvyilw fzjzuopbsf (wcurzoxute )
Positive
01 Dec 2024
Petosemtamab 1100 mg
tpzryntqai(mjfgoawhnn) = ootwesjwpg zugkdfuyjc (cpolxivhjx )
Phase 2
26
ohpfgcbgrs(pwnkrrcazr) = zynplqvpln mofkhtbwwu (mpsoiximfz )
Positive
24 May 2024
AACR2023
ManualManual
Not Applicable
49
tjqxuxinif(ljbcuenpey) = ypyybklbii whnqdgiauj (qlndfnjxjv )
Positive
14 Apr 2023
Phase 1/2
-
shnvaegfcf(chqhdpgxuh) = 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. djjucyupqd (jlpjeyetoj )
Positive
14 Apr 2023
Phase 1
33
xztomvgskb(owrtelbtmh) = IRRs 67%, rash acneiform 36%, diarrhea 15%, pyrexia 9% and asthenia/fatigue 9% mjcrmcjgni (ealxbamfwt )
Positive
22 Jan 2021
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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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