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



| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | United States | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Japan | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Argentina | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Australia | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Belgium | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Brazil | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Canada | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Chile | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | France | 25 Sep 2024 | |
| Recurrent Squamous Cell Carcinoma of the Head and Neck | Phase 3 | Germany | 25 Sep 2024 |
Company_Website Manual | Phase 2 | Microsatellite Stable Colorectal Carcinoma Microsatellite Stable (MSS) | BRAF Gene Mutation Negative | KRAS Gene Mutation Negative | ... View more | 54 | Petosemtamab + FOLFOX/FOLFIRI (1L treatment) | qvuatjoqxt(mgpbkgwtej) = znbreestlc uuelwvoape (igbwzcuqjm ) View more | Positive | 24 Oct 2025 |
Petosemtamab + FOLFOX/FOLFIRI (2L treatment) | qvuatjoqxt(mgpbkgwtej) = sqxjcrvius uuelwvoape (igbwzcuqjm ) View more | ||||||
Phase 2 | Esophageal Carcinoma | Advanced Malignant Solid Neoplasm | Squamous Cell Carcinoma of Head and Neck ... First line PD-L1+ View more | 45 | qrupzetwbr(nijdbaaxvz) = zlcqsdjowv mymmubdard (mynptqbuqp ) View more | Positive | 30 May 2025 | ||
NCT03526835 (NEWS) Manual | Phase 1/2 | 43 | efczjvrfgl(hphspdryeq) = esziyygwod qwgrbucgep (hpyfmhggvj ) View more | Positive | 28 May 2025 | ||
(历史数据) | efczjvrfgl(hphspdryeq) = plgxmzsxpt qwgrbucgep (hpyfmhggvj ) | ||||||
Phase 1/2 | Squamous Cell Carcinoma of Head and Neck Second line | 54 | Petosemtamab 1500 mg (single-arm cohort) | lmazxaiidh(dzpylxzklh) = ngilpkthrs tfdnxvqsgl (oylmwtiidp ) View more | Positive | 07 Dec 2024 | |
Petosemtamab 1500 mg (dose-comparison cohort) | lmazxaiidh(dzpylxzklh) = arhrsrmteo tfdnxvqsgl (oylmwtiidp ) | ||||||
Company_Website Manual | Phase 1/2 | 82 | Petosemtamab 1500 mg Q2W | ikomjiadob(tteyjuaaie) = najqlqhhfl ehosbkotcq (mhfphwieiy, 27–46) View more | Positive | 07 Dec 2024 | |
Petosemtamab 1100 mg Q2W | ikomjiadob(tteyjuaaie) = rqwemjyygo ehosbkotcq (mhfphwieiy, 8–35) View more | ||||||
Phase 2 | Squamous Cell Carcinoma of Head and Neck Second line | 54 | Petosemtamab 1500 mg | aguhhfpkya(nlyhaeuhri) = ipybafqzhw csmravyqrw (lojrkicfqi ) View more | Positive | 01 Dec 2024 | |
Petosemtamab 1100 mg | sbisbcbnhc(yhqisqvgtm) = wfyymtqfum tlogqlmzfq (icboikqtir ) | ||||||
Phase 2 | Squamous Cell Carcinoma of Head and Neck First line | 26 | mlyamgblnl(zanyvnraoj) = ewrtbdgjcw iadchlvvvs (wukmnqjqts ) View more | Positive | 24 May 2024 | ||
AACR2023 Manual | Not Applicable | 49 | skeyiuambf(nzobwfjcwx) = rnbonhdycd nsscjanuag (codgwqgqsi ) View more | Positive | 14 Apr 2023 | ||
NCT03526835 (AACR2023) Manual | Phase 1/2 | - | xbfucmkpit(jexgodybxa) = 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. mtjbwcrrsd (sjalipvicf ) | Positive | 14 Apr 2023 | ||
Phase 1 | Metastatic Colorectal Carcinoma Last line | 33 | rqcwtszchc(hdldpgpowk) = IRRs 67%, rash acneiform 36%, diarrhea 15%, pyrexia 9% and asthenia/fatigue 9% qkorurzwuw (frhsphkqon ) View more | Positive | 22 Jan 2021 |






