Last update 07 Nov 2024

Trastuzumab Rezetecan

Overview

Basic Info

Drug Type
Antibody drug conjugate (ADC)
Synonyms
Trastuzumab-rezetecan, SHR A1811, SHR-A1811
+ [1]
Target
Mechanism
HER2 antagonists(Receptor protein-tyrosine kinase erbB-2 antagonists)
Inactive Indication-
Inactive Organization-
Drug Highest PhaseNDA/BLA
First Approval Date-
RegulationOrphan Drug (US), Breakthrough Therapy (CN), Special Review Project (CN), Priority Review (CN)
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Structure

Molecular FormulaC26H34N6O7
InChIKeyLETKGXXMROUGGW-IBGZPJMESA-N
CAS Registry-
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R&D Status

10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
HER2 mutant non-small cell lung cancerNDA/BLA
CN
14 Sep 2024
Colorectal CancerPhase 3
CN
01 Mar 2024
HER2-positive gastric cancerPhase 3
CN
09 Jan 2024
HER2 positive Gastroesophageal Junction AdenocarcinomaPhase 3
CN
28 Dec 2023
HER2 positive Gastrooesophageal junction cancerPhase 3
CN
28 Dec 2023
HER2 Positive Breast CancerPhase 3-01 Oct 2023
HER2-Low Breast CarcinomaPhase 3
CN
05 Jun 2023
Metastatic human epidermal growth factor 2 positive carcinoma of breastPhase 3
CN
04 Aug 2022
Unresectable Breast CarcinomaPhase 3
CN
04 Aug 2022
Advanced gastric carcinomaPhase 2
CN
01 Dec 2024
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 1
307
aaxmttvjpb(ggbpbmlrxq) = kvbohyxybg vmjlvgaueu (riancpscfo )
Positive
10 Oct 2024
(HER2-positive breast cancer)
ucrtnopjce(vmxvgkzehg) = nybsvmnvrb nosznsigml (esbzyjovln )
Phase 2
29
tambmtibtq(lotulahaaa) = nchnbaxteg evbqzwnbha (cofppvlczj, 59.1 - 91.7)
Positive
16 Sep 2024
SHR-A1811 4.8 mg/kg+ Pyrotinib 240 mg/day
tambmtibtq(lotulahaaa) = fjypaymotp evbqzwnbha (cofppvlczj )
Phase 1/2
63
kzcibwixpu(aesrqlkwou) = nzjffsugrr nvfdivyfvl (gcifytouhw, 27.0 - 57.9)
Positive
15 Jul 2024
Phase 1
HER2 Positive Solid Tumors
ERBB2 Mutation (Activating) | HER2 Expression
307
xcsytzvfui(ysuphfqitu) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. xldtkoailz (tahsmukvzj )
Positive
20 Jun 2024
(HER2-positive breast cancer)
Phase 2
Salivary Gland Neoplasms
HER2 Negative | ERBB2 Amplification | HER2 Overexpression | ...
21
(HER2 mutation/amplification or HER2 overexpression (IHC 3+ or IHC 2+/ISH+))
ctdxtcccoy(exwnapglhy) = rvwbxrjhrf ufpkwfzmyi (ktedslnsnc )
Positive
24 May 2024
rezvilutamide + leuprolide
(IHC AR+)
ctdxtcccoy(exwnapglhy) = tkbcmgnrpx ufpkwfzmyi (ktedslnsnc )
Phase 1
98
ghuodugslr(ffemapdflr) = wbhzdsibxm tiacdwihnt (byoktjlaxs )
Positive
23 Oct 2023
(All GC/GEJ)
xxxieusvib(pghscysnfb) = ewghmmxyux fuedkcocmt (tzfjovfgfg, 71.2 - 92.2)
Phase 1
98
puorzxyecd(ihrjimjuoz) = yhmigiyamk ggkoahoext (vqsvopxpqg )
Positive
23 Oct 2023
(HER2 IHC3+)
tdatcabcie(smsezyjkxc) = kykqhjvztc fzctdffhsu (tyofpxzhja )
Phase 1/2
50
ckslmwggcf(akgslnovmu) = gfdvahwgbz lwcamuevtp (zbwdvbxend )
Positive
14 Apr 2023
AACR2023
ManualManual
Phase 1
250
vooetkkimv(olrjunpvzq) = qdltmncnde bucjrvyrmg (kecjlgeaoj )
Positive
14 Apr 2023
(HER2 positive breast cancer)
kpzjpoxbwn(ugoqotemla) = whlenxgfpq mejcabssvk (llmepiruxg, 72.9 - 88.3)
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Deal

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Core Patent

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Clinical Trial

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Approval

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Regulation

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