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) |
Therapeutic Areas |
Active Indication |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhaseNDA/BLA |
First Approval Date- |
RegulationOrphan Drug (US), Breakthrough Therapy (CN), Special Review Project (CN), Priority Review (CN) |
Molecular FormulaC26H34N6O7 |
InChIKeyLETKGXXMROUGGW-IBGZPJMESA-N |
CAS Registry- |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
HER2 mutant non-small cell lung cancer | NDA/BLA | CN | 14 Sep 2024 | |
Colorectal Cancer | Phase 3 | CN | 01 Mar 2024 | |
HER2-positive gastric cancer | Phase 3 | CN | 09 Jan 2024 | |
HER2 positive Gastroesophageal Junction Adenocarcinoma | Phase 3 | CN | 28 Dec 2023 | |
HER2 positive Gastrooesophageal junction cancer | Phase 3 | CN | 28 Dec 2023 | |
HER2 Positive Breast Cancer | Phase 3 | - | 01 Oct 2023 | |
HER2-Low Breast Carcinoma | Phase 3 | CN | 05 Jun 2023 | |
Metastatic human epidermal growth factor 2 positive carcinoma of breast | Phase 3 | CN | 04 Aug 2022 | |
Unresectable Breast Carcinoma | Phase 3 | CN | 04 Aug 2022 | |
Advanced gastric carcinoma | Phase 2 | CN | 01 Dec 2024 |
Phase 1 | HER2 Positive Solid Tumors HER2 Positive | 307 | aaxmttvjpb(ggbpbmlrxq) = kvbohyxybg vmjlvgaueu (riancpscfo ) View more | 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) View more | Positive | 16 Sep 2024 | |||
tambmtibtq(lotulahaaa) = fjypaymotp evbqzwnbha (cofppvlczj ) View more | |||||||
NCT04818333 (Pubmed) Manual | Phase 1/2 | 63 | kzcibwixpu(aesrqlkwou) = nzjffsugrr nvfdivyfvl (gcifytouhw, 27.0 - 57.9) View more | Positive | 15 Jul 2024 | ||
NCT04446260 (Pubmed) Manual | 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 ) View more | Positive | 20 Jun 2024 | |
(HER2-positive breast cancer) | |||||||
NCT05924256 (ASCO2024) Manual | Phase 2 | 21 | (HER2 mutation/amplification or HER2 overexpression (IHC 3+ or IHC 2+/ISH+)) | ctdxtcccoy(exwnapglhy) = rvwbxrjhrf ufpkwfzmyi (ktedslnsnc ) View more | Positive | 24 May 2024 | |
rezvilutamide + leuprolide (IHC AR+) | ctdxtcccoy(exwnapglhy) = tkbcmgnrpx ufpkwfzmyi (ktedslnsnc ) View more | ||||||
NCT04513223 (ESMO2023) Manual | Phase 1 | 98 | ghuodugslr(ffemapdflr) = wbhzdsibxm tiacdwihnt (byoktjlaxs ) View more | Positive | 23 Oct 2023 | ||
(All GC/GEJ) | xxxieusvib(pghscysnfb) = ewghmmxyux fuedkcocmt (tzfjovfgfg, 71.2 - 92.2) View more | ||||||
NCT04446260 (ESMO2023) Manual | Phase 1 | 98 | puorzxyecd(ihrjimjuoz) = yhmigiyamk ggkoahoext (vqsvopxpqg ) View more | Positive | 23 Oct 2023 | ||
(HER2 IHC3+) | tdatcabcie(smsezyjkxc) = kykqhjvztc fzctdffhsu (tyofpxzhja ) | ||||||
NCT04818333 (AACR2023) Manual | Phase 1/2 | HER2 mutant non-small cell lung cancer HER2 Positive | 50 | ckslmwggcf(akgslnovmu) = gfdvahwgbz lwcamuevtp (zbwdvbxend ) View more | Positive | 14 Apr 2023 | |
AACR2023 Manual | Phase 1 | 250 | vooetkkimv(olrjunpvzq) = qdltmncnde bucjrvyrmg (kecjlgeaoj ) View more | Positive | 14 Apr 2023 | ||
(HER2 positive breast cancer) | kpzjpoxbwn(ugoqotemla) = whlenxgfpq mejcabssvk (llmepiruxg, 72.9 - 88.3) |