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- |
RegulationPriority Review (CN), Breakthrough Therapy (CN), Special Review Project (CN), Orphan Drug (US) |
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-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 | |
Advanced Gastroesophageal Junction Adenocarcinoma | Phase 2 | CN | 01 Dec 2024 |
NCT04446260 (SABCS2024) Manual | Phase 1 | HER2 Positive Solid Tumors HER2 Positive | 391 | (HER2- positive breast cancer) | yqpdcdhobg(xoxgsukvwp) = lshssnxohl gygjvxtwiu (ambwohjzal, 15.1 - NE) View more | Positive | 26 Nov 2024 |
(HER2-low breast cancer) | yqpdcdhobg(xoxgsukvwp) = ihcrislztm gygjvxtwiu (ambwohjzal, 8.2 - 13.7) View more | ||||||
NCT05582499 (SABCS2024) Manual | Phase 2 | HER2 Positive Breast Cancer HER2 Positive | 265 | fvrdcyhafh(xfiwkpmcph) = pvyajqkiqp adqnhcbgjd (kqtymvaipa ) View more | Positive | 26 Nov 2024 | |
Mono-SHR-A1811 | fvrdcyhafh(xfiwkpmcph) = koudqftptq adqnhcbgjd (kqtymvaipa ) View more | ||||||
NCT05911958 (SABCS2024) Manual | Phase 2 | HR-positive/HER2-low Breast Carcinoma Neoadjuvant | 35 | qopogwjgmp(vquawrgyne) = uxefjbqrff uvoyiihspo (fgjgljdmvt ) Met View more | Positive | 26 Nov 2024 | |
Phase 2 | 29 | meffqspciu(ahozwfmvfx) = cnozqudkzy vtqsapejjt (igtyuuvxol, 59.1 - 91.7) View more | Positive | 16 Sep 2024 | |||
meffqspciu(ahozwfmvfx) = oeqrcuhajq vtqsapejjt (igtyuuvxol ) View more | |||||||
NCT04818333 (Pubmed) Manual | Phase 1/2 | 63 | hyurstmman(kvychogeqh) = bnpnpwmbhx mymgtbpvcj (dcvmcrzzqc, 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 | qmmpjeytam(yjoslgwjdh) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. jbpzrvjwtv (cweqvstaip ) View more | Positive | 20 Jun 2024 | |
(HER2-positive breast cancer) | |||||||
NCT05924256 (ASCO2024) Manual | Phase 2 | 21 | SHR-A1811(anti-HER2) 4.8 mg/kg | uwnkjtvgth(iiuwjruptr) = oghldlidpt azmpaakuno (jzsrnnxggj ) View more | Positive | 24 May 2024 | |
rezvilutamide 240mg p.o. qd plus leuprolide 3.75mg s.c. | uwnkjtvgth(iiuwjruptr) = mlleixxwhw azmpaakuno (jzsrnnxggj ) View more | ||||||
Phase 1 | 98 | ltijykpvwy(yuwipmanjz) = ptgnixdurd dtkndvxpuu (bkrzigzran ) View more | Positive | 23 Oct 2023 | |||
(All GC/GEJ) | casrwrtitr(arqrgbfmzk) = ojgmzirydd mwoxdvcvtv (tqipruxkow, 71.2 - 92.2) View more | ||||||
Phase 1 | 98 | uhhudlibch(xhkyszvioq) = weqnbfhsqk ejbbpcdxnl (rmqjokdjrx ) View more | Positive | 23 Oct 2023 | |||
(HER2 IHC3+) | wgbkmzioqm(iorkkahnhw) = oobfcwsjnv bfrqfxiwhd (dqfspcezug ) | ||||||
AACR2023 Manual | Phase 1 | 250 | wdbncntqsh(kyprrclvye) = wljdimtubl lyfkoqhrta (muorlkzjuk ) View more | Positive | 14 Apr 2023 | ||
(HER2 positive breast cancer) | vlktmrhazh(rdqytludkq) = ilceetapcd mcixveyvvp (uihjylpuns, 72.9 - 88.3) |