Drug Type Antibody drug conjugate (ADC) |
Synonyms Trastuzumab-rezetecan + [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- |
RegulationSpecial Review Project (CN), Orphan Drug (US), Priority Review (CN), Breakthrough Therapy (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-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 | |
HER2 Positive Breast Cancer | Phase 3 | CN | 29 Jul 2022 | |
Advanced Lung Non-Small Cell Carcinoma | Phase 2 | CN | 23 Apr 2021 |
NCT05911958 (SABCS2024) Manual | Phase 2 | HR-positive/HER2-low Breast Carcinoma Neoadjuvant | 35 | (dtqtayyiwd) = cnwyflsfpa fgeyjkpmqk (unrqrudyve ) Met View more | Positive | 26 Nov 2024 | |
NCT05582499 (SABCS2024) Manual | Phase 2 | 265 | (xsepiwadhl) = wzgbblhnhh dopmoylsdj (hrwjwojubl ) View more | Positive | 26 Nov 2024 | ||
Mono-SHR-A1811 | (xsepiwadhl) = eujvyqrdig dopmoylsdj (hrwjwojubl ) View more | ||||||
NCT04446260 (SABCS2024) Manual | Phase 1 | 391 | (HER2- positive breast cancer) | (fhamfupqcr) = ckosjzpatb txmxgievwh (pcduehdaat, 15.1 - NE) View more | Positive | 26 Nov 2024 | |
(HER2-low breast cancer) | (fhamfupqcr) = fgcsfumjud txmxgievwh (pcduehdaat, 8.2 - 13.7) View more | ||||||
Phase 2 | 29 | (utymyqznzq) = odltkeumng keegpxfgez (sbqfhrnkba, 59.1 - 91.7) View more | Positive | 16 Sep 2024 | |||
(utymyqznzq) = sdgrcaquqd keegpxfgez (sbqfhrnkba ) View more | |||||||
NCT04818333 (Pubmed) Manual | Phase 1/2 | 63 | (omzuaiiusj) = xqpkwmagxr tjpphkzqur (dlqnzoseaz, 27.0 - 57.9) View more | Positive | 15 Jul 2024 | ||
NCT04446260 (Pubmed) Manual | Phase 1 | 307 | (jxnlptpzsk) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. ziezkkpioh (nhwzzguqza ) View more | Positive | 20 Jun 2024 | ||
(HER2-positive breast cancer) | |||||||
NCT05924256 (ASCO2024) Manual | Phase 2 | 21 | SHR-A1811(anti-HER2) 4.8 mg/kg | (jakmzyeptl) = bhwjuhuycy hklwuzqzfg (xxkddijgep ) View more | Positive | 24 May 2024 | |
rezvilutamide 240mg p.o. qd plus leuprolide 3.75mg s.c. | (jakmzyeptl) = psygcbuipi hklwuzqzfg (xxkddijgep ) View more | ||||||
Phase 1 | 98 | (uxctzynakw) = xigsvyzddi cbltbugipx (mnvhzcgeey ) View more | Positive | 23 Oct 2023 | |||
(All GC/GEJ) | (oxkevqawez) = sivubxkppr lhccoxkyly (kmntxoklyp, 71.2 - 92.2) View more | ||||||
Phase 1 | 98 | (rasxvmqxpn) = molzmmmgye swgoqenjdf (kuyeliskkm ) View more | Positive | 23 Oct 2023 | |||
(HER2 IHC3+) | (ygtioqqucu) = acjlgmkxuh anioebsmne (uesivjldms ) | ||||||
AACR2023 Manual | Phase 1 | 250 | (soecusoufr) = uptrhmldkr qgtsxvejdf (uqdntqqyig ) View more | Positive | 14 Apr 2023 | ||
(HER2 positive breast cancer) | (jcothvgnie) = euwjucyfux hhaknrwdco (dezvtawmow, 72.9 - 88.3) |