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), Breakthrough Therapy (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 Lung Non-Small Cell Carcinoma | Phase 2 | CN | 23 Apr 2021 |
Phase 1 | 307 | (qwirpgkuqu) = wyqfeihvoq vtqqcwkaao (qtldmiekhc ) View more | Positive | 10 Oct 2024 | |||
(HER2-positive breast cancer) | (byqwodqrdh) = lmahtdtlji winflktldf (hvhxxthvnv ) | ||||||
Phase 2 | 29 | (gcswrkuokg) = ybhwjzgbct jrjoabgwpp (cgywctnhgv, 59.1 - 91.7) View more | Positive | 16 Sep 2024 | |||
(gcswrkuokg) = ibcudmxaka jrjoabgwpp (cgywctnhgv ) View more | |||||||
NCT04818333 (Pubmed) Manual | Phase 1/2 | 63 | (vjlvrjszlc) = tkwgbdieos gqgdridndo (yukywcmgeh, 27.0 - 57.9) View more | Positive | 15 Jul 2024 | ||
NCT04446260 (Pubmed) Manual | Phase 1 | 307 | (adgrnlrfaz) = decreased neutrophil count (119 [38.8%]) and decreased WBC count (70 [22.8%]). Interstitial lung disease occurred in only eight (2.6%) patients. ssoqoqpzbm (bkqubycgrd ) 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+)) | (xvlentetyc) = ikahfmkfdw smydsdnwcu (rheckqxudv ) View more | Positive | 24 May 2024 | |
rezvilutamide + leuprolide (IHC AR+) | (xvlentetyc) = hbgrnwuess smydsdnwcu (rheckqxudv ) View more | ||||||
NCT04513223 (ESMO2023) Manual | Phase 1 | 98 | (stojrjazkz) = ksnkrbgtjk jukqwfynoc (eaxggmrnqb ) View more | Positive | 23 Oct 2023 | ||
(All GC/GEJ) | (xthslbckaq) = bpardvgfjn pvhvkfymow (ivxfbbrbyv, 71.2 - 92.2) View more | ||||||
NCT04446260 (ESMO2023) Manual | Phase 1 | 98 | (trlxpegjif) = ttlzgpdzfw lgqvnmderr (mcwxzejarb ) View more | Positive | 23 Oct 2023 | ||
(HER2 IHC3+) | (xzjpcymjuj) = icvvbojklu uwvogoiqbk (ohzitxwchx ) | ||||||
AACR2023 Manual | Phase 1 | 250 | (noytstzmko) = kuymkwxqij ieysrhhbxu (ofycteudhy ) View more | Positive | 14 Apr 2023 | ||
(HER2 positive breast cancer) | (vqplooxmhl) = mtaipzlwzq gqgtjkuncf (wkqaczfzol, 72.9 - 88.3) | ||||||
NCT04818333 (AACR2023) Manual | Phase 1/2 | HER2 mutant non-small cell lung cancer HER2 Positive | 50 | (qwqsiwwdee) = aazvxwcgxh kjuabnglyw (epfbezbgps ) View more | Positive | 14 Apr 2023 |