Drug Type Antibody drug conjugate (ADC) |
Synonyms Zalontamab brengitecan, BL B01D1, BL-B01D1 + [2] |
Target |
Action antagonists, inhibitors |
Mechanism EGFR antagonists(Epidermal growth factor receptor erbB1 antagonists), HER3 antagonists(Receptor tyrosine-protein kinase erbB-3 antagonists), TOP1 inhibitors(DNA topoisomerase I inhibitors) |
Therapeutic Areas |
Inactive Indication- |
Originator Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Advanced Urothelial Carcinoma | Phase 3 | United States | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Japan | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Argentina | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Australia | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Austria | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Belgium | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Brazil | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Canada | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | France | 22 Oct 2025 | |
Advanced Urothelial Carcinoma | Phase 3 | Germany | 22 Oct 2025 |
NCT05262491 (Pubmed) Manual | Phase 1 | 82 | ftjnquxkbm(kmnamwcpzz) = established at 2.5 mg kg-1 D1D8 Q3W hfjyogstjw (lywhvhuxjz ) View more | Positive | 10 Jul 2025 | ||
Phase 1 | Non-Small Cell Lung Cancer EGFR exon 20 insertions | non-classical EGFR mutations | mutations in HER2 ... View more | 73 | (EGFR exon 20 insertions) | ledpfgycfh(wwwwzrtkop) = Only 1 case of G2 ILD was observed ienkyfroxt (xkecxbzrdl ) View more | Positive | 30 May 2025 | |
Phase 1 | Small Cell Lung Cancer EGFR | HER3 | 58 | Iza-bren 2.0 mg/kg | qhlupozmmp(lfptajcogu) = No ILD was observed iqesfwzjri (pefrgekqql ) View more | Positive | 30 May 2025 | |
Iza-bren 2.5 mg/kg | |||||||
Phase 1 | Locally advanced breast cancer HER2-negative | 121 | iza-bren 2.5 mg/kg | aitnlqzjks(rhbmqdadvt) = 44.6% mniuzjufrf (htjacogcrg ) View more | Positive | 16 May 2025 | |
NCT05262491 (ESMO2024) Manual | Phase 1 | 83 | BL-B01D1 2.0 mg/kg | thrqqltxfz(mgprarwkfw) = The incidence of ≥ G3 TRAEs at 2.5 mg/kg was 53%, and the most common ≥G3 TRAEs were anemia (25%), leukopenia (18%), thrombocytopenia (18%), neutropenia (15%), lymphocyte count decreased (15%) khogolwjpz (vpuwclnldo ) View more | Positive | 16 Sep 2024 | |
BL-B01D1 2.5 mg/kg | |||||||
Phase 1 | 39 | BL-B01D1 2.5 mg/kg | wnsuxqbdod(cwbdzizpyw) = hcckeibibs kpcyrusfwo (cxgvhdwhro ) View more | Positive | 16 Sep 2024 | ||
Phase 1/2 | 32 | xaxijbmaby(rkihrhmnps) = 22%/0% at 2.2mg/kg qsayofmunx (tcxlmvtzfr ) View more | Positive | 13 Sep 2024 | |||
Phase 1 | 195 | BL-B01D1 0.27 mg/kg | sbighdonva(mjcsftdimt) = boaabkoean nheoszpboj (vuahozzbdm ) View more | Positive | 01 Jul 2024 | ||
NCT05470348 (PRNewswire) Manual | Phase 1 | 127 | BL-B01D1 | xczsdypabo(lhfdmwokhk) = mgpyjmynkj yhshnxmyst (eihlepzgtp ) View more | Positive | 05 Dec 2023 | |
Phase 1 | 114 | xsjbengmzj(ucnxajbbua) = zbbekxusuh ppryixnbzp (coykywdxbd ) | Positive | 21 Oct 2023 | |||
(EGFRmut) | wqruiushho(xndrzsdnjj) = ilchpepeng aaycrdcost (oafqjmzwco, 75.2 - 97.1) View more |