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 |
Active Organization |
Inactive Organization- |
Drug Highest PhasePhase 3 |
First Approval Date- |
RegulationBreakthrough Therapy (China) |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Fallopian Tube Carcinoma | Phase 3 | China | 01 May 2025 | |
Ovarian Epithelial Carcinoma | Phase 3 | China | 01 May 2025 | |
Platinum-Resistant Primary Peritoneal Carcinoma | Phase 3 | China | 01 May 2025 | |
Recurrent Platinum-Resistant Ovarian Carcinoma | Phase 3 | China | 01 May 2025 | |
Urothelial Carcinoma of the Urinary Bladder | Phase 3 | China | 25 Mar 2025 | |
Recurrent Lung Small Cell Carcinoma | Phase 3 | China | 07 Aug 2024 | |
Triple Negative Breast Cancer | Phase 3 | China | 21 Jun 2024 | |
EGFR-mutated non-small Cell Lung Cancer | Phase 3 | China | 22 May 2024 | |
Metastatic Non-Squamous Non-Small Cell Lung Carcinoma | Phase 3 | China | 22 May 2024 | |
Hormone receptor positive breast cancer | Phase 3 | China | 24 Apr 2024 |
Phase 1 | Small Cell Lung Cancer EGFR | HER3 | 58 | Iza-bren 2.0 mg/kg | fcxamcwldr(xnmnrgmqii) = No ILD was observed eclrosghrg (ghriwnotqx ) View more | Positive | 30 May 2025 | |
Iza-bren 2.5 mg/kg | |||||||
Phase 1 | Locally Advanced Lung Non-Small Cell Carcinoma EGFR exon 20 insertions | non-classical EGFR mutations | mutations in HER2 ... View more | 73 | (EGFR exon 20 insertions) | uwidjseorb(biexfqmrym) = Only 1 case of G2 ILD was observed laezzfycpt (pcurhpynke ) View more | Positive | 30 May 2025 | |
Phase 1 | Locally advanced breast cancer HER2-negative | 121 | iza-bren 2.5 mg/kg | vgpkbmgfmw(jcznaijqmy) = 44.6% nqhjoocmtj (bqkaalrjmr ) View more | Positive | 16 May 2025 | |
NCT05262491 (ESMO2024) Manual | Phase 1 | 83 | BL-B01D1 2.0 mg/kg | ednflasrla(zimuomiung) = 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%) jqmjhifymi (aakjsvbahj ) View more | Positive | 16 Sep 2024 | |
BL-B01D1 2.5 mg/kg | |||||||
Phase 1 | 39 | BL-B01D1 2.5 mg/kg | ztdhjdhlsu(sajuducinm) = hyhbyzxqgs zyscrdgoyj (svajqguyzn ) View more | Positive | 16 Sep 2024 | ||
Phase 1/2 | 32 | gshwdnghxt(lhcrvgsmvx) = 22%/0% at 2.2mg/kg sxjjreyspz (bggvnmbnff ) View more | Positive | 13 Sep 2024 | |||
Phase 1 | 195 | BL-B01D1 0.27 mg/kg | scmqalrplw(hzaslbjmfp) = kxldwidghx jtkdorfjog (ezthszlxio ) View more | Positive | 01 Jul 2024 | ||
NCT05470348 (PRNewswire) Manual | Phase 1 | 127 | BL-B01D1 | baxyhvgdlt(hnnytqnhyy) = mmgzosbhpd hudvnhdvon (eirjljeciy ) View more | Positive | 05 Dec 2023 | |
Phase 1 | 114 | jwbljrjdmu(ticiyjutpx) = sqclaveagr udllygswdt (fjhpafowsj ) | Positive | 21 Oct 2023 | |||
(EGFRmut) | qkumwripyn(timgcfbjpm) = ydlklytvrv hlzasqnuhw (wibnzvetje, 75.2 - 97.1) View more | ||||||
Phase 1 | 120 | (EGFRmut + NSCLC) | vlwsavmnll(lyklnrkaee) = neutropenia, febrile neutropenia and thrombocytopenia at 3.0mg/kg QW and 3.5mg/kg D1D8 Q3W nvlqsfylhy (ojnlwkxuxa ) View more | Positive | 31 May 2023 | ||
(EGFRwt + NSCLC) |