OnCo
drugsProductPhase 3

Trastuzumab brengitecan

SystImmune's HER2 ADC, sharing its payload with iza-bren, now in a 1,450-patient trial to replace Kadcyla after surgery.

Phase 1 (ESMO 2025; Lancet-family 2026): responses in HER2-positive and HER2-low breast cancer. Phase 3 versus T-DM1 in residual disease after neoadjuvant therapy (~1,450 patients) enrolling in China; the same setting DESTINY-Breast05 has just redefined with T-DXd.

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Payload class: exatecan
PubChem

Trastuzumab brengitecan (BL-M07D1) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.

How it works, step by step · animated schematic, not to scale
Antibody-drug conjugate (ADC)
Modality
ADC
Mechanism
Anti-HER2 antibody with cleavable linker and Ed-04 payload (bystander-capable).
Brand / code
BL-M07D1, T-Bren
Payload
Ed-04 (camptothecin-derived TOP1 inhibitor), DAR ~8
Linker
Cathepsin B-cleavable

Regulatory

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  1. Feb 2025Filing / dealChina

    Phase 3 vs T-DM1 in residual disease registered (NCT06830889) source

Trials

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Recruiting now (live from ClinicalTrials.gov)

Recruiting trials near you · live from ClinicalTrials.gov
Trastuzumab brengitecan
intervention: Trastuzumab brengitecan
Open on ClinicalTrials.gov →

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Landmark trials in OnCo

Latest papers

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Literature trend2 papers in the last 12 monthsHow this is computed
Latest papers · live from Europe PMC
Open in Europe PMC

Query for this drug: (TITLE:"Trastuzumab brengitecan" OR ABSTRACT:"Trastuzumab brengitecan" OR TITLE:"BL-M07D1" OR ABSTRACT:"BL-M07D1" OR TITLE:"T-Bren" OR ABSTRACT:"T-Bren") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Trastuzumab brengitecan, not a curated reading list.

Connected

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