# Trastuzumab brengitecan

Source: https://onco.cc/drugs/trastuzumab-brengitecan/  
OnCo record `trastuzumab-brengitecan` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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

## Summary

Trastuzumab brengitecan is SystImmune's HER2 antibody-drug conjugate: an anti-HER2 antibody joined through a cleavable linker to the payload Ed-04, which can cross into neighbouring cells (bystander effect) and is shared with the company's iza-bren. Phase 1 data (ESMO 2025; Lancet-family 2026) showed responses in both HER2-positive and HER2-low breast cancer. A phase 3 trial of about 1,450 patients is enrolling in China, comparing it with T-DM1 in patients with residual disease after neoadjuvant therapy (NCT06830889). That is the same setting DESTINY-Breast05 has just redefined with T-DXd (3-year invasive disease-free survival 92.4% versus 83.7%, HR 0.47), so the trial's relevance depends on whether T-DM1 remains a fair comparator. For a newcomer, it is a Chinese HER2 ADC trying to replace Kadcyla after surgery.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-07
- Code: BL-M07D1, T-Bren
- Modality: ADC
- Mechanism: Anti-HER2 antibody with cleavable linker and Ed-04 payload (bystander-capable).
- Payload: Ed-04 (camptothecin-derived TOP1 inhibitor), DAR ~8
- Linker: Cathepsin B-cleavable

## Sources

- ClinicalTrials.gov NCT04622319 (DESTINY-Breast05): https://clinicaltrials.gov/study/NCT04622319

## Connected records

- cancers: [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Topoisomerase-I inhibitors (and ADC payloads)](https://onco.cc/technologies/topoisomerase-inhibitors/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [SystImmune / Sichuan Biokin](https://onco.cc/companies/systimmune/)
- trials: [A Study Comparing BL-M07D1 With Physician's Choice Therapy in Patients With HER2 IHC3+ Advanced Colorectal Cancer Who Failed Prior Treatment With Oxaliplatin, F](https://onco.cc/trials/nct07730489/), [A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer](https://onco.cc/trials/nct06316531/), [A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or M](https://onco.cc/trials/nct07518173/), [A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NS](https://onco.cc/trials/nct07264816/), [A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer](https://onco.cc/trials/nct06114511/), [A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy](https://onco.cc/trials/nct06830889/), [A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC](https://onco.cc/trials/nct07178795/), [A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea](https://onco.cc/trials/nct06891833/), [A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive ](https://onco.cc/trials/nct06445400/), [DESTINY-Breast05](https://onco.cc/trials/destiny-breast05/)

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