{"entity":{"id":"trastuzumab-brengitecan","kind":"drug","name":"Trastuzumab brengitecan","aka":[],"tldr":"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.","status":"phase-3","asOf":"2026-09-07","links":[{"label":"ClinicalTrials.gov NCT04622319 (DESTINY-Breast05)","url":"https://clinicaltrials.gov/study/NCT04622319"}],"tags":[],"related":[],"cancers":["breast-her2-positive"],"sections":[],"technologies":["adc","topoisomerase-inhibitors"],"targets":["her2"],"drugs":[],"companies":["systimmune"],"institutions":[],"pathways":[],"terms":[],"trials":["destiny-breast05","nct07518173","nct06830889","nct06316531","nct07178795","nct06891833","nct06114511","nct06445400","nct07264816"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"code":"BL-M07D1, T-Bren","modality":"ADC","payload":"Ed-04 (camptothecin-derived TOP1 inhibitor), DAR ~8","linker":"Cathepsin B-cleavable","mechanism":"Anti-HER2 antibody with cleavable linker and Ed-04 payload (bystander-capable).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[{"date":"2025-02","type":"filing","region":"China","note":"Phase 3 vs T-DM1 in residual disease registered (NCT06830889)","source":"https://clinicaltrials.gov/study/NCT06830889"}]},"route":"/drugs/trastuzumab-brengitecan/","neighbours":{"cancer":[{"id":"breast-her2-positive","kind":"cancer","name":"HER2-positive breast cancer","route":"/cancers/breast-her2-positive/"}],"technology":[{"id":"adc","kind":"technology","name":"Antibody-drug conjugate (ADC)","route":"/technologies/adc/"},{"id":"topoisomerase-inhibitors","kind":"technology","name":"Topoisomerase-I inhibitors (and ADC payloads)","route":"/technologies/topoisomerase-inhibitors/"}],"target":[{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"systimmune","kind":"company","name":"SystImmune / Sichuan Biokin","route":"/companies/systimmune/"}],"trial":[{"id":"nct07730489","kind":"trial","name":"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","route":"/trials/nct07730489/"},{"id":"nct06316531","kind":"trial","name":"A Study Comparing BL-M07D1 With T-DM1 in Patients With Unresectable Locally Advanced or Metastatic HER2-positive Breast Cancer","route":"/trials/nct06316531/"},{"id":"nct07518173","kind":"trial","name":"A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or M","route":"/trials/nct07518173/"},{"id":"nct07264816","kind":"trial","name":"A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NS","route":"/trials/nct07264816/"},{"id":"nct06114511","kind":"trial","name":"A Study of BL-M07D1 in Patients With HER2-mutated, Locally Advanced or Metastatic Non-small-cell Lung Cancer","route":"/trials/nct06114511/"},{"id":"nct06830889","kind":"trial","name":"A Study of BL-M07D1 Versus T-DM1 in the Adjuvant Treatment of HER2-positive Breast Cancer With Residual Invasive Cancer After Neoadjuvant Therapy","route":"/trials/nct06830889/"},{"id":"nct07178795","kind":"trial","name":"A Study of BL-M07D1 vs Pembrolizumab-platinum Chemotherapy in First-line Treatment of HER2-mutant Advanced or Metastatic Non-squamous NSCLC","route":"/trials/nct07178795/"},{"id":"nct06891833","kind":"trial","name":"A Study of BL-M07D1 With or Without Pertuzumab Versus Docetaxel + Carboplatin + Trastuzumab + Pertuzumab in Neoadjuvant Therapy for HER2-Positive Brea","route":"/trials/nct06891833/"},{"id":"nct06445400","kind":"trial","name":"A Study of BL-M07D1, BL-M07D1+Pertuzumab and BL-M07D1+Pertuzumab+Docetaxel in Patients With Unresectable Locally Advanced or Metastatic HER2-positive ","route":"/trials/nct06445400/"},{"id":"destiny-breast05","kind":"trial","name":"DESTINY-Breast05","route":"/trials/destiny-breast05/"}]}}