Izalontamab brengitecan
Izalontamab brengitecan is the first bispecific ADC to succeed in a phase 3 trial, hitting two growth receptors at once in triple-negative breast cancer.
EGFR×HER3 bispecific ADC from SystImmune (Sichuan Biokin), partnered with Bristol Myers Squibb (2023, up to $8.4B). Phase 3 BL-B01D1-307 in previously treated locally advanced/metastatic TNBC met PFS and OS at interim analysis (announced 26 February 2026; presented ASCO 2026). Also positive in oesophageal squamous cell carcinoma. IZABRIGHT-Breast01 (first-line TNBC, PD-1 ineligible) and trials in NSCLC (EGFR-mutant, post-TKI), urothelial, nasopharyngeal, and SCLC are ongoing. Haematologic toxicity is the main limitation.
Iza-bren (Ed-04) carries a camptothecin-derived TOP1 inhibitor; exatecan shown as the class representative.
1.Antibody binds EGFR and HER3 (bispecific) on the tumour cell surface
- Route
- IV infusion
- Schedule
- 2.5 mg/kg on days 1 and 8 of each 21-day cycle (phase 3 TNBC regimen)
- Monitoring
- Blood counts (neutropenia, anaemia, thrombocytopenia), stomatitis, ILD symptoms
Source: clinicaltrials.gov/study/NCT06382142. Doses are for orientation; the current label governs.
Compare all products across the US, EU, UK, Japan, China and Australia →
| Adverse event |
|---|
| Neutropenia |
| Anaemia |
| Thrombocytopenia |
| Stomatitis |
| Nausea |
Haematologic toxicity is the main limitation in phase 1-3 reports; rates per ASCO 2026 presentation. Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Investigational; BMS filing expected after BL-B01D1-307 | not disclosed | — |
| China | NMPA filings under review (2026) | not disclosed | — |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
Trials
topRecruiting now (live from ClinicalTrials.gov)
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Landmark trials in OnCo
Latest papers
topQuery for this drug: (TITLE:"Izalontamab brengitecan" OR ABSTRACT:"Izalontamab brengitecan" OR TITLE:"iza-bren" OR ABSTRACT:"iza-bren" OR TITLE:"BL-B01D1" OR ABSTRACT:"BL-B01D1") 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 Izalontamab brengitecan, not a curated reading list.