# Izalontamab brengitecan

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

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-09-04
- Code: iza-bren, BL-B01D1
- Modality: Bispecific ADC
- Mechanism: Dual EGFR/HER3 binding drives internalisation across heterogeneous tumours; TOP1 payload with bystander effect.
- Payload: Ed-04 (camptothecin-derived TOP1 inhibitor), DAR ~8
- Linker: Cleavable
- Dosing: IV infusion; 2.5 mg/kg on days 1 and 8 of each 21-day cycle (phase 3 TNBC regimen)

## Sources

- OncLive report: https://www.onclive.com/view/iza-bren-yields-pfs-and-os-benefits-vs-chemo-in-previously-treated-advanced-tnbc

## Connected records

- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/), [EGFR-mutated non-small-cell lung cancer](https://onco.cc/cancers/egfr-mutant-nsclc/), [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/), [Bispecific ADC](https://onco.cc/technologies/bispecific-adc/)
- targets: [EGFR](https://onco.cc/targets/egfr/), [HER3](https://onco.cc/targets/her3/)
- companies: [Bristol Myers Squibb](https://onco.cc/companies/bms/), [SystImmune / Sichuan Biokin](https://onco.cc/companies/systimmune/)
- terms: [Exatecan (and derivatives)](https://onco.cc/terms/exatecan/), [Hydrophilic next-generation linkers (TMALIN, Dolaflexin, sulfonyl-pyrimidine, PEG-containing)](https://onco.cc/terms/hydrophilic-next-gen/), [Topoisomerase-I inhibitor payloads](https://onco.cc/terms/topoisomerase-i-payloads/)
- trials: [A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Pa](https://onco.cc/trials/nct07502300/), [A Study Comparing BL-B01D1 in Combination With Osimertinib Versus Osimertinib Alone in Patients With Locally Advanced, Unresectable EGFR-mutated Non-s](https://onco.cc/trials/nct07640789/), [A Study Comparing BL-B01D1 in Combination With PD-1/VEGF Bispecific Antibody Versus Chemotherapy in Combination With PD-1/VEGF Bispecific Antibody in First-line](https://onco.cc/trials/nct07739199/), [A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU](https://onco.cc/trials/nct06382129/), [A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma(PANKU-NPC01)](https://onco.cc/trials/nct06118333/), [A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer(PANKU-Lung01)](https://onco.cc/trials/nct06382116/), [A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANK](https://onco.cc/trials/nct06994195/), [A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03)](https://onco.cc/trials/nct06500026/), [A Study Evaluating BL-B01D1 in Combination With a PD-1/VEGF Bispecific Antibody Versus Tislelizumab Plus Platinum-doublet Chemotherapy as First-line Treatment f](https://onco.cc/trials/nct07739186/), [A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer](https://onco.cc/trials/nct07054567/), [A Study of BL-B01D1 and BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung ](https://onco.cc/trials/nct05880706/), [A Study of BL-B01D1 Combined With Glecirasib in Patients With KRAS G12C-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer](https://onco.cc/trials/nct07827261/), [A Study of BL-B01D1 in Combination With Osimertinib as Perioperative Therapy in Patients With EGFR-mutated Resectable Non-small Cell Lung Cancer(PANKU](https://onco.cc/trials/nct07642024/), [A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer](https://onco.cc/trials/nct06498986/), [A Study of BL-B01D1 in Combination With Osimertinib Versus Osimertinib as First-Line Treatment in Patients With EGFR-Mutated Locally Advanced or Metas](https://onco.cc/trials/nct06838273/), [A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma](https://onco.cc/trials/nct06787664/), [A Study of BL-B01D1 Plus an Anti-PD-1 Antibody Versus Nab-paclitaxel Plus an Anti-PD-1 Antibody in Patients With Previously Untreated, Locally Advanced, Inopera](https://onco.cc/trials/nct07729956/), [A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Extensive Stage Small Cell Lung Cancer](https://onco.cc/trials/nct05924841/), [A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies](https://onco.cc/trials/nct05990803/), [A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumor](https://onco.cc/trials/nct06006169/), [A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer](https://onco.cc/trials/nct06437509/), [A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and ](https://onco.cc/trials/nct06475300/), [A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors](https://onco.cc/trials/nct06437522/), [A Study of SI-B003 and BL-B01D1+SI-B003 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other](https://onco.cc/trials/nct05956587/), [A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric ](https://onco.cc/trials/nct06008054/), [BL-B01D1-307](https://onco.cc/trials/bl-b01d1-307/), [IZABRIGHT-Breast01](https://onco.cc/trials/izabright-breast01/), [PANKU-Esophagus01 (BL-B01D1-305)](https://onco.cc/trials/panku-esophagus01/), [Protein-Matched ADC or PDC Umbrella Trial in Advanced Pancreatic and Breast Cancer](https://onco.cc/trials/nct07825753/), [Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based C](https://onco.cc/trials/nct07680790/), [Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy](https://onco.cc/trials/nct07100080/)
- roadmaps: [ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs](https://onco.cc/roadmaps/adc-generations/), [Triple-negative breast cancer roadmap: from a remainder defined by three negative tests to immunotherapy, antibody-drug conjugates and the residual disease problem](https://onco.cc/roadmaps/tnbc-roadmap/)
- institutions: [Sun Yat-sen University Cancer Center](https://onco.cc/institutions/sysucc/)
- pairings: [EGFR TKI → ADC on progression](https://onco.cc/pairings/tki-then-adc-lung/)
- people: [Li Zhang](https://onco.cc/people/zhang-li-sysucc/)
- ideas: [Two-target antibody drugs to close the antigen escape route](https://onco.cc/ideas/idea-bio1-dual-antigen-adc-escape/)

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