# BL-B01D1-307

Source: https://onco.cc/trials/bl-b01d1-307/  
OnCo record `bl-b01d1-307` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The first phase 3 win for a bispecific ADC, in triple-negative breast cancer, announced February 2026.

## Summary

BL-B01D1-307, trial NCT06382142 sponsored by SystImmune and Bristol Myers Squibb and announced on 26 February 2026, delivered the first phase 3 win for a bispecific antibody-drug conjugate, izalontamab brengitecan, in previously treated locally advanced or metastatic triple-negative breast cancer. It randomised 418 patients in China to the EGFR by HER3 conjugate or chemotherapy and met its primary progression-free survival endpoint by blinded review and its interim overall survival endpoint with statistically significant and clinically meaningful improvements, with full data at ASCO 2026 and a parallel positive phase 3 in oesophageal squamous cell carcinoma. It has not been replicated outside China, and the global first-line IZABRIGHT-Breast01 trial will show whether the result travels, which is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-04
- Registry id: NCT06382142
- Phase: 3
- Setting: Previously treated locally advanced or metastatic TNBC: izalontamab brengitecan vs chemotherapy
- Sponsor: SystImmune / BMS
- Enrolled: 418
- Result: PFS and OS significantly improved at interim analysis (numbers presented ASCO 2026).
- Outcomes: Progression-free survival (BICR): Izalontamab brengitecan 8.5 months vs Chemotherapy (TPC) 3.1 months, HR 0.29; Overall survival (interim, median follow-up 11 months): Izalontamab brengitecan 15.9 months vs Chemotherapy (TPC) 12.5 months, HR 0.6; Confirmed objective response rate (BICR): Izalontamab brengitecan 51.7% vs Chemotherapy (TPC) 20.5%
- Replication: Single Chinese phase 3 with an interim OS analysis; a parallel positive phase 3 in oesophageal squamous cell carcinoma supports the drug, and the global IZABRIGHT-Breast01 trial will test the first-line setting. Not yet replicated outside China.

## Sources

- ClinicalTrials.gov NCT06382142: https://clinicaltrials.gov/study/NCT06382142
- Targeted Oncology report: https://www.targetedonc.com/view/iza-bren-meets-pfs-and-os-end-points-in-phase-3-tnbc-trial

## Connected records

- collections: [Targeted Oncology](https://onco.cc/collections/src-targeted-oncology/)
- cancers: [Metastatic triple-negative breast cancer](https://onco.cc/cancers/tnbc-metastatic/), [Oesophageal cancer](https://onco.cc/cancers/esophageal/), [Triple-negative breast cancer (TNBC)](https://onco.cc/cancers/tnbc/)
- technologies: [Bispecific ADC](https://onco.cc/technologies/bispecific-adc/)
- drugs: [Izalontamab brengitecan](https://onco.cc/drugs/izalontamab-brengitecan/)
- trials: [PANKU-Esophagus01 (BL-B01D1-305)](https://onco.cc/trials/panku-esophagus01/)
- roadmaps: [ADC roadmap: from Mylotarg to bispecific and dual-payload ADCs](https://onco.cc/roadmaps/adc-generations/), [TNBC roadmap: from 'nothing to target' to ADC + immunotherapy first line](https://onco.cc/roadmaps/tnbc-history/), [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/)

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