Drugs / Iza-bren
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Iza-bren

also known as Izalontamab Brengitecan

targets EGFR

Developed for
non-small cell lung carcinoma · breast neoplasm · urothelial carcinoma
Investigated by
Bristol-Myers Squibb · M.D. Anderson Cancer Center · SystImmune Inc.

Trials 5

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT07382726 Jul 2026 → Dec 2027 expected non-small cell lung carcinoma M.D. Anderson Cancer Center Not yet recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07100080 Nov 2025 → Dec 2028 expected non-small cell lung carcinoma Bristol-Myers Squibb Recruiting No outcome recorded
Phase 2/3 NCT07106762 Sep 2025 → Jan 2029 expected urothelial carcinoma Bristol-Myers Squibb Recruiting No outcome recorded
Phase 2/3 NCT06926868 Sep 2025 → Mar 2028 expected breast neoplasm Bristol-Myers Squibb Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT07680790 Sep 2026 → Dec 2031 expected non-small cell lung carcinoma Bristol-Myers Squibb Not yet recruiting No outcome recorded

Press releases naming this drug 19 releases

DateIssuerRelease
2026-09-12 SystImmune Inc. SystImmune, Inc. to Present New Global Data on Iza-bren (izalontamab brengitecan) in EGFR-mutated Non-Small Cell Lung Cancer at WCLC Congress 2026 systimmune.com ↗
2026-07-17 SystImmune Inc. SystImmune Announces Second Approval of Iza-bren in China for the Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma systimmune.com ↗
2026-06-22 SystImmune Inc. SystImmune Announces First Approval of Iza-bren for the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma in China systimmune.com ↗
2026-06-02 SystImmune Inc. Izalontamab Brengitecan (Iza-Bren) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Patients with Triple-Negative Breast Cancer and Esophageal Squamous Cell Carcinoma systimmune.com ↗
2026-06-02 Bristol-Myers Squibb Izalontamab Brengitecan (Iza-Bren) Demonstrates Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Patients with Triple-Negative Breast Cancer and Esophageal Squamous Cell Carcinoma bms.com ↗
2026-05-21 SystImmune Inc. New Clinical Data for Izalontamab Brengitecan and Novel ADC Pipeline to be Presented at ASCO 2026 systimmune.com ↗
2026-03-18 SystImmune Inc. SystImmune, Inc. to Present New iza-bren (izalontamab brengitecan) Data in Extensive Stage Small Cell Lung Cancer at ELCC 2026 systimmune.com ↗
2026-02-26 SystImmune Inc. SystImmune and Bristol Myers Squibb Highlight Positive Phase III Interim Topline Results for izalontamab brengitecan (Iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer systimmune.com ↗
2026-02-26 Bristol-Myers Squibb SystImmune and Bristol Myers Squibb Highlight Positive Phase III Interim Topline Results for izalontamab brengitecan (Iza-bren) in Previously Treated Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer bms.com ↗
2025-10-18 SystImmune Inc. SystImmune Announces iza-bren Meets One of the Dual Primary Endpoints in the BL-B01D1-303 Trial in Recurrent or Metastatic NPC Patients with Results Presented as a Late-Breaking Oral Presentation at ESMO systimmune.com ↗
2025-10-17 Bristol-Myers Squibb SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren, an EGFR x HER3 Bispecific Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors at ESMO 2025 bms.com ↗
2025-10-16 SystImmune Inc. SystImmune, Inc. and Bristol Myers Squibb Announce First Global Phase I Results of Iza-bren, an EGFR x HER3 Bispecific Antibody-Drug Conjugate, in Patients with Advanced Solid Tumors at ESMO 2025 systimmune.com ↗

Evidence & citations 4 cited values

Every value below carries the sentence it was read from. 5 sources stand behind the page.

FieldValueCited text
Known as iza-bren “This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't...” NCT07382726 ↗
5

NCT07106762 ↗

NCT06926868 ↗

NCT07382726 ↗

NCT07680790 ↗

NCT07100080 ↗

Known as Izalontamab Brengitecan “This research is being done to test a combination of two drugs, Izalontamab Brengitecan (iza-bren) and Adagrasib, in patients with advanced KRAS G12C-mutant NSCLC that hasn't...” NCT07382726 ↗
Route Intravenous “Given by IV” NCT07382726 ↗
Target EGFR “a bi-specific antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload” NCT06926868 ↗