Drugs / BL-B01D1

Trials 53

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT05983432 Aug 2023 → Apr 2030 expected cervical cancer, endometrial cancer, esophageal cancer, head and neck squamous cell carcinoma +6 SystImmune Inc. Recruiting No outcome recorded
Phase 1 NCT05470348 Aug 2022 → Dec 2026 expected breast cancer Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT05393427 Feb 2022 → Dec 2025 overdue malignant urinary system neoplasm Sichuan Baili Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 1 NCT05262491 Feb 2022 → Dec 2026 expected digestive system neoplasm Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1 NCT05194982 Nov 2021 → Dec 2026 expected — Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT07307053 Jan 2026 → Jan 2029 expected high grade malignant neoplasm, metastatic neoplasm Cancer Institute and Hospital, Chinese Academy of Medical Sciences Not yet recruiting No outcome recorded
Phase 1/2 NCT06618287 Feb 2025 → Feb 2031 expected breast cancer, lung cancer Bristol-Myers Squibb Recruiting No outcome recorded
Phase 1/2 NCT05803018 Jun 2023 → Dec 2026 expected female reproductive organ cancer Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 226 trials
Phase 2 NCT07825753 Sep 2026 → Sep 2027 expected breast cancer, pancreatic adenocarcinoma Fudan University Not yet recruiting No outcome recorded
Phase 2 NCT07797881 Sep 2026 → Dec 2030 expected nasopharyngeal carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT07827261 Sep 2026 → Dec 2028 expected non-small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2 NCT06855771 Sep 2025 → Dec 2028 expected non-small cell lung carcinoma Bristol-Myers Squibb Recruiting No outcome recorded
Phase 2 NCT07054567 Aug 2025 → May 2027 expected cervical cancer, endometrial cancer Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06962787 Jul 2025 → May 2027 expected kidney cancer Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06951464 Jun 2025 → May 2027 expected non-small cell lung carcinoma Sichuan University Recruiting No outcome recorded
Phase 2 NCT06986785 Jun 2025 → May 2027 expected hepatocellular carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06978114 Jun 2025 → May 2027 expected biliary tract cancer Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2 NCT06787664 Jan 2025 → Jun 2027 expected chordoma Sichuan Baili Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded
Phase 2/33 trials
Phase 2/3 NCT07554456 Jun 2026 → Dec 2028 expected esophageal squamous cell carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 2/3 NCT07642024 Jun 2026 → Dec 2032 expected non-small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 2/3 NCT07641855 Jun 2026 → Dec 2028 expected castration-resistant prostate carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 316 trials · 3 met primary
Phase 3 NCT07729956 Sep 2026 → Dec 2029 expected triple-negative breast carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07783321 Sep 2026 → Dec 2033 expected nasopharyngeal carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07640789 Aug 2026 → Dec 2030 expected non-small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT07582315 Jul 2026 → Dec 2028 expected biliary tract cancer Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07648914 Jun 2026 → Dec 2028 expected breast cancer Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT07502300 Apr 2026 → Dec 2029 expected small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Not yet recruiting No outcome recorded
Phase 3 NCT06994195 Aug 2025 → Jun 2027 expected fallopian tube cancer, malignant epithelial tumor of ovary, primary peritoneal carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06857175 Mar 2025 → Jun 2027 expected urothelial carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06838273 Feb 2025 → Dec 2028 expected non-small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Recruiting No outcome recorded
Phase 3 NCT06500026 Aug 2024 → Dec 2026 expected small cell lung carcinoma Sichuan Baili Pharmaceutical Co., Ltd. Active not recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 48

DateIssuerRelease
2026-09-28 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于宜泽康?(伦康依隆妥单抗,BL-B01D1/iza-bren)用于既往经含铂化疗治疗失败的复发性或转移性胆道癌患者纳入突破性治疗品种名单的公告 cninfo.com.cn ↗
2026-09-22 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于宜泽康?(伦康依隆妥单抗,BL-B01D1/iza-bren)联合PD-1单抗治疗一线局部复发不可切除或转移性三阴性乳腺癌患者纳入突破性治疗品种名单的公告 cninfo.com.cn ↗
2026-09-12 SystImmune Inc. Results 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 ↗
New global Phase 1 data from a randomized dose-expansion cohort of iza-bren in previously treated EGFR-mutated metastatic NSCLC demonstrate promising antitumor activity and a tolerable safety profile, supporting selection of 2.5 mg/kg D1D8 Q3W as the recommended Phase 3 dose
2026-08-26 Sichuan Biokin Pharmaceutical Co., Ltd. Results 四川百利天恒药业股份有限公司自愿披露关于宜泽康?(伦康依隆妥单抗,BL-B01D1/iza-bren)用于局部晚期、复发或转移性HR+HER2-乳腺癌的III期临床试验的期中分析达到主要终点的公告 cninfo.com.cn ↗
2026-08-18 Sichuan Biokin Pharmaceutical Co., Ltd. Results 四川百利天恒药业股份有限公司自愿披露关于伦康依隆妥单抗/宜泽康(BL-B01D1/iza-bren)用于局部晚期或转移性非小细胞肺癌的III期临床试验的期中分析达到主要终点的公告 cninfo.com.cn ↗
2026-07-31 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于注射用BL-B01D1(皮下注射)治疗晚期实体瘤获得药物临床试验批准通知书的公告 cninfo.com.cn ↗
2026-07-17 SystImmune Inc. Regulatory SystImmune Announces Second Approval of Iza-bren in China for the Treatment of Recurrent or Metastatic Esophageal Squamous Cell Carcinoma systimmune.com ↗
SystImmune Inc. (SystImmune) today announced that its parent company, Sichuan Biokin Pharmaceutical Co., Ltd. (Biokin), has received regulatory approval from China's National Medical Products Administration (NMPA) for iza-bren (izalontamab brengitecan) for the treatment of adult patients with recurrent or metastatic esophageal squamous cell carcinoma (ESCC) whose disease has progressed following prior platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy.
2026-07-17 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于伦康依隆妥单抗/宜泽康(BL-B01D1/iza-bren)食管癌适应症上市申请获得批准的公告 cninfo.com.cn ↗
2026-06-23 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于伦康依隆妥单抗(BL-B01D1/iza-bren)获批上市的公告 cninfo.com.cn ↗
2026-06-22 SystImmune Inc. Regulatory SystImmune Announces First Approval of Iza-bren for the Treatment of Recurrent or Metastatic Nasopharyngeal Carcinoma in China systimmune.com ↗
This approval marks the first regulatory approval for iza-bren and represents a significant milestone in the development of SystImmune's proprietary bispecific antibody-drug conjugate platform.
2026-06-15 Sichuan Biokin Pharmaceutical Co., Ltd. Regulatory 四川百利天恒药业股份有限公司自愿披露关于iza-bren(EGFR×HER3双抗ADC)用于治疗局部晚期或转移性三阴乳腺癌的药品上市申请获得受理的公告 cninfo.com.cn ↗
2026-06-02 SystImmune Inc. Results 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 ↗
Iza-bren has now shown clinical benefit in three Phase 3 trials, underscoring its broad therapeutic potential.

All press releases naming this drug 64 releases

DateIssuerRelease

Evidence & citations 6 cited values

Every value below carries the sentence it was read from. 55 sources stand behind the page.

FieldValueCited text
Known as BL-B01D1 “Izalontamab brengitecan (iza-bren; BL-B01D1) is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, covalently linked to a topoisomerase I inhibitor payload.” NCT07825753 ↗
50

NCT07054567 ↗

NCT06475300 ↗

NCT06382142 ↗

NCT05956587 ↗

NCT06382129 ↗

NCT07648914 ↗

NCT06598787 ↗

NCT05262491 ↗

NCT05470348 ↗

NCT06008054 ↗

Show 40 more sources

Known as BMS-986507 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06618287 ↗
Known as iza-bren “Izalontamab brengitecan (iza-bren; BL-B01D1) is a bispecific antibody-drug conjugate (ADC) targeting both EGFR and HER3, covalently linked to a topoisomerase I inhibitor payload.” NCT07825753 ↗
Known as Izalontamab Brengitecan ClinicalTrials.gov intervention name — accepted as the source's own label NCT06855771 ↗
1

NCT07825753 ↗

Route Intravenous “patients received intravenous BL-B01D1” PMID 38823410 ↗ May 2024
Target EGFR “targeting EGFR and human epidermal growth factor receptor 3 (HER3)” PMID 41611210 ↗ Jan 2026