izalontamab brengitecan (BL-B01D1) / Biokin Pharma, BMS - LARVOL DELTA

A Study of BL-B01D1 Combined With Lenvatinib in Patients With Advanced Hepatocellular Carcinoma (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of BL-B01D1 + Axitinib Without or With Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov) - P2 | N=120 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

Phase II Study of Iza-Bren (BL-B01D1) Combo With Osimertinib in EGFR Mutated Locally Advanced or Metastatic NSCLC Patients (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • P2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

Phase I/II Study of Iza-Bren (BL-B01D1) as Monotherapy in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC (IASLC-WCLC 2025) - "Abstract is embargoed at this time."

Clinical • Metastases • Monotherapy • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor • EGFR

SystImmune, Inc. to Present New iza-bren (izalontamab brengitecan) Data in Non-Small Cell Lung Cancer at WCLC Congress 2025 (PRNewswire) - "The safety and efficacy results of iza-bren as a monotherapy and in combination with Osimertinib in patients with advanced stages of EGFR mutated Non-Small Cell Lung Cancer will be presented at WCLC."

P1/2 data • P2 data • Non Small Cell Lung Cancer

Phase 1 Global Study of Iza-Bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (ESMO 2025) - No abstract available

Clinical • Metastases • P1 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Phase II Study of iza-bren (BL-B01D1) in Combination with Serplulimab in Patients with Small Cell Lung Cancer (SCLC) (ESMO 2025) - No abstract available

Clinical • Combination therapy • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Izalontamab Brengitecan (EGFRxHER3 ADC) Granted Breakthrough Therapy Designation by U.S. FDA for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer (PRNewswire) - "The FDA's decision was based on efficacy and safety data from three ongoing clinical trials: BL-B01D1-101 and BL-B01D1-203, conducted in China by Sichuan Biokin Pharmaceutical Co., Ltd., and the global BL-B01D1-LUNG-101 study conducted by SystImmune across the United States, Europe and Japan."

Breakthrough therapy • Non Small Cell Lung Cancer

Phase Ib/II Study of iza-bren (BL-B01D1), an EGFR x HER3 Bispecific Antibody-drug Conjugate (ADC), in Patients with Recurrent Metastatic Ovarian Cancer (OC) (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • Oncology • Ovarian Cancer • Solid Tumor

A phase 1/2a, open-label, dose-finding study of the safety, pharmacokinetics, and preliminary efficacy of iza-bren (BL-B01D1) combinations in patients with advanced solid tumors (ESMO 2025) - No abstract available

Clinical • Metastases • P1/2 data • PK/PD data • Oncology • Solid Tumor

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Recurrent or Metastatic Gynecological Malignancies (clinicaltrials.gov) - P1/2 | N=38 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Jun 2025 ➔ Dec 2025 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • Endometrial Cancer • Gynecologic Cancers • Oncology • Solid Tumor

Phase 2/3 Trial of Izalontamab Brengitecan vs Platinum-based Chemotherapy for Metastatic Urothelial Cancer With Disease Progression on or After Immunotherapy (clinicaltrials.gov) - P2/3 | N=470 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2/3 trial • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer (clinicaltrials.gov) - P3 | N=384 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Initiation date: May 2025 ➔ Aug 2025

Platinum resistant • Trial initiation date • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

BL-B01D1-101: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov) - P1 | N=570 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | N=96 ➔ 570 | Trial primary completion date: Jun 2025 ➔ Dec 2025

Enrollment change • Trial primary completion date • Solid Tumor

Izalontamab brengitecan: Data readout from P1 LUNG-101 trial (NCT05983432) for 1L NSCLC and advanced solid tumors in H1 2026 (Bristol-Myers Squibb) - Q2 2025 Results: Data readout from P1/2 trial (NCT06618287) for advanced solid tumors in 2027

P1 data • P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) (clinicaltrials.gov) - P2/3 | N=596 | Not yet recruiting | Sponsor: Bristol-Myers Squibb

New P2/3 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

BL-B01D1-104: A Study of BL-B01D1 in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial primary completion date: Jun 2025 ➔ Dec 2025

Trial primary completion date • Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor

A Study of BL-B01D1 and Almonertinib in Patients With Resectable EGFR+ Stage II-IIIB NSCLC (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Sichuan University | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01) (clinicaltrials.gov) - P2/3 | N=560 | Recruiting | Sponsor: Bristol-Myers Squibb | Not yet recruiting ➔ Recruiting

Enrollment open • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer

A bispecific antibody-drug conjugate targeting EGFR and HER3 in metastatic esophageal squamous cell carcinoma: a phase 1b trial. (PubMed, Nat Med) - P1 | "BL-B01D1 is a first-in-class antibody-drug conjugate consisting of an EGFR-HER3 bispecific antibody bound to a topoisomerase I inhibitor (Ed-04) payload via a cleavable linker...A further phase 3 clinical trial has already been initiated. ClinicalTrials.gov registration: NCT05262491 ."

Journal • P1 data • Esophageal Cancer • Esophageal Squamous Cell Carcinoma • Hematological Disorders • Interstitial Lung Disease • Leukopenia • Neutropenia • Oncology • Pulmonary Disease • Respiratory Diseases • Squamous Cell Carcinoma • Thrombocytopenia • EGFR • ERBB3

A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (clinicaltrials.gov) - P2 | N=206 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Cervical Cancer • Endometrial Cancer • Oncology • Solid Tumor

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 Cancer (clinicaltrials.gov) - P2 | N=198 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting | N=114 ➔ 198

Enrollment change • Enrollment closed • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR

A Study of BL-B01D1+PD-1/PD-L1 Monoclonal Antibody in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov) - P2 | N=46 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Interim analysis of Phase III trial of iza-bren (EGFR x HER3 dual-antibody ADC) for the treatment of locally advanced or metastatic nasopharyngeal carcinoma met primary endpoint [Google translation] (bydrug.pharmcube.com) - P3 | N=386 | BL-B01D1-303 (NCT06118333) | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | "Iza-bren (BL-B01D1), the first-in-class, new-concept EGFR x HER3 bispecific ADC independently developed by Baili Tianheng and the only one to enter Phase III clinical stage, reached the primary endpoint in the interim analysis of the Phase III clinical trial for nasopharyngeal carcinoma (study protocol number: BL-B01D1-303). The indication is: recurrent or metastatic nasopharyngeal carcinoma that has failed previous treatment with PD-1/PD-L1 monoclonal antibodies and at least two lines of chemotherapy (at least one line containing platinum)."

P3 data • Nasopharyngeal Carcinoma

A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced, Recurrent, or Metastatic HR+HER2- Breast Cancer (clinicaltrials.gov) - P3 | N=383 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor