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

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

A Study Comparing BL-B01D1 With Physician's Choice of Chemotherapy in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov) - P3 | N=386 | Active, not recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting ➔ Active, not recruiting

Enrollment closed • Head and Neck Cancer • Nasopharyngeal Carcinoma • Oncology • Solid Tumor • PD-L1

A Study to Evaluate the Safety, Tolerability, Drug Levels, and Preliminary Efficacy of BMS-986507 Combinations in Adult Participants With Advanced Solid Tumors (clinicaltrials.gov) - P1/2 | N=198 | Recruiting | Sponsor: Bristol-Myers Squibb | Trial completion date: Dec 2027 ➔ Aug 2028

Trial completion date • Lung Cancer • Oncology • Solid Tumor

Phase II Study of BL-B01D1 and Almonertinib for EGFR+ Stage II-IIIB NSCLC (clinicaltrials.gov) - P2 | N=40 | Not yet recruiting | Sponsor: Sichuan University

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

A Phase II Study to Evaluate the Safety and Efficacy of Neoadjuvant Therapy with BL-B01D1 in Combination with Almonertinib Followed by Adjuvant Almonertinib in Patients with Epidermal Growth Factor Receptor Mutation Positive Stage II-IIIB Resectable Non-Small Cell Lung Cancer (ChiCTR) - P2 | N=40 | Not yet recruiting | Sponsor: West China Hospital of Sichuan University; West China Hospital of Sichuan University

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

Phase II clinical study evaluating the efficacy and safety of injectable BL-B01D1 in patients with locally advanced or metastatic chordoma (ChiCTR) - P2 | N=50 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center; Chengdu Bailidote Biological Pharmaceutical Co., Ltd.

New P2 trial • Chordoma • Solid Tumor

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with driver genomic alterations (GA) outside of classic EGFR mutations. (ASCO 2025) - P1 | "In NSCLC pts with these GAs, iza-bren showed promising activity with a manageable safety profile, supporting further evaluation of iza-bren in these populations. Note: [1] Including pts w/o post-baseline scan."

Clinical • Metastases • P1 data • Alopecia • Anemia • Dental Disorders • Immunology • Leukopenia • Lung Cancer • Neutropenia • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Stomatitis • Thrombocytopenia • ALK • BRAF • HER-2 • KRAS • NTRK • ROS1 • SMARCA4

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic small cell lung cancer (SCLC). (ASCO 2025) - P1, P3 | "In SCLC pts, iza-bren has demonstrated an encouraging efficacy with a manageable safety profile. Notably, the high confirmed response rate of 75% in pts with limited prior treatment underscores its potential as a novel therapeutic option for SCLC, a disease with limited therapeutic advancements over decades. The phase III study of iza-bren in SCLC pts who received 1 prior line of PD(L)-1 and PBC combination treatment is ongoing (NCT06500026)."

Clinical • Metastases • P1 data • Anemia • Dental Disorders • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Leukopenia • Lung Cancer • Neutropenia • Oncology • Respiratory Diseases • Small Cell Lung Cancer • Solid Tumor • Stomatitis • Thrombocytopenia

Bristol Myers Squibb to Present Data at ASCO 2025 Highlighting Differentiated Research Platform of Oncology Treatments and Innovative Research Pipeline (Businesswire) - "Bristol Myers Squibb...announced the presentation of data across its oncology portfolio and pipeline at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting to be held May 30-June 3 in Chicago, Illinois. Data from more than 80 company-sponsored studies, investigator-sponsored studies, and collaborations showcase results spanning more than 20 cancer types."

Clinical data • Gastroesophageal Cancer • Gastroesophageal Junction Adenocarcinoma • Myelodysplastic Syndrome • Non Small Cell Lung Cancer • Non-Hodgkin’s Lymphoma • Small Cell Lung Cancer • Solid Tumor • Squamous Cell Carcinoma of Head and Neck

Preclinical studies of BR-2302: A HER3xEGFR bi-specific Exd-containing ADC (AACR 2025) - "To combat this issue, novel HER3-targeting therapies are under investigation, including antibody-drug conjugates (ADCs) such as Patritumab Deruxtecan (U3-1402), which have shown encouraging results in clinical trials, underscoring the potential of HER3 targeting to overcome resistance...Izalonatamab brengitecan (BL-B01D1), an ADC designed for simultaneous targeting of EGFR and HER3, has demonstrated substantial clinical benefits in heavily pretreated patients with EGFR-mutant non-small cell lung cancer (NSCLC)...Collectively, our findings indicate that BR-2302 possesses promising anti-tumor properties. This innovative therapeutic approach has the potential to improve treatment outcomes for patients with solid tumors expressing both HER3 and EGFR, warranting further clinical exploration."

Preclinical • Colon Cancer • Colorectal Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • ERBB3

CS5007: A novel EGFR and HER3 dual-targeted antibody-drug conjugate (ADC) with potent antitumor activity in preclinical studies (AACR 2025) - "For instance, MRG003, an EGFR-targeted ADC, has shown encouraging clinical outcomes in NPC and HNSCC...Daiichi's HER3-ADC, U3-1402, has shown promising clinical results in advanced EGFR-mutant NSCLC, confirming HER3 as a valid therapeutic target for ADC. Additionally, BL-B01D1, an EGFR/HER3 bispecific ADC, has shown encouraging phase 1 data in advanced cancers... CS5007 is a promising dual-targeted ADC that demonstrates potent antitumor efficacy with a favorable safety and PK profile. These preclinical findings support its further IND-enabling studies and clinical investigations for the treatment of various advanced solid tumors."

Preclinical • Colorectal Cancer • Head and Neck Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Carcinoma of Head and Neck • ERBB3

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

New P2 trial • Biliary Cancer • Biliary Tract Cancer • Oncology • Solid Tumor

Phase I study of iza-bren (BL-B01D1), an EGFR x HER3 bispecific antibody-drug conjugate (ADC), in patients with locally advanced or metastatic breast cancer (BC) (ESMO-BC 2025) - P1 | "In heavily pre-treated locally advanced or metastatic HER2- BC, iza-bren has demonstrated encouraging efficacy with a manageable safety profile, including in pts with HER2 zero expression."

Clinical • Metastases • P1 data • Breast Cancer • Oncology • Solid Tumor • HER-2

SystImmune, Inc. to Present Updated izalontamab brengitecan (iza-bren) Data in Locally Advanced or Metastatic Breast Cancer at ESMO Breast 2025 (PRNewswire) - "SystImmune, Inc...announced that one abstract on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the European Society for Medical Oncology (ESMO) Breast Cancer 2025 Annual Congress taking place May 14 – May 17 in Munich, Germany....Data will be presented at the meeting from an ongoing Ph1 clinical trial of iza-bren in patients with locally advanced or metastatic HER2- Breast Cancer."

P1 data • HER2 Negative Breast 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=540 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P3 trial • Platinum resistant • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

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

New P2 trial • Hepatocellular Cancer • Oncology • Solid Tumor

A Study of BL-B01D1 in Patients With Multiple Solid Tumors, Including Locally Advanced or Metastatic Urinary System Tumors (clinicaltrials.gov) - P2 | N=76 | Recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Apr 2025 ➔ Dec 2025 | Trial primary completion date: Apr 2025 ➔ Dec 2025

Trial completion date • Trial primary completion date • 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 | Not yet recruiting | Sponsor: Sichuan Baili Pharmaceutical Co., Ltd.

New P2 trial • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor

SystImmune, Inc. to Present New izalontamab brengitecan (iza-bren) Data in Small Cell Lung Cancer and Non-Small Cell Lung Cancer with Driver Genomic Alterations (GA) outside of Classic EGFR Mutations at ASCO Congress 2025 (PRNewswire) - "SystImmune, Inc...announced that two abstracts on izalontamab brengitecan (iza-bren), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC) will be presented at the American Society of Clinical Oncology (ASCO) 2025 Annual Meeting taking place May 30 – June 3 in Chicago....Expanded results from clinical trials of iza-bren will include data from patients with advanced stages of Small Cell Lung Cancer and Non-Small Cell Lung Cancer with driver genomic alterations (GA) outside of classic EGFR mutations and having multiple lines of prior therapies."

P1 data • Non Small Cell Lung Cancer • Small Cell Lung Cancer

DB-1418, a bispecific antibody-drug conjugate (ADC) targeting EGFR and HER3, demonstrates superior and broad antitumor efficacy and favorable safety in preclinical models (AACR 2025) - "Notably, in an osimertinib-resistant NSCLC xenograft model with the C797S mutation, DB-1418 induced tumor regression with a TGI of 98% at a dose of 6 mg/kg Q3W, significantly higher than the BL-B01D1 analog at 6 mg/kg Q3W (TGI of 68%, p<0.01). DB-1418 has shown promising pharmacological and pharmacokinetic properties, differentiated from the current clinical trial bispecific ADC targeting EGFR and HER3, with a broader therapeutic window. DB-1418 offers additional treatment options for patients who have developed resistance to EGFR tyrosine kinase inhibitors (TKIs) and addresses other unmet medical needs."

Preclinical • Bladder Cancer • Genito-urinary Cancer • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Prostate Cancer • Solid Tumor • EGFR • ERBB3