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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    2d
    Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)
    5d
    A Multicenter, Open-label, Phase II Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of YL202 in Subjects With Locally Advanced or Metastatic Breast Cancer Who Are TNBC and HR Positive, HER2 Zero, or HER2 Hypoactive (ChiCTR2400089158)
    P2, N=180, Recruiting, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center
    New P2 trial • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    HR positive • HER-2 negative • HER-2 expression • HER-2 underexpression • PGR expression • HER-2 negative + HR negative
    |
    BNT326
    5d
    A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetic Profiles, and Preliminary Efficacy of SYS6023 in Patients with Advanced Solid Tumors (ChiCTR2400089836)
    P1, N=388, Recruiting, Shanghai Chest Hospital; CSPC Megalith Biopharmaceutical Co., Ltd
    New P1 trial • Metastases
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ER (Estrogen receptor) • ALK (Anaplastic lymphoma kinase) • PGR (Progesterone receptor) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NRG1 (Neuregulin 1) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • BRAF mutation • HER-2 amplification • HER-2 negative • BRAF V600 • HER-2 expression • ALK positive • MET amplification • ALK fusion • ERBB3 expression • RET mutation • ROS1 fusion • MET mutation • NRG1 fusion • RET rearrangement • KRAS G12 • KRAS amplification • ER expression • PGR expression • ALK-ROS1 fusion • NRG1 fusion • NTRK fusion
    7d
    ICARUS-BREAST01: Patritumab Deruxtecan (U3-1402) in Unresectable Locally Advanced or Metastatic Breast Cancer (clinicaltrials.gov)
    P2, N=99, Active, not recruiting, Gustave Roussy, Cancer Campus, Grand Paris | Recruiting --> Active, not recruiting | N=170 --> 99 | Trial completion date: Jun 2026 --> Apr 2028 | Trial primary completion date: Jan 2024 --> Apr 2025
    Enrollment closed • Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HR positive • HER-2 negative
    |
    patritumab deruxtecan (U3-1402)
    11d
    A Study of SHR-A2009 Versus Platinum-based Chemotherapy in EGFR-mutated, Advanced or Metastatic NSCLC (clinicaltrials.gov)
    P3, N=500, Not yet recruiting, Suzhou Suncadia Biopharmaceuticals Co., Ltd.
    New P3 trial • Metastases
    |
    cisplatin • carboplatin • SHR-A2009
    11d
    HERTHENA-Lung02: A Study of Patritumab Deruxtecan Versus Platinum-based Chemotherapy in Metastatic or Locally Advanced EGFRm NSCLC After Failure of EGFR TKI Therapy (clinicaltrials.gov)
    P3, N=586, Active, not recruiting, Daiichi Sankyo | Trial primary completion date: Aug 2024 --> May 2024
    Trial primary completion date • Metastases
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • carboplatin • patritumab deruxtecan (U3-1402)
    18d
    A Study of BL-B01D1 in Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    izalontamab brengitecan (BL-B01D1)
    22d
    A Study of BL-B01D1, SI-B003 and BL-B01D1+SI-B003 in Patients With Recurrent or Metastatic Cervical Cancer and Other Gynecological Malignancies (clinicaltrials.gov)
    P2, N=130, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=98 --> 130
    Enrollment change • Combination therapy • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    24d
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (clinicaltrials.gov)
    P1/2, N=130, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    patritumab deruxtecan (U3-1402)
    30d
    A Clinical Trial of SIBP-A13 Injection in the Treatment of Advanced Malignant Solid Tumor Patients. (clinicaltrials.gov)
    P1, N=144, Recruiting, Shanghai Institute Of Biological Products | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1m
    BL-B01D1-204-05: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer, Nasopharyngeal Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=332, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=126 --> 332
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Urological Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=26, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Jun 2025 | Trial primary completion date: Aug 2024 --> Jun 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    1m
    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=218, Not yet recruiting, Bristol-Myers Squibb
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    2ms
    A Study of SI-B003, BL-B01D1+SI-B003 and BL-B01D1+PD-1 Monoclonal Antibody in Patients With Locally Advanced or Metastatic Esophageal Cancer, Gastric Cancer, Colorectal Cancer and Other Gastrointestinal Tumors (clinicaltrials.gov)
    P2, N=376, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=268 --> 376
    Enrollment change • Combination therapy • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 negative
    |
    izalontamab brengitecan (BL-B01D1) • danvilostomig (SI-B003)
    2ms
    BL-B01D1-204-01: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=66, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=36 --> 66
    Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Active, not recruiting --> Recruiting | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Dec 2024 --> Dec 2025
    Enrollment open • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2)
    |
    EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    BNT326
    2ms
    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, Sichuan Baili Pharmaceutical Co., Ltd. | N=32 --> 76
    Enrollment change • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    DB-1310-O-1001: A Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=1000, Recruiting, DualityBio Inc. | N=287 --> 1000
    Enrollment change
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Herceptin (trastuzumab) • Tagrisso (osimertinib) • DB-1310
    2ms
    A Study of BL-B01D1 in Patients With Recurrent Glioblastoma (clinicaltrials.gov)
    P2, N=20, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    TUXEDO-3: HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (clinicaltrials.gov)
    P2, N=63, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting
    Enrollment closed • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M • ERBB3 expression • TROP2 expression • ER expression • PGR expression
    |
    patritumab deruxtecan (U3-1402)
    2ms
    To Evaluate the Phase I Clinical Study of JSKN016 in Chinese Patients With Advanced Malignant Solid Tumors (clinicaltrials.gov)
    P1, N=140, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1 trial • Metastases
    2ms
    A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumor and Other Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (clinicaltrials.gov)
    P1/2, N=130, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    patritumab deruxtecan (U3-1402)
    2ms
    BL-B01D1-101: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Solid Tumor (clinicaltrials.gov)
    P1, N=96, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    2ms
    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, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Aug 2024 --> Dec 2024 | Trial primary completion date: Aug 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    U31402-A-U103: HER3-DXd (Patritumab Deruxtecan; U3-1402) in Combination With Osimertinib in Subjects With Locally Advanced or Metastatic EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=280, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed • Combination therapy • Metastases
    |
    Tagrisso (osimertinib) • patritumab deruxtecan (U3-1402)
    3ms
    A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Unresectable Locally Advanced or Recurrent Metastatic Triple-negative Breast Cancer (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-304: A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=652, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • izalontamab brengitecan (BL-B01D1)
    3ms
    BL-B01D1-204-02: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma and Other Solid Tumors (clinicaltrials.gov)
    P2, N=52, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    3ms
    HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=277, Active, not recruiting, Daiichi Sankyo | Trial completion date: Nov 2024 --> Jan 2026
    Trial completion date • Metastases
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    patritumab deruxtecan (U3-1402)
    3ms
    A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    3ms
    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=114, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=42 --> 114
    Enrollment change • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor)
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)
    3ms
    ERBB3 Targeting: A Promising Approach to Overcoming Cancer Therapeutic Resistance. (PubMed, Cancer Lett)
    Several ERBB3-directed monoclonal antibodies, bispecific antibodies, and the emerging antibody-drug conjugate demonstrate encouraging clinical outcomes for improving therapeutic efficacy and overcoming resistance, especially when combined with other anti-cancer approaches. More research efforts are needed to identify appropriate biomarkers tailored for ERBB3-targeted therapies.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    4ms
    The Evolving Paradigm of Antibody-Drug Conjugates Targeting the ErbB/HER Family of Receptor Tyrosine Kinases. (PubMed, Pharmaceutics)
    The clinical utility of HER-targeted ADCs is exemplified by the immense success of HER2-targeted ADCs including trastuzumab emtansine and trastuzumab deruxtecan. In this review, we extensively detail clinical-stage EGFR-, HER2-, and HER3-targeting monospecific ADCs as well as novel clinical and pre-clinical bispecific ADCs (bsADCs) directed against this receptor family. We close by discussing nascent trends in the development of HER-targeting ADCs, including novel ADC payloads and HER ligand-targeted ADCs.
    Review • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ERBB4 (erb-b2 receptor tyrosine kinase 4)
    |
    Kadcyla (ado-trastuzumab emtansine) • Enhertu (fam-trastuzumab deruxtecan-nxki)
    4ms
    AMT-562 in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=72, Recruiting, Multitude Therapeutics (Australia) Pty Ltd | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    AMT-562
    4ms
    BL-B01D1-204-01: A Study of BL-B01D1+PD-1 Monoclonal Antibody in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=36, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting | N=60 --> 36
    Enrollment open • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    4ms
    HER3 Expression Across Genomic Subsets of NSCLC (IASLC-WCLC 2024)
    High ERBB3 expression was associated with better survival. These data support the role of HER3 as a viable therapeutic target across multiple molecular subsets.
    HER-2 (Human epidermal growth factor receptor 2) • KRAS (KRAS proto-oncogene GTPase) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    KRAS mutation • EGFR mutation • KRAS G12C • EGFR L858R • HER-2 expression • EGFR exon 19 deletion • EGFR exon 20 insertion • EGFR expression • MET exon 14 mutation • ALK fusion • ERBB3 expression • ROS1 fusion • KRAS G12 • EGFR exon 20 mutation • ERBB3 mutation • KRAS expression
    |
    MI Tumor Seek™
    4ms
    Study to Evaluate BL-B01D1 in Patients With Metastatic or Unresectable Non-Small Cell Lung Cancer (NSCLC) and Other Solid Tumors (clinicaltrials.gov)
    P1, N=260, Recruiting, SystImmune Inc. | Trial completion date: Sep 2025 --> Mar 2028 | Trial primary completion date: Jul 2024 --> Dec 2025
    Trial completion date • Trial primary completion date • Metastases
    |
    izalontamab brengitecan (BL-B01D1)
    4ms
    HER3 receptor and its role in the therapeutic management of metastatic breast cancer. (PubMed, J Transl Med)
    This review provides an overview of recent advancements in HER3 research, historical initiatives, and innovative approaches in targeted HER3 therapy for metastatic breast cancer. Evaluating the advantages and disadvantages of current methods may yield valuable insights and lessons.
    Review • Journal • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    4ms
    Spotlight on Patritumab Deruxtecan (HER3-DXd) from HERTHENA Lung01. Is a Median PFS of 5.5 Months Enough in Light of FLAURA-2 and MARIPOSA? (PubMed, Lung Cancer (Auckl))
    This prioritization by the FDA is grounded in compelling results from the global Phase II HERTHENA-Lung01 trial, wherein HER3-DXd exhibited clinically meaningful efficacy, achieving a median progression-free survival (mPFS) of 5.5 months in patients with heavily treated EGFR-mutated NSCLC. A pivotal question remains: Is a mPFS of 5.5 months sufficient in the context of the evolving first-line landscape observed in the FLAURA-2 and MARIPOSA trials?
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Tagrisso (osimertinib) • patritumab deruxtecan (U3-1402)
    4ms
    A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=652, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    topotecan • izalontamab brengitecan (BL-B01D1)
    4ms
    A Study of BL-B01D1 in Combination With Osimertinib Mesylate Tablets in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial • Combination therapy • Metastases
    |
    Tagrisso (osimertinib) • izalontamab brengitecan (BL-B01D1)