^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    Topoisomerase I inhibitor

    Related drugs:
    1d
    A Study Comparing BL-M05D1 With the Investigator's Choice of Treatment Regimen in Patients With Claudin (CLDN)18.2-Positive Advanced Gastric Cancer or Gastroesophageal Junction Adenocarcinoma (GC/GEJC) Who Have Received Prior First-Line Treatment (clinicaltrials.gov)
    P3, N=438, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    paclitaxel • docetaxel • irinotecan
    1d
    ESPERANZA: External Control Arm Study for T-DXd for Patients With HER2 IHC3+ Solid Tumors (clinicaltrials.gov)
    P=N/A, N=140, Completed, AstraZeneca | Recruiting --> Completed | N=105 --> 140
    Trial completion • Enrollment change
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • TMB (Tumor Mutational Burden)
    |
    MSI-H/dMMR • BRAF mutation • HER-2 expression • BRAF wild-type • RAS wild-type • HER-2 positive + RAS wild-type
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki)
    1d
    SEACLIFF: Study of AZD0516 as Monotherapy and in Combination in Participants With Metastatic Prostate Cancer (clinicaltrials.gov)
    P1/2, N=177, Recruiting, AstraZeneca
    Trial initiation date • First-in-human
    |
    STEAP1 (STEAP Family Member 1)
    |
    AZD9574
    1d
    EPOC2003: Phase 2 Study of Trastuzumab Deruxtecan in the Neoadjuvant Treatment, or Trastuzumab Deruxtecan Plus Capecitabine Plus Durvalumab(MEDI4736) in the Preoperative and Postoperative Adjuvant Treatment for Patients With HER2 Positive Gastric and Gastroesophageal Junction Adenocarcinoma (clinicaltrials.gov)
    P2, N=64, Active, not recruiting, National Cancer Center Hospital East | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 overexpression
    |
    Imfinzi (durvalumab) • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine
    1d
    A Study of BL-M07D1 in Patients With a Variety of Solid Tumors Including Locally Advanced or Metastatic HER2-positive/Low-expressing Urinary and Gastrointestinal Tumors (clinicaltrials.gov)
    P1/2, N=42, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Trial completion date: Mar 2026 --> Dec 2026 | Trial primary completion date: Mar 2026 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HER-2 expression
    |
    trastuzumab brengitecan (BL-M07D1)
    1d
    A Study of BL-M07D1 Combined With Pertuzumab Versus Docetaxel Plus Trastuzumab and Pertuzumab in Patients With First-line HER2-positive Recurrent or Metastatic Breast Cancer (clinicaltrials.gov)
    P3, N=596, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • docetaxel • Perjeta (pertuzumab) • trastuzumab brengitecan (BL-M07D1)
    1d
    A Study to Assess Adverse Events, and How Intravenously (IV) Infused ABBV-969 Moves Through the Bodies of Adult Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P1, N=230, Recruiting, AbbVie | N=36 --> 230
    Enrollment change • Adverse events • First-in-human
    2d
    EGFR- and HER3-targeted bispecific antibody-drug conjugate demonstrates anti-tumor activity in metastatic castration-resistant prostate cancer. (PubMed, J Clin Invest)
    Izalontamab brengitecan (Iza-bren; BL-B01D1) is a bispecific ADC targeting EGFR and HER3 that has demonstrated activity in other malignancies. Importantly, tumor tissue obtained at progression after BL-B01D1 treatment confirmed ABCG2 upregulation, validating a clinically relevant resistance mechanism. These findings support BL-B01D1 as a promising therapeutic strategy in mCRPC and nominate ABCG2 as a rational target for overcoming resistance.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
    |
    EGFR expression
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2d
    SGNCEA5C-001: A Study of SGN-CEACAM5C in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=914, Recruiting, Seagen, a wholly owned subsidiary of Pfizer | Suspended --> Recruiting | N=175 --> 914
    Enrollment open • Enrollment change
    |
    Avastin (bevacizumab) • 5-fluorouracil • oxaliplatin • leucovorin calcium
    2d
    A Phase 1/2 Study of KHN922 for Injection (clinicaltrials.gov)
    P1/2, N=276, Not yet recruiting, Chengdu Kanghong Biotech Co., Ltd.
    New P1/2 trial
    2d
    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: Jan 2026 --> Jul 2026
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    2d
    Clinical Effectiveness and Safety of SHR-A1811 in Chinese Patients With HER2-Altered NSCLC (clinicaltrials.gov)
    P=N/A, N=1000, Not yet recruiting, Nanjing Tianyinshan Hospital
    New trial
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    trastuzumab rezetecan (SHR-A1811)