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    DRUG CLASS:

    DLL3-targeted antibody-drug conjugate

    Related drugs:
    1d
    A Study of BL-M14D1 in Combination With Atezolizumab in Patients With Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=36, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P2 trial
    |
    Tecentriq (atezolizumab)
    8d
    ZL-1310-003: A Study to Test How Well ZL-1310 may Work Compared to Therapies Selected by the Investigator in Treating Patients with Relapsed Small Cell Lung Cancer (2025-522818-23-00)
    P2/3, N=131, Not yet recruiting, Zai Lab (US) LLC
    New P2/3 trial
    |
    topotecan
    15d
    Evaluate BL-M14D1 Plus Atezolizumab vs Standard of Care in First-Line Extensive-Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=550, Not yet recruiting, SystImmune Inc.
    New P3 trial
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • Zepzelca (lurbinectedin)
    1m
    Addressing Unmet Needs in the Management of Small Cell Lung Cancer: Treatment of Brain Metastases, Quality of Life, and the Role of Real-World Evidence. (PubMed, Curr Treat Options Oncol)
    Emerging therapies, such as antibody-drug conjugates targeting B7-H3/DLL3 (I-Dxd, ZL-1310) and bispecific antibody tarlatamab, have demonstrated intracranial response rates of 62.5%-71%. Future directions involve developing new drugs with high blood-brain barrier penetration, such as radioligand therapy, conducting prospective studies to optimize HA and SRS applications, establishing high-quality RWE databases to support personalized treatments, exploring molecular subtypes (SCLC-A/N/P/I) and leveraging AI technologies to advance precision radiotherapy. SCLC management needs to be patient-centered, integrating precise treatment of brain metastases, QoL improvement, and the application of RWE to achieve a balance between survival benefits and QoL.
    Review • Journal • HEOR • Real-world evidence
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Imdelltra (tarlatamab-dlle)
    2ms
    Multicenter, open-access Phase II clinical study of SHR-4849 injection combined with other anti-tumor drugs in patients with malignant solid tumors (ChiCTR2600117863)
    P2, N=120, Shandong Cancer Hospital; Suzhou Shengdiya Biomedical Co., LTD
    New P2 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    cisplatin • carboplatin • CS1002 (ipilimumab biosimilar) • AiRuiLi (adebrelimab)
    3ms
    ZL-1310-001: A Study of ZL-1310 in Subjects With Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=339, Recruiting, Zai Lab (Shanghai) Co., Ltd. | N=112 --> 339
    Enrollment change
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Tecentriq (atezolizumab) • carboplatin
    3ms
    A Phase I Study of FZ-AD005 in Patients With High-Grade Glioma (HGG) (clinicaltrials.gov)
    P1, N=40, Not yet recruiting, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd.
    New P1 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    IDH wild-type
    4ms
    A Study of FZ-AD005 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=162, Recruiting, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Trial completion date: Jun 2026 --> Dec 2027 | Trial primary completion date: Dec 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • First-in-human
    4ms
    A Study of ZL-1310 in Participants With Selected Solid Tumors (clinicaltrials.gov)
    P1/2, N=112, Recruiting, Zai Lab (Shanghai) Co., Ltd. | N=86 --> 112 | Trial completion date: Jun 2027 --> Dec 2027 | Trial primary completion date: Dec 2026 --> Aug 2027
    Enrollment change • Trial completion date • Trial primary completion date
    5ms
    ZL-1310-003: A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=480, Recruiting, Zai Lab (Shanghai) Co., Ltd. | Not yet recruiting --> Recruiting | Trial completion date: May 2029 --> Nov 2028 | Trial primary completion date: Nov 2028 --> Jun 2028
    Enrollment open • Trial completion date • Trial primary completion date
    6ms
    A Study of IDE849 in Patients With DLL3 Expressing Tumors Including Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=208, Recruiting, IDEAYA Biosciences | N=90 --> 208
    Enrollment change
    |
    Imfinzi (durvalumab) • IDE161
    7ms
    A novel nomogram based on DLL3 and PD-L1 for predicting the prognosis of patients with small cell lung cancer. (PubMed, BMC Cancer)
    The prognostic model developed in this study offers predictive value in estimating 12-month survival probability for SCLC patients, aiding clinicians in making more informed treatment decisions.
    Journal • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    PD-L1 expression • KIT expression
    |
    Rova-T (rovalpituzumab tesirine)