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    DRUG CLASS:

    DLL3-targeted antibody-drug conjugate

    Related drugs:
    10d
    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
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    DLL3 (Delta Like Canonical Notch Ligand 3)
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    Imdelltra (tarlatamab-dlle)
    27d
    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
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    DLL3 (Delta Like Canonical Notch Ligand 3)
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    DLL3 expression
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    cisplatin • carboplatin • CS1002 (ipilimumab biosimilar) • AiRuiLi (adebrelimab)
    2ms
    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
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    DLL3 (Delta Like Canonical Notch Ligand 3)
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    Tecentriq (atezolizumab) • carboplatin
    2ms
    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
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    DLL3 (Delta Like Canonical Notch Ligand 3)
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    IDH wild-type
    3ms
    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
    3ms
    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
    4ms
    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
    5ms
    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
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    Imfinzi (durvalumab) • IDE161
    6ms
    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
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    PD-L1 (Programmed death ligand 1) • KIT (KIT proto-oncogene, receptor tyrosine kinase) • DLL3 (Delta Like Canonical Notch Ligand 3)
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    PD-L1 expression • KIT expression
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    Rova-T (rovalpituzumab tesirine)
    7ms
    A Study of ZL-1310 Versus Investigator's Choice of Therapy in Participants With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=665, Not yet recruiting, Zai Lab (Shanghai) Co., Ltd.
    New P3 trial
    7ms
    Evaluating BL-M14D1 in Subjects With Locally Advanced or Metastatic Small Cell Lung Cancer and Neuroendocrine Tumors (clinicaltrials.gov)
    P1, N=120, Recruiting, SystImmune Inc. | Not yet recruiting --> Recruiting | Initiation date: Sep 2025 --> Apr 2025
    Enrollment open • Trial initiation date
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    DLL3 (Delta Like Canonical Notch Ligand 3)
    8ms
    Antibody Drugs Conjugates in Small-Cell Lung Cancer: Present-Day Status and Promises. (PubMed, Oncologist)
    While ADCs have generated encouraging response rates in SCLC, durability has remained limited. Future development will require optimization of payloads, linkers, and trial design to determine whether ADCs can achieve a sustained role in this disease.
    Journal
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    CD276 (CD276 Molecule) • DLL3 (Delta Like Canonical Notch Ligand 3) • SEZ6 (Seizure Related 6 Homolog)