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    DRUG:

    ifinatamab deruxtecan (DS-7300)

    i
    Other names: DS-7300, DS7300, DS 7300, DS-7300a, anti-B7-H3/DXd ADC, MABX-9001a/DXd ADC, anti-B7H3 antibody+MAAA-1181a, B7-H3 DXd-ADC, I-Dxd, MK-2400, DS7300a, DS 7300a, IDxd, I Dxd, MK2400, MK 2400
    Company:
    Daiichi Sankyo, Merck (MSD)
    Drug class:
    Topoisomerase I inhibitor, B7-H3-targeted antibody-drug conjugate
    Related drugs:
    17d
    A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (clinicaltrials.gov)
    P1/2, N=170, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    22d
    A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • ifinatamab deruxtecan (DS-7300)
    26d
    IDeate-Lung02: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=540, Recruiting, Daiichi Sankyo | Active, not recruiting --> Recruiting
    Enrollment open
    |
    topotecan • Zepzelca (lurbinectedin) • ifinatamab deruxtecan (DS-7300) • Calsed (amrubicin)
    1m
    A Study to Evaluate the Safety and Efficacy of Gocatamig (MK-6070) and Ifinatamab Deruxtecan (I-DXd) in Participants With Relapsed/Refractory Extensive-Stage Small Cell Lung Cancer (MK-6070-002) (clinicaltrials.gov)
    P1/2, N=242, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Aug 2029 --> Feb 2030
    Trial completion date
    |
    Imfinzi (durvalumab) • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    1m
    A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov)
    P1/2, N=232, Active, not recruiting, Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Tecentriq (atezolizumab) • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    2ms
    KEYMAKER-U06 Substudy 06E: Substudy 06E: Umbrella Study of Combination Therapies in Esophageal Cancer (MK-3475-06E/KEYMAKER-U06) (clinicaltrials.gov)
    P1/2, N=298, Recruiting, Merck Sharp & Dohme LLC | N=228 --> 298
    Enrollment change
    |
    Keytruda (pembrolizumab) • 5-fluorouracil • oxaliplatin • ifinatamab deruxtecan (DS-7300) • Jiataile (sacituzumab tirumotecan) • levoleucovorin calcium
    4ms
    A Clinical Study of Gocatamig (MK-6070) and Infinatamab Deruxtecan (MK-2400) in People With Small Cell Lung Cancer (MK-6070-003) (clinicaltrials.gov)
    P1/2, N=170, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    4ms
    Bridging Knowledge Gaps in Small Cell Lung Cancer: Data, Challenges and Priorities. (PubMed, Curr Oncol)
    Novel agents such as tarlatamab (DLL3-targeting) and ifinatamab deruxtecan (B7-H3-targeting) have shown encouraging efficacy in early-phase trials, though predictive markers remain elusive. A multi-dimensional approach combining tissue, blood, and immune profiling is essential to advance precision oncology in SCLC and improve patient selection for emerging therapies.
    Review • Journal • Tumor mutational burden • PD(L)-1 Biomarker • IO biomarker
    |
    PD-L1 (Programmed death ligand 1) • DLL3 (Delta Like Canonical Notch Ligand 3) • YAP1 (Yes associated protein 1) • POU2F3 (POU Class 2 Homeobox 3) • ASCL1 (Achaete-Scute Family BHLH Transcription Factor 1) • NEUROD1 (Neuronal Differentiation 1)
    |
    ifinatamab deruxtecan (DS-7300) • Imdelltra (tarlatamab-dlle)
    4ms
    IDeate-Lung01: Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov)
    P2, N=187, Active, not recruiting, Daiichi Sankyo | Trial completion date: Nov 2025 --> Dec 2026
    Trial completion date
    |
    ifinatamab deruxtecan (DS-7300)
    4ms
    IDeate-Lung02: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=540, Active, not recruiting, Daiichi Sankyo | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    topotecan • Zepzelca (lurbinectedin) • ifinatamab deruxtecan (DS-7300) • Calsed (amrubicin)
    5ms
    Ifinatamab Deruxtecan in Patients With Extensive-Stage Small-Cell Lung Cancer: Primary Analysis of the Phase 2 IDeate-Lung01 Trial. (PubMed, J Clin Oncol)
    I-DXd 12 mg/kg Q3W showed promising efficacy in patients with previously treated ES-SCLC. The observed safety profile was consistent with previous reports, with no new safety signals identified.
    P2 data • Journal
    |
    CD276 (CD276 Molecule)
    |
    ifinatamab deruxtecan (DS-7300)
    5ms
    IDeate-Pantumor 01: Study of Ifinatamab Deruxtecan (DS-7300a, I-DXd) in Participants With Advanced Solid Malignant Tumors (clinicaltrials.gov)
    P1/2, N=250, Recruiting, Daiichi Sankyo | Trial completion date: Mar 2027 --> Oct 2029 | Trial primary completion date: Dec 2025 --> Apr 2027
    Trial completion date • Trial primary completion date • Pan tumor • First-in-human
    |
    ifinatamab deruxtecan (DS-7300)