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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:
    3d
    A Clinical Trial of Ifinatamab Deruxtecan in People With Advanced Esophageal Cancer (MK-3475-06F) (clinicaltrials.gov)
    P1/2, N=60, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • ifinatamab deruxtecan (DS-7300)
    7d
    Ifinatamab deruxtecan, a B7-H3-directed antibody-drug conjugate, in patients with advanced solid tumours (IDeate-PanTumor01): dose-escalation results from a phase 1/2 trial. (PubMed, Lancet Oncol)
    The maximum tolerated dose was not reached with ifinatamab deruxtecan; however, one death due to treatment-related interstitial lung disease highlights the importance of prompt evaluation and careful management of patients who develop interstitial lung disease. Promising antitumour activity was observed across various solid tumours. These findings support further evaluation of ifinatamab deruxtecan in randomised controlled trials.
    P1/2 data • Journal • Pan tumor • First-in-human
    |
    CD276 (CD276 Molecule)
    |
    ifinatamab deruxtecan (DS-7300)
    7d
    IDeate-Prostate01: A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001) (clinicaltrials.gov)
    P3, N=1440, Recruiting, Merck Sharp & Dohme LLC
    Trial initiation date
    |
    docetaxel • prednisone • ifinatamab deruxtecan (DS-7300)
    15d
    A Clinical Study of Ifinatamab Deruxtecan Based Treatment Combinations or as Monotherapy to Treat Metastatic Castrate Resistant Prostate Cancer (mCRPC) (MK-2400-01A/IDeate-Prostate02) (clinicaltrials.gov)
    P1/2, N=360, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Feb 2030 --> Apr 2031 | Trial primary completion date: Feb 2030 --> Apr 2031
    Trial completion date • Trial primary completion date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • ifinatamab deruxtecan (DS-7300) • opevesostat (MK-5684)
    24d
    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=262, Recruiting, Merck Sharp & Dohme LLC | N=59 --> 262
    Enrollment change
    |
    Imfinzi (durvalumab) • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    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=59, Recruiting, Merck Sharp & Dohme LLC | N=40 --> 59
    Enrollment change
    |
    CD276 (CD276 Molecule)
    |
    Imfinzi (durvalumab) • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    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