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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:
    9d
    Global landscape analysis of antibody-drug conjugate clinical trials for prostatic neoplasms: current status, opportunities and challenges. (PubMed, Front Immunol)
    Several next-generation ADC programmes, including PSMA- and B7-H3-directed agents such as MEDI3726 and DS-7300, have reported early antitumour activity signals. At the same time, the global development landscape remains fragmented across targets, payload classes, endpoints, and sponsor types. This study therefore aimed to map the contemporary landscape of ADC clinical trials for prostatic neoplasms, clarify current development patterns, identify translational opportunities and gaps, and provide an integrated overview to support future clinical development.
    Journal
    |
    CD276 (CD276 Molecule)
    |
    ifinatamab deruxtecan (DS-7300) • MEDI3726
    14d
    A Study of Ifinatamab Deruxtecan in Pediatric Participants With Relapsed or Refractory Solid Tumors (MK-9999-01D/LIGHTBEAM-U01) (clinicaltrials.gov)
    P1/2, N=134, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    ifinatamab deruxtecan (DS-7300)
    23d
    A clinical trial of ifinatamab deruxtecan in people under age 18 who have certain types of cancer (MK-9999-01D) (2025-522339-32-00)
    P1/2, N=4, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    ifinatamab deruxtecan (DS-7300)
    1m
    Improve the Efficacy of B7-H3-Targeting Antibody-Drug Conjugate DS-7300a in TP53-deficient Tumors by Inducing Ferroptosis. (PubMed, bioRxiv)
    Using isogeneic xenograft models and a newly developed humanized B7-H3 PCa model, we demonstrated that inducing ferroptosis by pharmacological inhibition of GPX4 enhances DS-7300a's efficacy in TP53 -deficient tumors. Our studies demonstrate that TP53 status dictates anti-tumor responses to DS-7300a, and ferroptosis induction represents a promising therapeutic approach to overcome resistance to DS-7300a in malignancies harboring TP53 defects.
    Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • GPX4 (Glutathione Peroxidase 4)
    |
    TP53 mutation
    |
    ifinatamab deruxtecan (DS-7300)
    1m
    A clinical trial of ifinatamab deruxtecan in people with advanced esophageal cancer (MK-3475-06F) (2026-525213-31-00)
    P1/2, N=12, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    Keytruda (pembrolizumab) • ifinatamab deruxtecan (DS-7300)
    2ms
    Medical Access Program for Ifinatamab Deruxtecan in 3L+ Pretreated Extensive-stage Small Cell Lung Cancer (clinicaltrials.gov)
    P=N/A, N=0, Temporarily Not Available, Daiichi Sankyo
    New trial
    |
    ifinatamab deruxtecan (DS-7300)
    2ms
    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)
    3ms
    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)
    3ms
    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)
    3ms
    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 • enzalutamide • abiraterone acetate • ifinatamab deruxtecan (DS-7300) • opevesostat (MK-5684)
    3ms
    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)
    3ms
    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)