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    DRUG CLASS:

    B7-H3-targeted antibody-drug conjugate

    Related drugs:
    2d
    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 primary completion date: Dec 2024 --> Dec 2025
    Trial primary completion date
    |
    ifinatamab deruxtecan (DS-7300)
    3d
    A Study of the ILB-3101 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=240, Recruiting, Innolake Biopharm | Not yet recruiting --> Recruiting | Initiation date: Aug 2024 --> Oct 2024
    Enrollment open • Trial initiation date • Metastases
    5d
    A Phase 1 Study Investigating the Safety, Tolerability, Pharmacokinetics, and Preliminary Antitumor Activity of BGB-C354, an Antibody-Drug Conjugate Targeting B7H3, Alone and in Combination With Anti-PD-1 Monoclonal Antibody Tislelizumab in Patients With Advanced Solid Tumors (ChiCTR2400091198)
    P1, N=92, Not yet recruiting, Jilin Cancer Hospital; Jilin Cancer Hospital
    New P1 trial • Combination therapy • Metastases
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • CD276 (CD276 Molecule) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    EGFR mutation • HER-2 negative • EGFR wild-type • CD276 expression
    |
    Tevimbra (tislelizumab-jsgr)
    30d
    Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
    P2, N=192, Active, not recruiting, MacroGenics | Trial primary completion date: Feb 2025 --> Jul 2024
    Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
    30d
    A Study of Ifinatamab Deruxtecan in Subjects With Advanced or Metastatic ESCC (IDeate-Esophageal01) (clinicaltrials.gov)
    P3, N=510, Not yet recruiting, Daiichi Sankyo
    New P3 trial • Metastases
    |
    paclitaxel • docetaxel • irinotecan • ifinatamab deruxtecan (DS-7300)
    1m
    ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=460, Recruiting, Hansoh BioMedical R&D Company | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • GSK5764227
    1m
    A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=400, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial • Metastases
    |
    gemcitabine • docetaxel • capecitabine • YL201
    1m
    BCL-XL-targeting antibody-drug conjugates are active in preclinical models and mitigate on-mechanism toxicity of small-molecule inhibitors. (PubMed, Sci Adv)
    While an unprecedented BCL-XL-mediated toxicity was uncovered in monkey kidneys upon repeat dosing of AM1-15, this toxicity was mitigated via further drug-linker modification to afford AM1-AAA (AM1-25). The AAA drug-linker has since been incorporated into mirzotamab clezutoclax, the first selective BCL-XL-targeting agent to enter human clinical trials.
    Preclinical • Journal
    |
    EGFR (Epidermal growth factor receptor) • BCL2L1 (BCL2-like 1)
    |
    mirzotamab clezutoclax (ABBV-155)
    2ms
    A Phase III Study to Evaluate the Efficacy and Safety of YL201 in Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=438, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P3 trial
    |
    topotecan • YL201
    2ms
    First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=360, Recruiting, DualityBio Inc. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    2ms
    Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
    P2, N=192, Active, not recruiting, MacroGenics | N=382 --> 192 | Trial completion date: May 2027 --> Feb 2025 | Trial primary completion date: May 2027 --> Feb 2025
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    Xtandi (enzalutamide capsule) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
    2ms
    A Study of GSK5764227 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=260, Not yet recruiting, GlaxoSmithKline | N=100 --> 260
    Enrollment change • Metastases
    |
    topotecan • GSK5764227
    3ms
    A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) (clinicaltrials.gov)
    P1/2, N=149, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • ifinatamab deruxtecan (DS-7300)
    3ms
    A Dual-Payload Antibody-Drug Conjugate Targeting CD276/B7-H3 Elicits Cytotoxicity and Immune Activation in Triple-Negative Breast Cancer. (PubMed, Cancer Res)
    Single-cell RNA-sequencing, multiplex cytokine analysis, and histology elucidated the impact of treatment on tumor cells and the immune landscape. This study suggests that the developed DualADC could represent a promising targeted chemo-immunotherapy for TNBC.
    Journal • IO biomarker
    |
    CD276 (CD276 Molecule)
    3ms
    BGB-C354-101: A First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=62, Recruiting, BeiGene | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr)
    3ms
    A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (IDeate-PanTumor02) (clinicaltrials.gov)
    P2, N=520, Recruiting, Daiichi Sankyo | N=260 --> 520 | Trial primary completion date: Dec 2026 --> Jul 2028
    Enrollment change • Trial primary completion date • Pan tumor • Metastases
    |
    ifinatamab deruxtecan (DS-7300)
    3ms
    First-in-human Study of DB-1419 for Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=360, Not yet recruiting, DualityBio Inc.
    New P1/2 trial • Metastases
    3ms
    A Study of GSK5764227 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=100, Not yet recruiting, GlaxoSmithKline
    New P1 trial • Metastases
    |
    topotecan • GSK5764227
    3ms
    A Study in Participants With Advanced Cancers Associated With Expression of DLL3 (MK-6070-001/HPN328-4001) (clinicaltrials.gov)
    P1/2, N=232, Recruiting, Harpoon Therapeutics, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) | N=162 --> 232 | Trial primary completion date: Jul 2025 --> Jan 2026
    Enrollment change • Trial primary completion date • Metastases
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    Tecentriq (atezolizumab) • ifinatamab deruxtecan (DS-7300) • MK-6070
    4ms
    A Study of HS-20093 vs Active Surveillance in Limited-Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=406, Not yet recruiting, Hansoh BioMedical R&D Company
    New P3 trial
    |
    GSK5764227
    4ms
    A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=162, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Hetronifly (serplulimab) • YL201
    4ms
    ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=610, Recruiting, Hansoh BioMedical R&D Company | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    Erbitux (cetuximab) • cisplatin • carboplatin • Xtandi (enzalutamide capsule) • Ariely (adebrelimab) • GSK5764227
    4ms
    ARTEMIS-008：HS-20093 Compared With Topotecan in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=460, Not yet recruiting, Hansoh BioMedical R&D Company
    New P3 trial
    |
    topotecan • GSK5764227
    5ms
    IDeate-2: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=468, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • Zepzelca (lurbinectedin) • ifinatamab deruxtecan (DS-7300) • Calsed (amrubicin)
    5ms
    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 | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    ifinatamab deruxtecan (DS-7300)
    6ms
    A Study of the ILB-3101 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=240, Not yet recruiting, Innolake Biopharm
    New P1 trial
    6ms
    BGB-C354-101: Phase 1 First-in-Human Study of BGB-C354 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=62, Not yet recruiting, BeiGene
    New P1 trial • Combination therapy • Metastases
    |
    Tevimbra (tislelizumab-jsgr)
    7ms
    A Study With ABBV-155 Alone and in Combination With Taxane Therapy in Adults With Relapsed and/or Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=169, Active, not recruiting, AbbVie | Trial completion date: Mar 2024 --> Dec 2024 | Trial primary completion date: Mar 2024 --> Dec 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 expression • HER-2 positive • EGFR mutation • HR positive • BRAF mutation • HER-2 negative • ALK mutation • ROS1 positive • HR positive + HER-2 negative • PTEN mutation + HR positive
    |
    paclitaxel • docetaxel • mirzotamab clezutoclax (ABBV-155)
    7ms
    A Phase 1 Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=162, Not yet recruiting, MediLink Therapeutics (Suzhou) Co., Ltd.
    New P1 trial • Combination therapy • Metastases
    |
    Hetronifly (serplulimab) • YL201
    7ms
    IDeate-2: A Study of Ifinatamab Deruxtecan Versus Treatment of Physician's Choice in Subjects With Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=468, Not yet recruiting, Daiichi Sankyo | Trial completion date: Jan 2028 --> Feb 2029 | Trial primary completion date: Jul 2026 --> Apr 2027
    Trial completion date • Trial primary completion date
    |
    topotecan • Zepzelca (lurbinectedin) • ifinatamab deruxtecan (DS-7300) • Calsed (amrubicin)
    7ms
    MGC018-SCLC: MGC018 in Patients With Relapsed or Refractory Extensive-Stage Small-Cell Lung Cancer (clinicaltrials.gov)
    P2, N=17, Recruiting, Georgetown University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    vobramitamab duocarmazine (MGC018)
    7ms
    A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=260, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open • Pan tumor • Metastases
    |
    ifinatamab deruxtecan (DS-7300)
    7ms
    A Study of IBI129 in Subjects With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    7ms
    A Study of I-DXd in Combination With Atezolizumab With or Without Carboplatin as First-Line Induction or Maintenance in Subjects With Extensive Stage-Small Cell Lung Cancer (IDeate-Lung03) (clinicaltrials.gov)
    P1/2, N=149, Not yet recruiting, Daiichi Sankyo
    New P1/2 trial • Combination therapy
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • ifinatamab deruxtecan (DS-7300)
    7ms
    Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
    P2, N=382, Active, not recruiting, MacroGenics | N=100 --> 382 | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Dec 2026 --> May 2027
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    abiraterone acetate • vobramitamab duocarmazine (MGC018)
    7ms
    IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=180, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1/2 trial • Metastases
    8ms
    ARTEMIS-101: A Study of HS-20093 Combinations in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=610, Not yet recruiting, Hansoh BioMedical R&D Company
    New P1 trial • Combination therapy • Metastases
    |
    Erbitux (cetuximab) • cisplatin • carboplatin • Xtandi (enzalutamide capsule) • Ariely (adebrelimab) • GSK5764227
    8ms
    A Study To Evaluate The Efficacy And Safety Of Ifinatamab Deruxtecan (I-DXD) In Subjects With Recurrent Or Metastatic Solid Tumors (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Daiichi Sankyo
    New P2 trial • Pan tumor • Metastases
    |
    ifinatamab deruxtecan (DS-7300)
    8ms
    Ifinatamab Deruxtecan (I-DXd) in Subjects With Pretreated Extensive-Stage Small Cell Lung Cancer (ES-SCLC) (clinicaltrials.gov)
    P2, N=180, Recruiting, Daiichi Sankyo | N=91 --> 180 | Trial completion date: Nov 2024 --> Jul 2025 | Trial primary completion date: May 2024 --> Jan 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    ifinatamab deruxtecan (DS-7300)
    8ms
    A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=278, Recruiting, MacroGenics | Trial completion date: Mar 2025 --> Mar 2026 | Trial primary completion date: Mar 2024 --> Mar 2025
    Trial completion date • Trial primary completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    vobramitamab duocarmazine (MGC018) • lorigerlimab (MGD019)
    8ms
    A Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of YL201 in Patients With mCRPC (clinicaltrials.gov)
    P2, N=100, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    abiraterone acetate • YL201
    9ms
    ARTEMIS-007: HS-20093 in Patients With Extensive Stage Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=0, Withdrawn, Hansoh BioMedical R&D Company | N=50 --> 0 | Not yet recruiting --> Withdrawn
    Enrollment change • Trial withdrawal
    |
    GSK5764227