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    DRUG CLASS:

    B7-H3-targeted antibody-drug conjugate

    Related drugs:
    4d
    A B7H3-targeting antibody-drug conjugate in advanced solid tumors: a phase 1/1b trial. (PubMed, Nat Med)
    YL201, a novel B7H3-targeting ADC, leverages a tumor microenvironment activable linker-payload platform, coupled with a novel topoisomerase 1 inhibitor via a protease-cleavable linker...Phase 3 clinical trials for patients with SCLC and NPC have already been initiated. ClinicalTrials.gov identifiers: NCT05434234 and NCT06057922 .
    P1 data • Journal
    |
    CD276 (CD276 Molecule)
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    YL201
    11d
    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, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • ifinatamab deruxtecan (DS-7300) • opevesostat (MK-5684)
    21d
    Reprogramming the Tumor Immune Microenvironment with ICAM-1-Targeted Antibody‒Drug Conjugates and B7-H3-CD3 Bispecific Antibodies. (PubMed, Adv Sci (Weinh))
    In addition, this innovative strategy promotes the accumulation of immune cells at metastasis sites and significantly impedes the progression of lung metastatic lesions. Overall, this study provides novel insights for reprogramming the TIM using novel immunotherapeutic strategies that leverage the synergistic effects of antibody-drug conjugates and bispecific antibodies.
    Journal
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    CD276 (CD276 Molecule) • ICAM1 (Intercellular adhesion molecule 1)
    25d
    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=138, Recruiting, Merck Sharp & Dohme LLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    26d
    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) | Trial completion date: Feb 2026 --> Jun 2027 | Trial primary completion date: Feb 2026 --> Jun 2027
    Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
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    Tecentriq (atezolizumab) • ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    28d
    Tamarack: A Study of Vobramitamab Duocarmazine in Participants With Metastatic Castration Resistant Prostate Cancer and Other Solid Tumors (clinicaltrials.gov)
    P2, N=192, Completed, MacroGenics | Active, not recruiting --> Completed
    Trial completion
    |
    Xtandi (enzalutamide) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
    1m
    ARTEMIS-102: HS-20093 Combinations in Patients with Advanced Metastatic Colorectal Cancer (clinicaltrials.gov)
    P1, N=560, Recruiting, Hansoh BioMedical R&D Company
    New P1 trial
    |
    Avastin (bevacizumab) • 5-fluorouracil • capecitabine • oxaliplatin • leucovorin calcium • GSK5764227
    1m
    A Phase III Study of YL201 in Recurrent or Metastatic Nasopharyngeal Carcinoma (clinicaltrials.gov)
    P3, N=400, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    gemcitabine • docetaxel • capecitabine • YL201
    1m
    A Phase III Study of YL201 in Relapsed Small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=438, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    topotecan • YL201
    1m
    A Study YL201 in Patients With Selected Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=990, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | N=640 --> 990 | Trial completion date: Oct 2027 --> Oct 2028
    Enrollment change • Trial completion date
    |
    YL201
    2ms
    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: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025
    Trial completion date • Trial primary completion date
    |
    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
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    paclitaxel • docetaxel • mirzotamab clezutoclax (ABBV-155)
    2ms
    A Study to Evaluate the Safety and Efficacy of 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=138, Not yet recruiting, Merck Sharp & Dohme LLC
    New P1/2 trial
    |
    ifinatamab deruxtecan (DS-7300) • gocatamig (MK-6070)
    2ms
    A Study of Ifinatamab Deruxtecan in Subjects With Pretreated Advanced or Metastatic Esophageal Squamous Cell Carcinoma (ESCC) (IDeate-Esophageal01) (clinicaltrials.gov)
    P3, N=510, Not yet recruiting, Daiichi Sankyo | Trial primary completion date: May 2029 --> Jun 2028
    Trial primary completion date
    |
    paclitaxel • docetaxel • irinotecan • ifinatamab deruxtecan (DS-7300)
    4ms
    A Study of GSK5764227 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=240, Recruiting, GlaxoSmithKline | Not yet recruiting --> Recruiting | Trial primary completion date: Dec 2026 --> Jul 2026
    Enrollment open • Trial primary completion date • Metastases
    |
    topotecan • GSK5764227
    4ms
    DB-1311-O-1001: A Study of DB-1311 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=450, Recruiting, DualityBio Inc. | N=280 --> 450 | Trial completion date: Apr 2025 --> Sep 2026 | Trial primary completion date: Apr 2025 --> Sep 2026
    Enrollment change • Trial completion date • Trial primary completion date • Metastases
    |
    EGFR (Epidermal growth factor receptor) • KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • MET (MET proto-oncogene, receptor tyrosine kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • NTRK1 (Neurotrophic tyrosine kinase, receptor, type 1) • NTRK3 (Neurotrophic tyrosine kinase, receptor, type 3) • NTRK2 (Neurotrophic tyrosine kinase, receptor, type 2) • CD276 (CD276 Molecule)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • KRAS G12C • BRAF V600 • NTRK1 fusion • NTRK3 fusion • NTRK2 fusion • ALK rearrangement • MET exon 14 mutation • ROS1 rearrangement • MET mutation • RET rearrangement • KRAS G12 • NTRK1 mutation
    |
    BNT324
    4ms
    IBI3001 in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=250, Recruiting, Innovent Biologics (Suzhou) Co. Ltd. | Not yet recruiting --> Recruiting | Phase classification: P1/2 --> P1 | N=180 --> 250 | Trial completion date: May 2027 --> Dec 2027 | Initiation date: May 2024 --> Dec 2024 | Trial primary completion date: May 2026 --> Dec 2026
    Enrollment open • Phase classification • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Metastases
    4ms
    Integrated molecular and functional characterization of the intrinsic apoptotic machinery identifies therapeutic vulnerabilities in glioma. (PubMed, Nat Commun)
    Accordingly, a machine-learning approach identifies a composite molecular and functional signature that best predicts responses of diverse intracranial glioma models to standard-of-care therapies combined with ABBV-155, a clinical drug targeting intrinsic apoptosis. This work demonstrates how complementary functional and molecular data can robustly predict therapy-induced cell death.
    Journal
    |
    TP53 (Tumor protein P53)
    |
    TP53 wild-type
    |
    mirzotamab clezutoclax (ABBV-155)
    4ms
    ARTEMIS-103: Phase 1b Study of HS-20093 Combinations in Patients with Bone and Soft Tissue Sarcoma. (clinicaltrials.gov)
    P1, N=448, Not yet recruiting, Hansoh BioMedical R&D Company
    New P1 trial • Combination therapy
    |
    Focus V (anlotinib) • epirubicin • Ariely (adebrelimab) • GSK5764227
    4ms
    CP-MGC018-02: A Study of MGC018 in Combination With MGD019 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=278, Active, not recruiting, MacroGenics | Recruiting --> Active, not recruiting | Trial completion date: Mar 2026 --> Jun 2025
    Enrollment closed • Trial completion date • Combination therapy • Checkpoint inhibition • Metastases
    |
    vobramitamab duocarmazine (MGC018) • lorigerlimab (MGD019)
    4ms
    YL201-INT-101-01: A Study of YL201 in Patients With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=196, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Trial completion date: Jul 2025 --> Oct 2027 | Trial primary completion date: Jul 2024 --> Apr 2027
    Trial completion date • Trial primary completion date • Metastases
    |
    YL201
    4ms
    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)
    4ms
    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
    4ms
    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)
    5ms
    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) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
    5ms
    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)
    5ms
    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
    5ms
    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
    5ms
    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)
    6ms
    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
    6ms
    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
    6ms
    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) • abiraterone acetate • vobramitamab duocarmazine (MGC018)
    6ms
    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
    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, Recruiting, Daiichi Sankyo | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • ifinatamab deruxtecan (DS-7300)
    7ms
    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)
    7ms
    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)
    7ms
    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)
    7ms
    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
    7ms
    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
    7ms
    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) • gocatamig (MK-6070)
    8ms
    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
    8ms
    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
    8ms
    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) • Ariely (adebrelimab) • GSK5764227