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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    1d
    HERTHENA-Lung01: Patritumab Deruxtecan in Subjects With Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P2, N=277, Active, not recruiting, Daiichi Sankyo | Trial completion date: Jul 2026 --> Jan 2027
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
    |
    patritumab deruxtecan (U3-1402)
    6d
    A Study of AK138D1 Alone or in Combination With Ivonescimab in Advanced Non-Small Cell Lung Cancer (clinicaltrials.gov)
    P1/2, N=265, Not yet recruiting, Akeso
    New P1/2 trial
    |
    carboplatin • Idafang (ivonescimab)
    6d
    A Phase I Study of CS5007 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=310, Not yet recruiting, CStone Pharmaceuticals
    New P1 trial • First-in-human
    8d
    A Phase I Study of JSKN021 in Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=199, Not yet recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P1 trial • First-in-human
    12d
    Study of IBI3005 Combination Therapy in Participants With Unresectable, Locally Advanced or Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=282, Not yet recruiting, Innovent Biologics (Suzhou) Co. Ltd.
    New P1/2 trial
    |
    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR L858R • EGFR exon 19 deletion
    |
    Avastin (bevacizumab) • Tagrisso (osimertinib) • carboplatin • Tyvyt (sintilimab) • limertinib (ASK120067)
    13d
    Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01) (clinicaltrials.gov)
    P2/3, N=500, Recruiting, Bristol-Myers Squibb | Trial completion date: May 2031 --> Nov 2030 | Trial primary completion date: Sep 2028 --> Dec 2028
    Trial completion date • Trial primary completion date
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    14d
    YL202 Versus Treatment of Physician's Choice in Patients With HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P3, N=376, Recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
    |
    gemcitabine • capecitabine • eribulin mesylate • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy) • BNT326
    21d
    A Clinical Study of SYS6023 Combination Therapy for Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=114, Not yet recruiting, CSPC Megalith Biopharmaceutical Co.,Ltd.
    New P2 trial
    |
    Ennituo (anbenitamab) • sirolimus for injection (albumin-bound) (SRL-HSA)
    22d
    Development of SDP0505: a first-in-class HER3 × c-Met bispecific ADC, demonstrates potent antitumor activity in EGFR TKI-resistant NSCLC, CRC, and beyond. (PubMed, Antib Ther)
    In HER3/c-Met dual-positive cell lines, SDP0505 demonstrated enhanced cell binding and internalization over the in-house synthesized U3-1402 analog...SDP0505 represents a novel HER3 × c-Met ADC with superior internalization and anti-tumor activity in preclinical models, especially in EGFR TKI-resistant PDX models. These results supported the initiation of a Phase I clinical trial in China.
    Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • MET (MET proto-oncogene, receptor tyrosine kinase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • MET expression
    |
    patritumab deruxtecan (U3-1402)
    22d
    A Phase II Clinical Study Evaluating the Combination Therapy of JS212 in Patients With Advanced Lung Cancer (clinicaltrials.gov)
    P2, N=864, Recruiting, Shanghai Junshi Bioscience Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Loqtorzi (toripalimab-tpzi) • AWT020
    25d
    YL202-INT-101-01: A Study of YL202 in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer and Breast Cancer (clinicaltrials.gov)
    P1, N=80, Active, not recruiting, MediLink Therapeutics (Suzhou) Co., Ltd. | Trial primary completion date: Dec 2025 --> Dec 2026
    Trial primary completion date • First-in-human
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • HR positive • HER-2 negative • EGFR L858R • EGFR exon 19 deletion • HR positive + HER-2 negative
    |
    BNT326
    28d
    A Study Comparing BL-B01D1 With Treatment of Physician's Choice in Patients With Locally Advanced or Metastatic Biliary Tract Cancer After Failure of Platinum-based Chemotherapy and PD-1/PD-L1 Monoclonal Antibody Therapy(PANKU-BTC01) (clinicaltrials.gov)
    P3, N=538, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
    |
    5-fluorouracil • capecitabine • oxaliplatin • izalontamab brengitecan (BL-B01D1) • levoleucovorin calcium