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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    1d
    JS212 Plus JS111 in EGFR-Mutant Advanced NSCLC: A Phase II Study (clinicaltrials.gov)
    P2, N=35, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
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    JS111
    2d
    EGFR- and HER3-targeted bispecific antibody-drug conjugate demonstrates anti-tumor activity in metastatic castration-resistant prostate cancer. (PubMed, J Clin Invest)
    Izalontamab brengitecan (Iza-bren; BL-B01D1) is a bispecific ADC targeting EGFR and HER3 that has demonstrated activity in other malignancies. Importantly, tumor tissue obtained at progression after BL-B01D1 treatment confirmed ABCG2 upregulation, validating a clinically relevant resistance mechanism. These findings support BL-B01D1 as a promising therapeutic strategy in mCRPC and nominate ABCG2 as a rational target for overcoming resistance.
    Journal
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    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
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    EGFR expression
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    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    2d
    A Phase 1/2 Study of KHN922 for Injection (clinicaltrials.gov)
    P1/2, N=276, Not yet recruiting, Chengdu Kanghong Biotech Co., Ltd.
    New P1/2 trial
    2d
    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: Jan 2026 --> Jul 2026
    Trial completion date
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    ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
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    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • ROS1 fusion
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    patritumab deruxtecan (U3-1402)
    4d
    A First-in-human, Dose Escalation and Indication Expansion Study of BNT3212 as Monotherapy or in Combination With BNT327 in Adults With Advanced Solid Tumors (clinicaltrials.gov)
    P1/2, N=375, Recruiting, BioNTech SE | Trial completion date: Mar 2028 --> Aug 2028
    Trial completion date • First-in-human
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    pumitamig (BNT327)
    9d
    DB-1310-O-1001: A Phase 1/2a Study of DB-1310 in Advanced/Metastatic Solid Tumors (clinicaltrials.gov)
    P1/2, N=1000, Recruiting, DualityBio Inc. | Trial completion date: Aug 2026 --> Apr 2028 | Trial primary completion date: Aug 2026 --> Dec 2027
    Trial completion date • Trial primary completion date • First-in-human
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    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
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    Herceptin (trastuzumab) • Tagrisso (osimertinib) • capecitabine • DB-1310
    9d
    JS212 Combination Therapies in Metastatic Colorectal Cancer (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
    |
    capecitabine • oxaliplatin
    10d
    Evaluation of JSKN016 Combination Therapy in Subjects With NSCLC (clinicaltrials.gov)
    P1, N=288, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd | Not yet recruiting --> Recruiting
    Enrollment open
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    Keytruda (pembrolizumab) • carboplatin • docetaxel • Tevimbra (tislelizumab-jsgr) • Ivesa (firmonertinib) • Yidafan (ivonescimab)
    11d
    A Study Comparing BL-B01D1 Combined With Tislelizumab Versus Platinum-containing Chemotherapy Combined With Tislelizumab as First-line Treatment in Patients With Extensive-stage Small Cell Lung Cance (clinicaltrials.gov)
    P3, N=562, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P3 trial
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    carboplatin • Tevimbra (tislelizumab-jsgr) • etoposide IV • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    13d
    Study on the Efficacy and Safety of JSKN016 as Neoadjuvant Therapy in Resectable Stage II-III Non-small Cell Lung Cancer Patients (clinicaltrials.gov)
    P2, N=54, Not yet recruiting, Shanghai Pulmonary Hospital, Shanghai, China
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase)
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    EGFR L858R • EGFR exon 19 deletion • ALK fusion
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    carboplatin • Loqtorzi (toripalimab-tpzi)
    13d
    The Effect of HER3 Expression on Prognosis in EGFR-Mutant Non-Small Cell Lung Cancer: A Retrospective Real-World Study. (PubMed, Medicina (Kaunas))
    Of 52 patients (55.8% female; mean age 64.5 years), 59.6% received chemotherapy and 40.4% received an EGFR TKI as first-line treatment; erlotinib constituted 71.2% of targeted therapies. These results suggest that HER3 expression may warrant further investigation as a candidate biomarker for treatment sequencing decisions and as a potential therapeutic target in EGFR-mutant NSCLC. Prospective studies evaluating chemotherapy-TKI sequencing and HER3-directed agents such as patritumab deruxtecan (HER3-DXd) in HER3-positive patients are needed to confirm these preliminary observations.
    Retrospective data • Journal • Real-world evidence
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    EGFR (Epidermal growth factor receptor) • HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    EGFR mutation • EGFR expression • ERBB3 positive
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    erlotinib • patritumab deruxtecan (U3-1402)
    20d
    A Study Evaluating the Safety and Efficacy of JS212 Combination Therapy in Patients With Advanced Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P2, N=280, Not yet recruiting, Shanghai Junshi Bioscience Co., Ltd.
    New P2 trial
    |
    5-fluorouracil • Loqtorzi (toripalimab-tpzi)