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    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    2d
    BL-B01D1-310: A Study Comparing BL-B01D1 With the Investigator's Choice of Chemotherapy in Patients With Platinum-resistant Recurrent Epithelial Ovarian Cancer(PANKU-GYN01) (clinicaltrials.gov)
    P3, N=384, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Platinum resistant
    |
    FOLR1 ( Folate receptor alpha )
    |
    paclitaxel • topotecan • izalontamab brengitecan (BL-B01D1)
    2d
    A Study of HDM2024 in Participants With Advanced Solid Tumors (clinicaltrials.gov)
    P1, N=63, Recruiting, Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd.
    New P1 trial
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    6d
    A Phase III Study of JSKN016 Versus Treatment of Physician's Choice in Patients With Triple-Negative Breast Cancer Who Have Failed Standard of Care (clinicaltrials.gov)
    P3, N=364, Recruiting, Jiangsu Alphamab Biopharmaceuticals Co., Ltd
    New P3 trial
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • Trodelvy (sacituzumab govitecan-hziy)
    7d
    ATR inhibition potentiates the antitumor efficacy of HER3-DXd in HER3-positive/HR-positive breast cancer by increasing DNA damage. (PubMed, Br J Cancer)
    Combining HER3-DXd with an ATR inhibitor could benefit HER3+/HR+ BC patients with both endocrine-sensitive and -resistant diseases.
    Journal
    |
    ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • CHEK1 (Checkpoint kinase 1)
    |
    HR positive • ERBB3 positive
    |
    tamoxifen • patritumab deruxtecan (U3-1402)
    9d
    BL-B01D1-302: A Study Comparing BL-B01D1 With Docetaxel in Patients With Unresectable Locally Advanced or Metastatic EGFR Wild-type Non-small Cell Lung Cancer(PANKU-Lung02) (clinicaltrials.gov)
    P3, N=698, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: May 2026 --> Dec 2026 | Trial primary completion date: May 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    EGFR (Epidermal growth factor receptor)
    |
    EGFR wild-type
    |
    docetaxel • izalontamab brengitecan (BL-B01D1)
    9d
    BL-B01D1-304: A Study Comparing BL-B01D1 With Topotecan in Patients With Recurrent Small Cell Lung Cancer(PANKU-Lung03) (clinicaltrials.gov)
    P3, N=722, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jul 2026 --> Dec 2026 | Trial primary completion date: Jul 2026 --> Dec 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    topotecan • izalontamab brengitecan (BL-B01D1)
    9d
    BL-B01D1-209: A Study of BL-B01D1 in Patients With Locally Advanced or Metastatic Chordoma (clinicaltrials.gov)
    P2, N=27, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting | N=40 --> 27
    Enrollment closed • Enrollment change
    |
    izalontamab brengitecan (BL-B01D1)
    10d
    TUXEDO-3: HER3-DXd in Breast Cancer and NSCLC Brain Metastases and Solid Tumor Leptomeningeal Disease (clinicaltrials.gov)
    P2, N=63, Completed, MedSIR | Active, not recruiting --> Completed
    Trial completion
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • TACSTD2 (Tumor Associated Calcium Signal Transducer 2)
    |
    HER-2 positive • EGFR mutation • HER-2 expression • EGFR T790M
    |
    patritumab deruxtecan (U3-1402)
    10d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE
    New P1/2 trial
    |
    itraconazole • pumitamig (BNT327) • BNT326
    10d
    BNT326-01: A Clinical Study to Test if an Investigational Treatment Called BNT326 is Safe and Potentially Beneficial When Used Alone or in Combination With Other Investigational Treatments Such as BNT327, for People With Advanced Malignant Tumors (clinicaltrials.gov)
    P1/2, N=280, Recruiting, BioNTech SE | N=172 --> 280
    Enrollment change
    |
    itraconazole • pumitamig (BNT327) • BNT326
    14d
    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
    |
    EGFR mutation • EGFR L858R • EGFR exon 19 deletion • EGFR T790M
    |
    JS111
    15d
    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
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • ABCG2 (ATP Binding Cassette Subfamily G Member 2)
    |
    EGFR expression
    |
    izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)