^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG CLASS:

    HER3-targeted antibody-drug conjugate

    Related drugs:
    14d
    Determinants of long-term response to patritumab deruxtecan in breast cancer patient-derived xenografts. (PubMed, NPJ Precis Oncol)
    Basal-like PAM50 intrinsic subtype, limited prior exposure to chemotherapy and intrinsic sensitivity to the TOP1i irinotecan were associated with long-term response. Long-term responders exhibited persistent DNA damage and lacked early transcriptional activation of the G2/M cell cycle checkpoint that allow for DNA repair and RNA-DNA hybrid (R-loop) resolution, in parallel resulting in immune pathways transcriptional activation. Notably, characteristics linked to long-term response were primarily associated with the TOP1i payload activity.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    Prosigna™ Breast Cancer Prognostic Gene Signature Assay
    |
    irinotecan • patritumab deruxtecan (U3-1402)
    17d
    Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02) (clinicaltrials.gov)
    P1/2, N=180, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Jul 2028 --> Dec 2028 | Trial primary completion date: Jul 2028 --> Dec 2028
    Trial completion date • Trial primary completion date • Pan tumor
    |
    patritumab deruxtecan (U3-1402)
    18d
    BL-B01D1-204-13: A Study of BL-B01D1+TKI±Pembrolizumab in Patients With Locally Advanced or Metastatic Renal Cancer (clinicaltrials.gov)
    P2, N=260, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | N=120 --> 260
    Enrollment change
    |
    Keytruda (pembrolizumab) • Lenvima (lenvatinib) • Inlyta (axitinib) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-204-11: A Study of BL-B01D1 + Pembrolizumab ± Bevacizumab in Patients With Recurrent or Metastatic Cervical Cancer and Endometrial Cancer (clinicaltrials.gov)
    P2, N=206, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Keytruda (pembrolizumab) • Avastin (bevacizumab) • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-305: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Recurrent or Metastatic Esophageal Squamous Cell Carcinoma (clinicaltrials.gov)
    P3, N=497, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    paclitaxel • docetaxel • irinotecan • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-307: A Study Comparing BL-B01D1 With Chemotherapy of Physician's Choice in Patients With Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer (clinicaltrials.gov)
    P3, N=418, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • capecitabine • Halaven (eribulin mesylate) • vinorelbine tartrate • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    BL-B01D1-301: A Study Comparing BL-B01D1 With Platinum Based Chemotherapy in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (clinicaltrials.gov)
    P3, N=432, Active, not recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    18d
    A Multicentre,Study of IBI133 in Subjects WithUnresectable, Locally Advanced or Metastatic SolidTumours (clinicaltrials.gov)
    P1/2, N=19, Completed, Innovent Biologics (Suzhou) Co. Ltd. | Recruiting --> Completed | N=120 --> 19 | Trial completion date: Dec 2026 --> Feb 2025 | Trial primary completion date: Dec 2025 --> Feb 2025
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
    23d
    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=596, Recruiting, Bristol-Myers Squibb | Not yet recruiting --> Recruiting
    Enrollment open
    |
    cisplatin • carboplatin • pemetrexed • izalontamab (SI-B001) • izalontamab brengitecan (BL-B01D1)
    1m
    Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of non-small-cell lung cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Oncol)
    HER3-DXd showed promising clinical activity in patients with advanced NSCLC and active brain metastases, and could represent a novel treatment option in this setting.
    P2 data • Journal
    |
    KRAS (KRAS proto-oncogene GTPase) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    patritumab deruxtecan (U3-1402)
    1m
    Patritumab deruxtecan (HER3-DXd) in patients with active brain metastases of breast cancer (TUXEDO-3): a multicentre, single-arm, phase 2 trial. (PubMed, Lancet Oncol)
    HER3-DXd showed promising clinical activity in patients with metastatic breast cancer and active brain metastases, and could offer a novel therapeutic option in this setting.
    P2 data • Journal
    |
    HER-2 (Human epidermal growth factor receptor 2) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3)
    |
    HER-2 positive
    |
    patritumab deruxtecan (U3-1402)
    1m
    HERTHENA-Breast-01: Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) (clinicaltrials.gov)
    P1/2, N=81, Recruiting, Merck Sharp & Dohme LLC | Trial completion date: Sep 2029 --> Apr 2030 | Trial primary completion date: Sep 2029 --> Apr 2030
    Trial completion date • Trial primary completion date
    |
    Perjeta (pertuzumab) • Tukysa (tucatinib) • patritumab deruxtecan (U3-1402) • Herzuma (trastuzumab-pkrb) • Trazimera (trastuzumab-qyyp)