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    DRUG:

    obrixtamig (BI 764532)

    i
    Other names: BI 764532, OBT620, BI-764532, OBT-620, BI764532, OBT 620
    Company:
    Boehringer Ingelheim, Oxford BioTherapeutics
    Drug class:
    CD3 agonist, DLL3 inhibitor
    Related drugs:
    2d
    DAREON-7: DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers (clinicaltrials.gov)
    P1, N=55, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • carboplatin • etoposide IV • obrixtamig (BI 764532)
    9d
    A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With a Tumour in the Brain That is Positive for DLL3 (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2026 --> Sep 2027 | Trial primary completion date: May 2026 --> Aug 2027
    Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532)
    26d
    DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy (clinicaltrials.gov)
    P3, N=390, Not yet recruiting, Boehringer Ingelheim | Trial completion date: May 2030 --> Dec 2029
    Trial completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    carboplatin • etoposide IV • obrixtamig (BI 764532)
    29d
    1438-0011: A study in people with advanced extrapulmonary neuroendocrine cancer to compare obrixtamig plus carboplatin and etoposide treatment with standard chemotherapy. (2025-523869-22-00)
    P2/3, N=74, Not yet recruiting, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
    New P2/3 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    carboplatin • etoposide IV • obrixtamig (BI 764532)
    29d
    1438-0012: DAREON-Lung-1: A study in people with advanced small cell lung cancer to compare obrixtamig plus atezolizumab, carboplatin, and etoposide treatment with standard chemotherapy. (2025-520565-51-00)
    P2/3, N=105, Not yet recruiting, Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.
    New P2/3 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • obrixtamig (BI 764532) • Actemra IV (tocilizumab)
    1m
    ALPINE 2: A Trial for the Treatment of Advanced Large-Cell Neuroendocrine Cancer of the Lung (clinicaltrials.gov)
    P2, N=75, Not yet recruiting, Technische Universität Dresden
    New P2 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    carboplatin • obrixtamig (BI 764532)
    1m
    DAREON-5: DAREON™-5: A Study to Test Whether Different Doses of BI 764532 Help People With Small Cell Lung Cancer or Other Neuroendocrine Cancers (clinicaltrials.gov)
    P2, N=204, Recruiting, Boehringer Ingelheim | N=109 --> 204
    Enrollment change
    |
    PD-L1 (Programmed death ligand 1) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    obrixtamig (BI 764532)
    1m
    Emerging therapies and translational advances in small cell lung cancer: Overcoming resistance. (PubMed, Respir Investig)
    Platinum-etoposide has long been the standard first-line therapy, and the recent incorporation of immune checkpoint inhibitors (ICIs) such as atezolizumab (IMpower133) and durvalumab (CASPIAN, ADRIATIC) has modestly improved survival, including a new role for durvalumab as a consolidation therapy in limited-stage SCLC...Emerging approaches include DLL3-directed bispecific T-cell engagers (BiTEs), such as tarlatamab and obrixtamig, which have shown promising efficacy in relapsed disease, and next-generation antibody-drug conjugates (ADCs) targeting DLL3, B7-H3, TROP2, and SEZ6...Future therapeutic efforts will require biomarker-driven strategies that incorporate molecular subtyping (ASCL1, NEUROD1, POU2F3, and YAP1) and immune profiling to facilitate precise treatment selection. Combining ICIs, BiTEs, ADCs, and cellular or radioligand therapies in rational, evidence-based regimens represents a promising avenue to improve outcomes in this historically intractable disease.
    Review • Journal • PD(L)-1 Biomarker • IO biomarker
    |
    CD276 (CD276 Molecule) • DLL3 (Delta Like Canonical Notch Ligand 3) • YAP1 (Yes associated protein 1) • POU2F3 (POU Class 2 Homeobox 3) • SEZ6 (Seizure Related 6 Homolog) • ASCL1 (Achaete-Scute Family BHLH Transcription Factor 1) • NEUROD1 (Neuronal Differentiation 1)
    |
    Tecentriq (atezolizumab) • Imfinzi (durvalumab) • etoposide IV • obrixtamig (BI 764532) • Imdelltra (tarlatamab-dlle)
    1m
    A Study to Test How Well Different Doses of Obrixtamig (BI 764532) in Combination With Ezabenlimab Are Tolerated by People With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov)
    P1, N=45, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Jun 2026 --> Dec 2026
    Trial completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    2ms
    A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy (clinicaltrials.gov)
    P3, N=390, Not yet recruiting, Boehringer Ingelheim
    New P3 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    carboplatin • etoposide IV • obrixtamig (BI 764532)
    2ms
    DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy (clinicaltrials.gov)
    P3, N=670, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    VENTANA DLL3 (SP347) Assay
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • obrixtamig (BI 764532)
    2ms
    DAREON-8: DAREONᵀᴹ-8: A Study to Test How Well Different Doses of BI 764532 in Addition to Standard of Care Are Tolerated by People With Advanced Small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=46, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Sep 2026 --> Apr 2027
    Trial completion date
    |
    Tecentriq (atezolizumab) • carboplatin • etoposide IV • obrixtamig (BI 764532)