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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 BioTherap
    Drug class:
    CD3 agonist, DLL3 inhibitor
    Related drugs:
    22d
    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, Recruiting, Boehringer Ingelheim | Trial completion date: Aug 2026 --> Apr 2027 | Trial primary completion date: Jul 2026 --> Feb 2027
    Trial completion date • Trial primary completion date
    |
    cisplatin • carboplatin • etoposide IV • obrixtamig (BI 764532)
    22d
    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 | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532)
    1m
    A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer (clinicaltrials.gov)
    P1, N=12, Recruiting, Boehringer Ingelheim | Trial completion date: Jul 2026 --> Nov 2026 | Trial primary completion date: Jan 2026 --> May 2026
    Trial completion date • Trial primary completion date
    |
    obrixtamig (BI 764532)
    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 | Phase classification: P1/2 --> P1 | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2025
    Phase classification • Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    2ms
    A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for DLL3 (clinicaltrials.gov)
    P1, N=300, Recruiting, Boehringer Ingelheim | Trial completion date: Dec 2025 --> Feb 2027 | Trial primary completion date: Sep 2025 --> Aug 2026
    Trial completion date • Trial primary completion date • First-in-human
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    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 | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • etoposide IV • obrixtamig (BI 764532)
    3ms
    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)
    P1/2, N=45, Active, not recruiting, Boehringer Ingelheim | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    4ms
    Phase I Dose-Escalation Results for the Delta-Like Ligand 3/CD3 IgG-Like T-Cell Engager Obrixtamig (BI 764532) in Patients With Delta-Like Ligand 3+ Small Cell Lung Cancer or Neuroendocrine Carcinomas. (PubMed, J Clin Oncol)
    The demonstrated tolerability and efficacy of obrixtamig regimens, administered as step-up followed by target doses of 90-1,080 μg/kg (once weekly or once every 3 weeks), in patients with heavily pretreated DLL3-positive tumors support further exploration in SCLC, epNEC, and LCNEC-L.
    P1 data • Journal
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 positive
    |
    obrixtamig (BI 764532)
    5ms
    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=47, Recruiting, Boehringer Ingelheim | Trial primary completion date: Aug 2025 --> Dec 2025
    Trial primary completion date
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • etoposide IV • obrixtamig (BI 764532)
    8ms
    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=20, Recruiting, Boehringer Ingelheim | Trial completion date: Sep 2025 --> Mar 2026
    Trial completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532)
    8ms
    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)
    P1/2, N=45, Active, not recruiting, Boehringer Ingelheim | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    8ms
    DareonTM: 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=174, Recruiting, Boehringer Ingelheim | Active, not recruiting --> Recruiting | N=120 --> 174
    Enrollment open • Enrollment change
    |
    obrixtamig (BI 764532)