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    DRUG:

    BI 764532

    i
    Other names: BI 764532, OBT620
    Company:
    Boehringer Ingelheim, Oxford BioTherap
    Drug class:
    CD3 agonist, DLL3 inhibitor
    Related drugs:
    2ms
    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 | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BI 764532
    3ms
    A Study to Test How Well Different Doses of 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=30, Recruiting, Boehringer Ingelheim | Trial completion date: Oct 2024 --> Feb 2025 | Trial primary completion date: Oct 2024 --> Feb 2025
    Trial completion date • Trial primary completion date • Combination therapy
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532 • ezabenlimab (BI 754091)
    4ms
    DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan (clinicaltrials.gov)
    P1, N=44, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    topotecan • BI 764532
    4ms
    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=60, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • etoposide IV • BI 764532
    4ms
    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 | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    cisplatin • carboplatin • etoposide IV • BI 764532
    5ms
    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=35, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    5ms
    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=250, Recruiting, Boehringer Ingelheim | Trial completion date: Sep 2024 --> Jul 2025
    Trial completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    6ms
    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=35, Not yet recruiting, Boehringer Ingelheim | Trial completion date: Nov 2025 --> Aug 2026 | Trial primary completion date: Oct 2025 --> Aug 2026
    Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    6ms
    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, Not yet recruiting, Boehringer Ingelheim
    New P1 trial • Combination therapy • Metastases
    |
    cisplatin • carboplatin • etoposide IV • BI 764532
    6ms
    A Phase 1b, open-label, dose-escalation trial of the delta-like ligand 3 (DLL3)/CD3 IgG-like T cell engager, BI 764532, in patients with DLL3-positive glioma (SNO 2023)
    Key exclusion criteria: extracranial metastatic or leptomeningeal disease; previous treatment with DLL3-targeting therapies; prior treatment with bevacizumab/other anti-VEGF/anti-angiogenic treatment ≤6 months prior to first administration of BI 764532; persistent toxicity from previous treatments that has not resolved to ≤CTCAE Grade 1; diagnosis of immunodeficiency, or intake of immunosuppressive therapy ≤7 days prior to first administration of BI 764532. Primary endpoints: dose-limiting toxicities (DLTs) during the maximum tolerated dose evaluation period (escalation phase); DLTs during the entire treatment period (expansion phase). Other objectives include pharmacokinetics, pharmacodynamics, preliminary efficacy and evaluation of DLL3 as a potential biomarker.
    Clinical • P1 data
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 positive
    |
    Avastin (bevacizumab) • BI 764532
    6ms
    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=60, Not yet recruiting, Boehringer Ingelheim | Trial completion date: Oct 2025 --> Jun 2026
    Trial completion date • Metastases
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • etoposide IV • BI 764532
    7ms
    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=55, Not yet recruiting, Boehringer Ingelheim
    New P1 trial • Metastases
    |
    cisplatin • Tecentriq (atezolizumab) • carboplatin • Imfinzi (durvalumab) • etoposide IV • BI 764532
    7ms
    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=120, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open
    |
    BI 764532
    7ms
    Phase I trial of the DLL3/CD3 IgG-like T cell engager BI 764532 in patients (pts) with DLL3+ tumors: Focus on Asian pts (ESMO Asia 2023)
    Promising efficacy was observed in SCLC, epNEC and LCNEC. The tolerability and efficacy of BI 764532 was similar in Asian pts and the overall population.
    Clinical • P1 data
    |
    RB1 (RB Transcriptional Corepressor 1) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    BI 764532
    8ms
    DareonTM-5: An open-label Phase II trial of BI 764532, a DLL3-targeting T cell engager, in patients with relapsed/refractory small cell lung cancer or other neuroendocrine carcinomas (AACR-NCI-EORTC 2023)
    No abstract available
    Clinical • P2 data • Late-breaking abstract
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    BI 764532
    9ms
    DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan (clinicaltrials.gov)
    P1, N=44, Not yet recruiting, Boehringer Ingelheim
    New P1 trial • Combination therapy
    |
    PD-L1 (Programmed death ligand 1)
    |
    topotecan • BI 764532
    9ms
    Phase I trial of the DLL3/CD3 IgG-like T cell engager BI 764532 in patients (pts) with DLL3-positive (+) tumours: Focus on neuroendocrine carcinomas (ESMO 2023)
    Promising efficacy was observed in pts with epNEC. The study is ongoing.
    Clinical • P1 data
    |
    PD-L1 (Programmed death ligand 1) • RB1 (RB Transcriptional Corepressor 1) • PD-1 (Programmed cell death 1) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 positive
    |
    BI 764532
    10ms
    Phase I, non-randomised, open-label, multi-centre dose escalation trial of BI 764532 (DLL3/CD3 IgG-like T cell engager [TcE]) + ezabenlimab (anti-PD-1 antibody) in patients (pts) with small cell lung cancer (SCLC) and other neuroendocrine carcinomas (NECs) expressing DLL3 (ESMO 2023)
    In the dose escalation part, the primary endpoint is dose-limiting toxicity (DLT) occurrence in the MTD evaluation period; secondary endpoints include DLT occurrence in the on-treatment period, objective response and pharmacokinetics. Enrolment is ongoing.
    Clinical
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression • DLL3 positive
    |
    BI 764532 • ezabenlimab (BI 754091)
    10ms
    Phase I Dose Escalation Trial Of The DLL3/CD3 Igg-Like T Cell Engager BI 764532 In Patients with DLL3+ Tumors: Focus on SCLC (IASLC-WCLC 2023)
    BI 764532 showed clinically manageable tolerability and MTD has not been reached at the doses administered to date. Promising efficacy has been observed in patients with heavily pre-treated SCLC. The study is ongoing; updated data will be presented.
    Clinical • P1 data
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    BI 764532
    10ms
    Emerging therapies targeting the delta-like ligand 3 (DLL3) in small cell lung cancer. (PubMed, J Hematol Oncol)
    First, we discuss the clinical experience with rovalpituzumab tesirine (Rova-T), a DLL3-targeting ADC, the development of which was halted due to a lack of efficacy in phase 3 studies, with a view to understanding the lessons that can be garnered for the rapidly evolving therapeutic landscape in SCLC. We then review preclinical and clinical data for several DLL3-targeting agents that are currently in development, including the TCE molecules-tarlatamab (formerly known as AMG 757), BI 764532, and HPN328-and the CAR T-cell therapy AMG 119. We conclude with a discussion of the future challenges and opportunities for DLL3-targeting therapies, including the utility of DLL3 as a biomarker for patient selection and disease progression, and the potential of rational combinatorial approaches that can enhance efficacy.
    Review • Journal • IO biomarker
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    BI 764532 • Rova-T (rovalpituzumab tesirine) • tarlatamab (AMG 757) • MK-6070
    11ms
    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=193, Recruiting, Boehringer Ingelheim | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Apr 2024 --> Sep 2024
    Trial completion date • Trial primary completion date
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    11ms
    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=35, Not yet recruiting, Boehringer Ingelheim
    New P1 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    11ms
    A Study to Test How Well Different Doses of 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=30, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532 • ezabenlimab (BI 754091)
    11ms
    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=120, Not yet recruiting, Boehringer Ingelheim
    New P2 trial
    |
    BI 764532
    11ms
    A Study to Test How Well Different Doses of 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=30, Not yet recruiting, Boehringer Ingelheim
    New P1/2 trial • Combination therapy
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532 • ezabenlimab (BI 754091)
    12ms
    A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3). (clinicaltrials.gov)
    P1, N=190, Recruiting, Boehringer Ingelheim | N=110 --> 190
    Enrollment change
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    1year
    First-in-human dose-escalation trial of BI 764532, a delta-like ligand 3 (DLL3)/CD3 IgG-like T-cell engager in patients (pts) with DLL3-positive (DLL3+) small-cell lung cancer (SCLC) and neuroendocrine carcinoma (NEC). (ASCO 2023)
    BI 764532 showed clinically manageable tolerability and MTD has not been reached at the doses administered to date. Promising efficacy has been observed, not only in SCLC but also in difficult to treat entities such as NEC and LCNEC. The study is ongoing; updated data will be presented.
    Clinical • P1 data
    |
    PD-L1 (Programmed death ligand 1) • RB1 (RB Transcriptional Corepressor 1) • PD-1 (Programmed cell death 1) • DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 positive
    |
    BI 764532
    almost2years
    Phase I trial of the DLL3/CD3 bispecific T-cell engager BI 764532 in DLL3-positive small-cell lung cancer and neuroendocrine carcinomas. (PubMed, Future Oncol)
    Here, we describe the study design of a first-in-human, phase I, multicenter, open-label, non-randomized, dose-escalation study in patients with SCLC or other DLL3-positive neuroendocrine carcinomas. The study will determine the maximum tolerated dose and evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of BI 764532 monotherapy.
    P1 data • Review • Journal
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    BI 764532
    3years
    [VIRTUAL] A phase I, open-label, dose-escalation trial of BI 764532, a DLL3/CD3 bispecific antibody, in patients (pts) with small cell lung carcinoma (SCLC) or other neuroendocrine neoplasms expressing DLL3. (ASCO 2021)
    For Phase Ia, ̃160 pts will be screened and 110 pts accrued . As of Feb 2021, pts are being recruited and treated in early dose escalation cohorts.
    Clinical • PD(L)-1 Biomarker • IO biomarker
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    almost4years
    A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3). (clinicaltrials.gov)
    P1, N=110, Recruiting, Boehringer Ingelheim | Not yet recruiting --> Recruiting
    Clinical • Enrollment open
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532
    almost4years
    A Study to Test Different Doses of BI 764532 in Patients With Small Cell Lung Cancer and Other Neuroendocrine Tumours That Are Positive for Delta-Like Ligand 3 (DLL3). (clinicaltrials.gov)
    P1, N=110, Not yet recruiting, Boehringer Ingelheim
    Clinical • New P1 trial
    |
    DLL3 (Delta Like Canonical Notch Ligand 3)
    |
    DLL3 expression
    |
    BI 764532