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    DRUG CLASS:

    CD3 modulator

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    Associations

    News

    Trials
    12ms
    A Study of GNC-077 in Patients With Locally Advanced or Metastatic Gastrointestinal Tumors and Other Solid Tumors (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial
    1year
    A Study of GNC-077 in Patients With Locally Advanced or Metastatic Breast Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1year
    A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=20, Recruiting, Sichuan Baili Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    1year
    A Study of GNC-077 in Patients With Locally Advanced or Metastatic Non-small-cell Lung Cancer and Other Solid Tumors (clinicaltrials.gov)
    P1, N=20, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.
    New P1 trial • Metastases
    almost2years
    HPN424-1001: Study of HPN424 in Patients With Advanced Prostate Cancer (clinicaltrials.gov)
    P1/2, N=104, Terminated, Harpoon Therapeutics | Active, not recruiting --> Terminated; Decision not to continue to the expansion portion of the study
    Trial termination • Metastases
    |
    HPN424
    2years
    Safety and Preliminary Efficacy Trial of BNT142 in Patients With CLDN6-positive Solid Tumors (clinicaltrials.gov)
    P1/2, N=288, Recruiting, BioNTech SE
    Trial completion date • Trial primary completion date • Metastases
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT142
    over2years
    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
    |
    obrixtamig (BI 764532)
    over2years
    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
    |
    obrixtamig (BI 764532) • ezabenlimab (BI 754091)
    over2years
    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
    |
    obrixtamig (BI 764532)
    over2years
    A phase I/II dose escalation trial with expansion cohorts to evaluate safety and preliminary efficacy of BNT142 in patients with prospectively confirmed claudin 6-positive solid tumors. (ASCO 2023)
    Additional sites will be opened in Europe, USA, and Asia in 2023. Clinical trial information: NCT05262530.
    P1/2 data • Clinical
    |
    CLDN6 (Claudin 6)
    |
    CLDN6 positive
    |
    BNT142
    over2years
    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
    |
    obrixtamig (BI 764532)