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    DRUG:

    BNT321

    i
    Other names: BNT321, HuMab-5B1, 5B1-(sLeA)-therapeutic, anti-sialyl Lewisa antibody, MVT 5873, MVT-5873, BNT-321, BNT 321, MVT5873
    Associations

    News

    Trials
    Company:
    BioNTech
    Drug class:
    CA19-9 inhibitor
    Related drugs:
    Associations

    News

    Trials
    3ms
    MV-0715-CP-001.01: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=118, Active, not recruiting, BioNTech Research & Development, Inc. | Recruiting --> Active, not recruiting | N=264 --> 118
    Enrollment closed • Enrollment change
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • BNT321
    7ms
    Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov)
    P1, N=4, Active, not recruiting, Memorial Sloan Kettering Cancer Center | Recruiting --> Active, not recruiting | N=15 --> 4
    Enrollment closed • Enrollment change
    |
    BNT321
    9ms
    MV-0715-CP-001.01: Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=264, Recruiting, BioNTech Research & Development, Inc. | Trial completion date: Feb 2024 --> Oct 2026 | Trial primary completion date: Feb 2024 --> Aug 2024
    Trial completion date • Trial primary completion date
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • BNT321
    10ms
    Study of a New Technique for Imaging Pancreatic Cancer (clinicaltrials.gov)
    P1, N=15, Recruiting, Memorial Sloan Kettering Cancer Center | Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025
    Trial completion date • Trial primary completion date
    |
    BNT321
    11ms
    Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=264, Recruiting, BioNTech Research & Development, Inc.
    Trial completion date • Trial primary completion date
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • BNT321
    11ms
    Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=300, Recruiting, BioNTech SE
    Trial completion date • Trial initiation date • Trial primary completion date
    |
    oxaliplatin • irinotecan • BNT321
    12ms
    BNT321, a novel monoclonal antibody targeting sialyl Lewis A: Phase 1 monotherapy and combination with mFOLFIRINOX in patients with advanced CA19-9 expressing cancers. (ASCO-GI 2024)
    BNT321 and BNT321 + mFFX MTDs were 2 mg/kg and 1 kg/kg, respectively. DLTs were hepatic AST, ALT and T bilirubin elevations which were generally cycle 1 and did not preclude subsequent BNT321 at reduced dose. BNT321 monotherapy resulted in disease stabilization and prolonged time on study (> 90 days for > 20%) in pts with advanced line, metastatic PDAC and other CA19-9+ cancers.
    Clinical • P1 data • Metastases
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    irinotecan • BNT321
    1year
    Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P1/2, N=300, Recruiting, BioNTech SE | Not yet recruiting --> Recruiting | Phase classification: P2 --> P1/2
    Enrollment open • Phase classification
    |
    oxaliplatin • irinotecan • BNT321
    1year
    Safety, Tolerability, and Efficacy of mFOLFIRINOX ± BNT321 as Adjuvant Therapy Following Curative Resection in Patients With Pancreatic Adenocarcinoma (clinicaltrials.gov)
    P2, N=300, Not yet recruiting, BioNTech SE
    New P2 trial
    |
    oxaliplatin • irinotecan • BNT321
    almost2years
    Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=264, Recruiting, BioNTech Research & Development, Inc. | N=162 --> 264
    Enrollment change
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    gemcitabine • 5-fluorouracil • albumin-bound paclitaxel • irinotecan • leucovorin calcium • BNT321
    2years
    Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov)
    P1, N=7, Suspended, BioNTech Research & Development, Inc. | Trial completion date: Sep 2022 --> Feb 2023 | Trial primary completion date: Sep 2022 --> Feb 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    BNT321 • MVT-1075
    over2years
    Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov)
    P1, N=7, Suspended, BioNTech Research & Development, Inc. | Trial completion date: Dec 2021 --> Sep 2022 | Trial primary completion date: Dec 2021 --> Sep 2022
    Trial completion date • Trial primary completion date • Combination therapy
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    BNT321 • MVT-1075
    almost3years
    Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=162, Recruiting, BioNTech Research & Development, Inc. | Trial completion date: Jan 2023 --> Feb 2024 | Trial primary completion date: Jan 2023 --> Feb 2024
    Trial completion date • Trial primary completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    5-fluorouracil • leucovorin calcium • BNT321
    3years
    Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1 (clinicaltrials.gov)
    P1, N=15, Terminated, BioNTech Research & Development, Inc. | Active, not recruiting --> Terminated; Sponsor decision
    Clinical • Trial termination
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    BNT321
    over3years
    Study of HuMab-5B1 (MVT-5873) in Subjects With Pancreatic Cancer or Other Cancer Antigen 19-9 (CA19-9) Positive Malignancies (clinicaltrials.gov)
    P1, N=162, Recruiting, BioNTech Research & Development, Inc. | N=108 --> 162
    Clinical • Enrollment change
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    5-fluorouracil • leucovorin calcium • BNT321
    over3years
    Study of 177Lu Human Monoclonal Antibody 5B1 (MVT-1075) in Combination With a Blocking Dose of MVT-5873 as Radioimmunotherapy (clinicaltrials.gov)
    P1, N=7, Suspended, BioNTech Research & Development, Inc. | Trial completion date: Dec 2020 --> Dec 2021 | Active, not recruiting --> Suspended | Trial primary completion date: Dec 2020 --> Dec 2021
    Clinical • Trial completion date • Trial suspension • Trial primary completion date • Combination therapy
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    BNT321 • MVT-1075
    over3years
    Phase 1 Imaging Study of 89Zr-DFO-HuMab-5B1 With HuMab-5B1 (clinicaltrials.gov)
    P1, N=15, Active, not recruiting, BioNTech Research & Development, Inc. | Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
    Clinical • Trial completion date • Trial primary completion date
    |
    CA 19-9 (Cancer antigen 19-9)
    |
    BNT321