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Clinical trials for Bispecific antibodies

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

  • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).


    The EU Clinical Trials Register currently displays   44356   clinical trials with a EudraCT protocol, of which   7382   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    38 result(s) found for: Bispecific antibodies. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2017-002400-26 Sponsor Protocol Number: 64407564MMY1001 Start Date*: 2019-02-06
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 1/2, First-in-Human, Open-Label, Dose Escalation Study of Talquetamab, a Humanized GPRC5D x CD3 Bispecific Antibody, in Subjects with Relapsed or Refractory Multiple Myeloma
    Medical condition: Relapsed or Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10005330 Blood and lymphatic system disorders congenital HLGT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Trial now transitioned) DE (Trial now transitioned) PL (Trial now transitioned) FR (Trial now transitioned) BE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2019-000330-19 Sponsor Protocol Number: 64407564MMY1002 Start Date*: 2019-09-27
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Phase 1b Study of Subcutaneous Daratumumab Regimens in Combination with Bispecific T Cell Redirection Antibodies for the Treatment of Subjects with Multiple Myeloma
    Medical condition: Multiple myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2021-000296-36 Sponsor Protocol Number: ZWI-ZW25-301 Start Date*: 2021-11-17
    Sponsor Name:Zymeworks Inc.
    Full Title: A Randomized, Multicenter, Phase 3 Study of Zanidatamab in Combination with Chemotherapy with or without Tislelizumab in Subjects with HER2-positive Unresectable Locally Advanced or Metastatic Gast...
    Medical condition: Gastroesophageal Adenocarcinoma (GEA)
    Disease: Version SOC Term Classification Code Term Level
    22.0 100000004864 10082464 Advanced gastric carcinoma LLT
    21.1 100000004864 10055458 Esophageal adenocarcinoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) PT (Trial now transitioned) BE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned) IE (Trial now transitioned) IT (Trial now transitioned) EE (Trial now transitioned) RO (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006495-16 Sponsor Protocol Number: PrEPSo Start Date*: 2022-02-25
    Sponsor Name:ISTITUTO NAZIONALE PER LE MALATTIE INFETTIVE "LAZZARO SPALLANZANI"
    Full Title: Immunogenicity and safety of Sotrovimab (Vir 7831) IV as primary prophylaxis in anti-SARS-CoV-2 vaccine non responders
    Medical condition: Covid 19 Infection
    Disease: Version SOC Term Classification Code Term Level
    23.1 10042613 - Surgical and medical procedures 10084458 COVID-19 prophylaxis PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2019-002179-32 Sponsor Protocol Number: BO41423 Start Date*: 2019-10-15
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, EFFICACY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF EMICIZUMAB IN PATIENTS WITH MILD OR MODERATE HEMOPHILIA A WITHOUT FVIII INHIBITORS
    Medical condition: Mild or moderate hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Children, Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Restarted) DE (Trial now transitioned) NL (Ongoing) PL (Completed) BE (Trial now transitioned) FR (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-002339-44 Sponsor Protocol Number: IGM-2323-001 Start Date*: Information not available in EudraCT
    Sponsor Name:IGM Biosciences, Inc.
    Full Title: A Phase 1/2 Open-Label, Multicenter Study Evaluating the Safety and Pharmacokinetics of Escalating Doses of IGM-2323 in Subjects with Relapsed/Refractory Non-Hodgkin Lymphomas
    Medical condition: Relapsed/Refractory (R/R) Non-Hodgkin lymphomas (NHL)
    Disease: Version SOC Term Classification Code Term Level
    23.0 100000004864 10025311 Lymphoma (non-Hodgkin's) LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) IT (Completed) DK (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003277-42 Sponsor Protocol Number: MCLA-128-CL01 Start Date*: 2015-01-13
    Sponsor Name:Merus B.V.
    Full Title: A Phase I/II Study of MCLA-128, a full length IgG1 Bispecific Antibody Targeting HER2 and HER3, in Patients with Solid Tumors
    Medical condition: Solid Tumors
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004864 10049280 Solid tumour LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) NL (Ongoing) FR (Trial now transitioned) PT (Completed) NO (Trial now transitioned) DE (Trial now transitioned) AT (Trial now transitioned) DK (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2006-002727-16 Sponsor Protocol Number: IP-CAT-GC-03 Start Date*: 2007-03-06
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Multicenter, open-label phase II study to evaluate the safety and efficacy of the tri-functional bispecific antibody catumaxomab (anti-EpCAM x anti-CD3) in patients with gastric adenocarcinoma afte...
    Medical condition: Gastric Neoplasm malignant
    Disease: Version SOC Term Classification Code Term Level
    15.0 10017947 - Gastrointestinal disorders 10017812 Gastric neoplasms malignant HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000072-17 Sponsor Protocol Number: BH30071 Start Date*: 2016-06-30
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF PROPHYLACTIC EMICIZUMAB VERSUS NO PROPHYLAXIS IN HEMOPHILIA A PATIENTS WITH...
    Medical condition: Haemophilia A without factor VIII inhibitors
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IE (Completed) ES (Ongoing) DE (Completed) PL (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-001789-39 Sponsor Protocol Number: LAVA1207-001 Start Date*: 2021-07-13
    Sponsor Name:LAVA Therapeutics N.V.
    Full Title: A Phase 1 and 2a open-label trial to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and antitumor activity of LAVA-1207, a PSMA-targeting bispecific γδ-T cel...
    Medical condition: Prostate Cancer
    Disease: Version SOC Term Classification Code Term Level
    27.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10036909 Prostate cancer metastatic PT
    Population Age: Adults, Elderly Gender: Male
    Trial protocol: NL (Trial now transitioned) ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-004606-60 Sponsor Protocol Number: BP42772 Start Date*: 2021-06-22
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A 3-ARM, RANDOMIZED, BLINDED, ACTIVE-CONTROLLED, PHASE II STUDY OF RO7121661, A PD1-TIM3 BISPECIFIC ANTIBODY AND RO7247669, A PD1-LAG3 BISPECIFIC ANTIBODY, COMPARED WITH NIVOLUMAB IN PARTICIPANTS W...
    Medical condition: Advanced or metastatic squamous cell carcinoma of the esophagus
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10015362 Esophageal cancer LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Trial now transitioned) DK (Trial now transitioned) HU (Trial now transitioned) BE (Completed) FR (Trial now transitioned) IT (Trial now transitioned) CZ (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-000073-21 Sponsor Protocol Number: BH29992 Start Date*: 2016-05-12
    Sponsor Name:Roche Farma, S.A., que representa en España a F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE-ARM, MULTICENTER, OPEN-LABEL, PHASE III CLINICAL TRIAL TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF ONCE WEEKLY SUBCUTANEOUS ADMINISTRATION OF EMICIZUMAB IN HEMOPHILIA A PEDIA...
    Medical condition: Hemophilia A with Inhibitors
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GB (GB - no longer in EU/EEA) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2019-003298-24 Sponsor Protocol Number: R4018ONC1721 Start Date*: 2020-06-11
    Sponsor Name:Regeneron Pharmaceuticals, Inc.
    Full Title: A Phase 1/2 Study of REGN4018 (A MUC16xCD3 Bispecific Antibody) Administered Alone or in Combination with Cemiplimab in Patients with Recurrent Ovarian Cancer or Other Recurrent MUC16+ Cancers
    Medical condition: Recurrent Ovarian Cancer Recurrent Fallopian Tube Cancer Recurrent Primary Peritoneal Cancer Recurrent Endometrial Cancer
    Disease: Version SOC Term Classification Code Term Level
    21.1 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10066697 Ovarian cancer recurrent PT
    21.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10014736 Endometrial cancer recurrent PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: BE (Trial now transitioned) ES (Ongoing) NL (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-005105-12 Sponsor Protocol Number: GR40398 Start Date*: 2018-09-18
    Sponsor Name:F.Hoffmann La-Roche Ltd
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FARICIMAB (RO6867461) IN PATIENTS WITH DIABETIC MACULAR EDEMA (RHINE)
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) HU (Completed) DE (Completed) CZ (Completed) GB (GB - no longer in EU/EEA) DK (Completed) PL (Completed) ES (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2006-005017-36 Sponsor Protocol Number: IV-ERT-BC-03 Start Date*: 2007-01-19
    Sponsor Name:Fresenius Biotech GmbH
    Full Title: Phase II study for repeated dosing of the trifunctional bispecific anti-HER-2/neu x anti-CD3 antibody ertumaxomab in patients with HER-2/neu 1+ or 2+/FISH negative expressing advanced or metastat...
    Medical condition: Hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV), which are known to express HER-2/neu (1+ or 2+) and are FISH negative.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10006201 Breast cancer stage III LLT
    9.1 10006202 Breast cancer stage IV LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Prematurely Ended) ES (Ongoing) DE (Prematurely Ended) FR (Ongoing) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2016-004366-25 Sponsor Protocol Number: MO39129 Start Date*: 2017-10-09
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A SINGLE-ARM, MULTICENTER PHASE IIIB CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF PROPHYLACTIC EMICIZUMAB IN HEMOPHILIA A PATIENTS WITH INHIBITORS
    Medical condition: Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10060612 Hemophilia A LLT
    20.0 100000004850 10053751 Hemophilia A with anti factor VIII LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: PT (Completed) GB (GB - no longer in EU/EEA) DE (Completed) DK (Prematurely Ended) HU (Completed) ES (Completed) PL (Completed) FI (Completed) BE (Completed) SE (Completed) NL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2020-005092-13 Sponsor Protocol Number: MO42623 Start Date*: Information not available in EudraCT
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A MULTICENTER, OPEN-LABEL PHASE IV STUDY TO EVALUATE OVERALL HEALTH, PHYSICAL ACTIVITY, AND JOINT OUTCOMES, IN PARTICIPANTS AGED ≥ 13 AND < 70 YEARS WITH SEVERE OR MODERATE HEMOPHILIA A WITHOUT FVI...
    Medical condition: Severe or Moderate Hemophilia A
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004850 10053753 Hemophilia A without inhibitors LLT
    Population Age: Adolescents, Under 18, Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Prematurely Ended) DE (Trial now transitioned) ES (Ongoing) IT (Trial now transitioned) HU (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-006816-10 Sponsor Protocol Number: CO43476 Start Date*: 2022-10-17
    Sponsor Name:F. Hoffman-La Roche Ltd.
    Full Title: A PHASE I/II, OPEN-LABEL, MULTI-COHORT STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CEVOSTAMAB IN PRIOR B CELL MATURATION ANTIGEN-EXPOSED PATIENTS WITH RELAPSED/REFRACTORY MULTIPLE MYELOMA
    Medical condition: Relapsed/Refractory Multiple Myeloma
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004864 10028228 Multiple myeloma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) DE (Trial now transitioned) BE (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2017-005104-10 Sponsor Protocol Number: GR40349 Start Date*: 2018-11-08
    Sponsor Name:F.Hoffmann La-Roche Ltd
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-MASKED, ACTIVE COMPARATOR-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF RO6867461 IN PATIENTS WITH DIABETIC MACULAR EDEMA (YOSEMITE)
    Medical condition: Diabetic Macular Edema (DME)
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004853 10057934 Diabetic macular edema LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) DE (Completed) HU (Completed) AT (Completed) PL (Completed) ES (Ongoing) IT (Completed)
    Trial results: View results
    EudraCT Number: 2021-003569-36 Sponsor Protocol Number: D9571C00001 Start Date*: 2022-04-01
    Sponsor Name:AstraZeneca AB,
    Full Title: A Phase I/II Open-label, Multi-center Study to Assess Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD7789, an Anti-PD-1 and Anti-TIM-3 Bispecific Antibody, in Patients with R...
    Medical condition: Relapse/Refractory Classical Hodgkin Lymphoma
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004864 10080208 Classical Hodgkin lymphoma LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) IT (Trial now transitioned) ES (Ongoing) DK (Trial now transitioned)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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