Clinical trial • Phase I/II • Oncology|Haematology
AZD5492 for B-cell malignancies|Diffuse large B-cell lymphoma|Follicular lymphoma|Mantle cell lymphoma|Chronic lymphocytic leukemia|Small lymphocytic lymphoma|Relapsed or refractory B-cell malignancies
Phase I/II trial of AZD5492 for B-cell malignancies|Diffuse large B-cell lymphoma|Follicular lymphoma|Mantle cell lymphoma|Chronic lymphocytic leukemia|Sm…
Overview
- Trial Therapeutic Area
- Oncology|Haematology
- Trial Disease
- B-cell malignancies|Diffuse large B-cell lymphoma|Follicular lymphoma|Mantle cell lymphoma|Chronic lymphocytic leukemia|Small lymphocytic lymphoma|Relapsed or refractory B-cell malignancies
- Trial Stage
- Phase I/II
- Drug Modality
- Bispecific antibody
Key dates
- Initial CTIS Submission Date
- 09-07-2024
- First CTIS Authorization Date
- 25-10-2024
Trial design
open-label, adaptive Phase I/II trial in Spain, Denmark, Italy and others.
- Open Label
- Yes
- Adaptive
- True, Module 1 includes a Phase I dose escalation (Part A) to determine safety/tolerability/preliminary efficacy and dose(s)/schedule(s) for Part B; Part B is a dose optimization/expansion to characterize safety, antitumor activity and determine RP2D and may be initiated upon protocol amendment if data from Part A support further evaluation.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 110
Eligibility
Recruits 110 Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent form documents are listed for adult subjects, pregnant partners, newborns and optional genomics research, but detailed consent/assent handling text is not provided in the available data..
- Vulnerable Population
- Vulnerable population selected (isVulnerablePopulationSelected: true). Subject information and informed consent form documents are listed for adult subjects, pregnant partners, newborns and optional genomics research, but detailed consent/assent handling text is not provided in the available data.
Inclusion criteria
- {"criterion_text":"- ≥18 years of age\n- The above is a summary, other inclusion criteria details may apply\n- Histologically documented CD20+ mature B-cell neoplasm\n- Large B-cell lymphoma\n- Follicular lymphoma\n- Mantle cell lymphoma\n- Chronic lymphocytic leukemia\n- Small lymphocytic lymphoma\n- Relapsed, progressive and/or refractory disease following at least 2 prior lines of therapy\n- ECOG performance status of = 2 (Note: in EU countries this inclusion is ECOG performance status of < 2)."}
Exclusion criteria
- {"criterion_text":"- Any neoplasm histology not specified in the IC section\n- Active CNS involvement in lymphoma or CNS pathology.\n- CNS pathology including but not limited to any history of seizure disorder/epilepsy\n- Prior allogeneic HSCT within 180 days, prior autologous HSCR within 90 days, or cell therapy within 90 days of start of therapy.\n- History of Grade ≥ 3 CRS or Grade ≥ 3 ICANS.\n- Active and uncontrolled infections.\n- Unresolved AEs ≥2 Grade, from prior therapies.\n- The above is a summary, other exclusion criteria details may apply."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of Dose-Limiting Toxicities (DLTs)\n- Incidence and severity of AEs, AESIs, and SAEs\n- SAEs/AEs leading to discontinuation of AZD5492\n- Clinically significant alterations in vital signs and abnormal laboratory parameters","definition_or_measurement_approach":""}
Secondary endpoints
- {"endpoint_text":"- Evaluate the preliminary antitumor activity of AZD5492 in participants with R/R B-cell malignancies, by looking at: - ORR (Overall Response Rate), CR Rate, DoR (duration of response), and PFS (progression free survival) according to Lugano criteria and iwCLL 2018 criteria; - OS (overall survival).","definition_or_measurement_approach":"Assess antitumor activity using ORR, CR rate, DoR, PFS according to Lugano criteria and iwCLL 2018 criteria; OS (overall survival)."}
- {"endpoint_text":"- Characterize pharmacokinetics profile of AZD5492, by: - Determining PK parameters, including but not limited to Cmax (maximum observed concentration), AUC (Area under the curve), clearance and t½ (half-life). - Antibody serum concentration.","definition_or_measurement_approach":"Determine PK parameters including Cmax, AUC, clearance, t½ and measure antibody serum concentrations."}
- {"endpoint_text":"- Determine the immunogenicity of AZD5492: the number and percentage of participants who develop ADA (Anti Drug Antibodies).","definition_or_measurement_approach":"Report number and percentage of participants who develop anti-drug antibodies (ADA)."}
Recruitment
- Planned Sample Size
- 110
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent is obtained from adult participants. Subject information and informed consent form (SIS and ICF) documents are provided for adult subjects, pregnant partners, newborns, and optional genomics research; multiple ICF/synopsis documents and language-specific protocol synopses are present (titles indicate translations/lay language in Spanish, French, Italian, German). No detailed text about assent for minors or age-specific consent processes is provided in the available data.
Geography
- Total Number Of Sites
- 12
- Total Number Of Participants
- 66
Spain
- Earliest CTIS Part Ii Submission Date
- 01-10-2024
- Latest Decision Or Authorization Date
- 22-12-2025
- Processing Time Days
- 447
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hematology
- Principal Investigator Name
- Raúl Córdoba Mascuñano
- Principal Investigator Email
- raul.cordoba@fjd.es
- Contact Person Name
- Raúl Córdoba Mascuñano
- Contact Person Email
- raul.cordoba@fjd.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Hematology
- Principal Investigator Name
- Pau Abrisqueta Costa
- Principal Investigator Email
- pabrisqueta@vhio.net
- Contact Person Name
- Pau Abrisqueta Costa
- Contact Person Email
- pabrisqueta@vhio.net
- Site Name
- Institut Catala D'oncologia
- Department Name
- Hematology
- Principal Investigator Name
- Ana María Sureda Balari
- Principal Investigator Email
- asureda@iconcologia.net
- Contact Person Name
- Ana María Sureda Balari
- Contact Person Email
- asureda@iconcologia.net
Denmark
- Earliest CTIS Part Ii Submission Date
- 11-10-2024
- Latest Decision Or Authorization Date
- 18-12-2025
- Processing Time Days
- 433
- Number Of Sites
- 1
- Number Of Participants
- 10
Sites
- Site Name
- Rigshospitalet
- Department Name
- Department of Hematology
- Principal Investigator Name
- Martin Hutchings
- Principal Investigator Email
- martin.hutchings@regionh.dk
- Contact Person Name
- Martin Hutchings
- Contact Person Email
- martin.hutchings@regionh.dk
Italy
- Earliest CTIS Part Ii Submission Date
- 25-09-2024
- Latest Decision Or Authorization Date
- 19-01-2026
- Processing Time Days
- 481
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Oncologia Medica
- Principal Investigator Name
- Paolo Prospero Ghia
- Principal Investigator Email
- ghia.paolo@hsr.it
- Contact Person Name
- Paolo Prospero Ghia
- Contact Person Email
- ghia.paolo@hsr.it
- Site Name
- Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
- Department Name
- Malattie oncologiche ed ematologiche
- Principal Investigator Name
- Pier Luigi Zinzani
- Principal Investigator Email
- pierluigi.zinzani@unibo.it
- Contact Person Name
- Pier Luigi Zinzani
- Contact Person Email
- pierluigi.zinzani@unibo.it
France
- Earliest CTIS Part Ii Submission Date
- 14-10-2024
- Latest Decision Or Authorization Date
- 23-12-2025
- Processing Time Days
- 435
- Number Of Sites
- 2
- Number Of Participants
- 12
Sites
- Site Name
- Institut Gustave Roussy
- Department Name
- Hematology
- Principal Investigator Name
- Vincent Ribrag
- Principal Investigator Email
- vincent.ribrag@gustaveroussy.fr
- Contact Person Name
- Vincent Ribrag
- Contact Person Email
- vincent.ribrag@gustaveroussy.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Clinical hematology and cell therapy
- Principal Investigator Name
- François-Xavier Gros
- Principal Investigator Email
- francois-xavier.gros@chu-bordeaux.fr
- Contact Person Name
- François-Xavier Gros
- Contact Person Email
- francois-xavier.gros@chu-bordeaux.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 18-10-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 572
- Number Of Sites
- 4
- Number Of Participants
- 12
Sites
- Site Name
- Universitaetsmedizin Goettingen
- Department Name
- Klinik für Haematologie und Medizinische Onkologie
- Principal Investigator Name
- Johannes Jung
- Principal Investigator Email
- johannes.jung@med.uni-goettingen.de
- Contact Person Name
- Johannes Jung
- Contact Person Email
- johannes.jung@med.uni-goettingen.de
- Site Name
- Klinikum rechts der Isar der TU Muenchen AöR
- Department Name
- Klinik und Poliklinik für Innere Medizin III
- Principal Investigator Name
- Maike Hefter
- Principal Investigator Email
- maike.hefter@mri.tum.de
- Contact Person Name
- Maike Hefter
- Contact Person Email
- maike.hefter@mri.tum.de
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Comprehensive Cancer Center Ulm – Early Clinical Trials Unit
- Principal Investigator Name
- Andreas Viardot
- Principal Investigator Email
- andreas.viardot@uniklinik-ulm.de
- Contact Person Name
- Andreas Viardot
- Contact Person Email
- andreas.viardot@uniklinik-ulm.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- "Medizinische Klinik und Poliklinik II, Zentrum für Innere Medizin"
- Principal Investigator Name
- Max Topp
- Principal Investigator Email
- topp_m@ukw.de
- Contact Person Name
- Max Topp
- Contact Person Email
- topp_m@ukw.de
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD5492
- Active Substance
- AZD5492
- Modality
- Bispecific antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Combination Treatment
- Yes
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