Clinical trial • Phase I/II • Oncology
AZD0305 for Multiple myeloma
Phase I/II trial of AZD0305 for Multiple myeloma. open-label, none/not specified-controlled, adaptive. 224 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- ADC | Bispecific antibody | Small molecule
Key dates
- Initial CTIS Submission Date
- 06-02-2024
- First CTIS Authorization Date
- 14-05-2024
Trial design
open-label, none/not specified-controlled, adaptive Phase I/II trial in Spain, France, Germany.
- Open Label
- Yes
- Comparator
- None/Not specified
- Adaptive
- True, dose escalation design with determination of Recommended Phase 2 Dose (RP2D) (Phase Ia dose escalation and Phase Ib expansion/optimization modules).
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 224
Eligibility
Recruits 224 adults.
Inclusion criteria
- {"criterion_text":"- Participants must be at least 18 years of age or the legal age of consent in the jurisdiction in which the study is taking place.\n- Eastern Cooperative Oncology Group performance status of ≤ 2 in module 1, or 0 or 1 in modules 2 and 3\n- Documentation of Multiple Myeloma (MM) as defined by International Myeloma Working Group (IMWG) Diagnostic Criteria for Multiple Myeloma. Site should ensure that Multiple Myeloma diagnosis is confirmed in accordance with the IMWG Diagnostic Criteria\n- Participants must have one or more measurable disease criteria for Serum M-Protein, Urine M-protein, and Serum immunoglobulin free light chains as specified in the relevant module of the CSP;\n- Adequate organ and bone marrow function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP as relevant to each module\n- Participants must have received at least 3 prior lines of treatment in module 1. In modules 2 and 3, participants must meet the phase-specific requirements for the number of prior lines of therapy.\n- The above is a summary of key criteria, other inclusion criteria details may apply"}
Exclusion criteria
- {"criterion_text":"- Amyloidosis, plasma cell leukemia, Waldenstrom Macroglobulinemia, Polyneuropathy Organomegaly Endocrinopathy M-protein and Skin Syndrome, or Smoldering Multiple Myeloma (compliant with WHO criteria);\n- Participants who have previously received anti-GPRC5D or MMAE-containing treatment.\n- Participants with a history of prior malignancy other than MM within 3 years prior to first dose of study intervention. some exceptions apply\n- Participants with previous history of active John Cunningham virus infection resulting in PML\n- Participants with a known hypersensitivity to AZD0305 or any of the excipients of the product or to any of the drugs included in the respective modules or who experienced Grade 3 or higher hypersensitivity to prior monocloncal antibody therapy\n- Participants who have uncontrolled severe illness including but not limited to ongoing active infection requiring therapeutic antibiotics and/or other administration\n- The above is a summary of key criteria, other exclusion criteria details may apply\n- Participants who have previously received allogenic stem cell transplant, or participant has received autologous stem cell transplant within 3 months before the first dose of study intervention.\n- Participants exhibiting clinical signs of central nervous system involvement of MM;\n- Participants with known COPD, or previous history of ILD/pneumonitis\n- Participants with known moderate or severe persistent asthma within the past 5 years, or uncontrolled asthma of any classification;\n- Participants who have severe cardiovascular disease which is not adequately controlled.\n- Participants who have a history of immunodeficiency disease.\n- Participants with peripheral neuropathy ≥ Grade 2.\n- Primary refractory MM."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Occurrence of dose-limiting toxicities (Phase Ia dose escalation only).","definition_or_measurement_approach":"Occurrence of dose-limiting toxicities during Phase Ia dose escalation (no further definition provided in the available record)."}
- {"endpoint_text":"- Incidence and severity of AEs and SAEs.","definition_or_measurement_approach":"Assessment of incidence and severity of adverse events (AEs) and serious adverse events (SAEs)."}
- {"endpoint_text":"- these are the core primary endpoints of the study, module specific endpoints are available within the CSP","definition_or_measurement_approach":"Module-specific primary endpoints are available in the Clinical Study Plan (CSP); no further definition provided in the available record."}
Secondary endpoints
- {"endpoint_text":"- Preliminary efficacy of AZD0305 according to IMWG 2016 response criteria as assessed by investigator, including response endpoints ORR, CRR (module 2 only), DoR, MRD negative CR rate (Modules 2 and 3 only), PFS, and OS.","definition_or_measurement_approach":"Efficacy assessed per IMWG 2016 response criteria by investigator, including ORR, CRR (module 2), DoR, MRD negative CR rate (modules 2 and 3), progression-free survival (PFS), overall survival (OS)."}
- {"endpoint_text":"- PK parameters of AZD0305 (total ADC), total antibody (conjugated and unconjugated) and MMAE, including but not limited to AUC, Cmax, tmax, clearance, and half-life, as data allow.","definition_or_measurement_approach":"Measurement of PK parameters for AZD0305 (total ADC), total antibody and MMAE including AUC, Cmax, tmax, clearance, and half-life."}
- {"endpoint_text":"- The number and percentage of participants who develop Anti-Drug Antibody (ADA).","definition_or_measurement_approach":"Count and percentage of participants developing anti-drug antibodies (ADA)."}
- {"endpoint_text":"- These are the core secondary endpoints of the study, module specific endpoints are available within the CSP","definition_or_measurement_approach":"Module-specific secondary endpoints are available in the Clinical Study Plan (CSP); no further definition provided in the available record."}
Recruitment
- Planned Sample Size
- 224
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent is provided by adult participants (participants must be at least 18 years of age). Subject information and informed consent forms (SIS and ICF) are available, including module-specific ICFs and documents for adult genomics and pregnant partners (separate ICF materials listed), indicating separate consent materials for genetic optional consent and pregnant partners.
Geography
- Total Number Of Sites
- 14
- Total Number Of Participants
- 68
Spain
- Earliest CTIS Part Ii Submission Date
- 27-03-2024
- Latest Decision Or Authorization Date
- 13-05-2026
- Processing Time Days
- 777
- Number Of Sites
- 5
- Number Of Participants
- 18
Sites
- Site Name
- Hospital Germans Trias I Pujol
- Department Name
- Oncology
- Principal Investigator Name
- Albert Oriol Rocafiguera
- Principal Investigator Email
- aoriol@icooncologia.net
- Contact Person Name
- Albert Oriol Rocafiguera
- Contact Person Email
- aoriol@icooncologia.net
- Site Name
- Clinica Universidad De Navarra
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez
- Contact Person Email
- paurodriguez@unav.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Hematology
- Principal Investigator Name
- Maria Victoria Mateos
- Principal Investigator Email
- mvmateos@usal.es
- Contact Person Name
- Maria Victoria Mateos
- Contact Person Email
- mvmateos@usal.es
- Site Name
- Hospital Universitario 12 De Octubre
- Department Name
- Hematology
- Principal Investigator Name
- Joaquin Martinez
- Principal Investigator Email
- jmarti01@med.ucm.es
- Contact Person Name
- Joaquin Martinez
- Contact Person Email
- jmarti01@med.ucm.es
- Site Name
- Clinica Universidad De Navarra (Pamplona)
- Department Name
- Hematology
- Principal Investigator Name
- Paula Rodriguez
- Principal Investigator Email
- paurodriguez@unav.es
- Contact Person Name
- Paula Rodriguez
- Contact Person Email
- paurodriguez@unav.es
France
- Earliest CTIS Part Ii Submission Date
- 12-08-2024
- Latest Decision Or Authorization Date
- 12-05-2026
- Processing Time Days
- 638
- Number Of Sites
- 2
- Number Of Participants
- 20
Sites
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service d'hématologie clinique
- Principal Investigator Name
- Cyrille Touzeau
- Principal Investigator Email
- Cyrille.TOUZEAU@chu-nantes.fr
- Contact Person Name
- Cyrille Touzeau
- Contact Person Email
- Cyrille.TOUZEAU@chu-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service d’Hématologie
- Principal Investigator Name
- Salomon Manier
- Principal Investigator Email
- salomon.manier@chu-lille.fr
- Contact Person Name
- Salomon Manier
- Contact Person Email
- salomon.manier@chu-lille.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 08-04-2024
- Latest Decision Or Authorization Date
- 11-05-2026
- Processing Time Days
- 763
- Number Of Sites
- 7
- Number Of Participants
- 30
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- Klinik für Haematologie und Stammzelltransplantation
- Principal Investigator Name
- Amelie Boquoi
- Principal Investigator Email
- amelie.boquoi@uk-essen.de
- Contact Person Name
- Amelie Boquoi
- Contact Person Email
- amelie.boquoi@uk-essen.de
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Myeolomzentrum Klinik für hämatologie, Onkologie, Rheumatologie
- Principal Investigator Name
- Marc-Steffen Raab
- Principal Investigator Email
- marc.raab@med.uni-heidelberg.de
- Contact Person Name
- Marc-Steffen Raab
- Contact Person Email
- marc.raab@med.uni-heidelberg.de
- Site Name
- Universitaetsklinikum Wuerzburg AöR
- Department Name
- Poliklinik MED II Haematologie Onkologie
- Principal Investigator Name
- Leo Rasche
- Principal Investigator Email
- rasche_l@ukw.de
- Contact Person Name
- Leo Rasche
- Contact Person Email
- rasche_l@ukw.de
- Site Name
- Klinikum Nuernberg
- Department Name
- Klinik fuer Innere Medizin 5
- Principal Investigator Name
- Stefan Knop
- Principal Investigator Email
- stefan.knop@klinikum-nuernberg.de
- Contact Person Name
- Stefan Knop
- Contact Person Email
- stefan.knop@klinikum-nuernberg.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- Zentrum für Onkologie 2. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Katja Weisel
- Principal Investigator Email
- k.weisel@uke.de
- Contact Person Name
- Katja Weisel
- Contact Person Email
- k.weisel@uke.de
- Site Name
- Eberhard Karls Universitaet Tuebingen
- Department Name
- Klinik für Hämatologie und Stammzelltransplantation
- Principal Investigator Name
- Britta Besemer
- Principal Investigator Email
- Britta.Besemer@med.uni-tuebingen.de
- Contact Person Name
- Britta Besemer
- Contact Person Email
- Britta.Besemer@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Schleswig-Holstein AöR
- Department Name
- Klinik für Haematologie und Onkologie
- Principal Investigator Name
- Cyrus Khandanpour
- Principal Investigator Email
- Cyrus.Khandanpour@uksh.de
- Contact Person Name
- Cyrus Khandanpour
- Contact Person Email
- Cyrus.Khandanpour@uksh.de
Sponsor
Primary sponsor
- Full Name
- AstraZeneca AB
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Sweden
Investigational products
- Investigational Product Name
- AZD0305
- Active Substance
- AZD0305
- Modality
- ADC
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Investigational Product Name
- ELRANATAMAB
- Active Substance
- ELRANATAMAB
- Modality
- Bispecific antibody
- Routes Of Administration
- SUBCUTANEOUS INJECTION
- Route
- SUBCUTANEOUS INJECTION
- Investigational Product Name
- POMALIDOMIDE
- Active Substance
- DIMETHYL FUMARATE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Combination Treatment
- Yes
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