Clinical trial • Phase I/II • Oncology
SURZETOCLAX for Multiple myeloma
Phase I/II trial of SURZETOCLAX for Multiple myeloma.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Multiple myeloma
- Trial Stage
- Phase I/II
- Drug Modality
- Small molecule|Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 12-06-2025
- First CTIS Authorization Date
- 06-10-2025
Trial design
open-label, antimyeloma agents (dexamethasone, pomalidomide, daratumumab) - doses and schedules not specified-controlled, adaptive Phase I/II trial across 27 sites in Belgium, Germany, Italy and others.
- Open Label
- Yes
- Comparator
- Antimyeloma agents (dexamethasone, pomalidomide, daratumumab) - doses and schedules not specified
- Adaptive
- True, includes dose-escalation based on DLT assessment to determine tolerability and appropriate dosing; specific escalation rules not provided in available data.
- Single Multiple Or Escalation Dose Combined
- Yes
- Target Sample Size
- 43
Eligibility
Recruits 43 No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent documents provided (multiple ICFs: main, prescreening, optional, pregnancy parts) in country-specific languages as listed in the study documents..
- Vulnerable Population
- No vulnerable populations selected (isVulnerablePopulationSelected: false). Informed consent documents provided (multiple ICFs: main, prescreening, optional, pregnancy parts) in country-specific languages as listed in the study documents.
Inclusion criteria
- {"criterion_text":"- Documented diagnosis of multiple myeloma (MM) based on standard international myeloma working group (IMWG) diagnostic criteria.\n- All participants must have measurable disease per central laboratory with at least 1 of the following assessed within 28 days prior to enrollment: -- Serum M-protein >= 0.5 g/dL (>= 5g/L); OR -- Urine M-protein >= 200 mg/24 hours; OR -- For participants without measurable serum and urine M-protein: Serum free light chain (sFLC) ≥ 10 mg/dL (100 mg/L), provided sFLC ratio is abnormal.\n- B-cell lymphoma (BCL)-2 inhibitor treatment naïve."}
Exclusion criteria
- {"criterion_text":"- Major surgery within 4 weeks of study treatment or planned during study participation.\n- Recent infection requiring systemic treatment that was completed <= 7 days before first dose of study treatment and/or uncontrolled active systemic infection."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Dose Limiting Toxicities (DLT)s of ABBV-453","definition_or_measurement_approach":""}
- {"endpoint_text":"- Safety and tolerability (AEs and SAEs, clinical laboratory parameters, vital sign measurements, and ECG results).","definition_or_measurement_approach":"Assessment of adverse events (AEs) and serious adverse events (SAEs), clinical laboratory parameters, vital sign measurements, and ECG results as measures of safety and tolerability."}
Secondary endpoints
- {"endpoint_text":"- Overall Response Rate (ORR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Progression-Free Survival (PFS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Duration of Response (DOR)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time-to-Progression (TTP)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Time to Next Treatment","definition_or_measurement_approach":""}
- {"endpoint_text":"- Rate and Depth of minimal residual disease (MRD) Negativity Determined Centrally","definition_or_measurement_approach":"MRD negativity determined by central laboratory assessment."}
- {"endpoint_text":"- Overall survival (OS)","definition_or_measurement_approach":""}
- {"endpoint_text":"- Pharmacokinetics (PK): Cmax, Tmax, t ½ , AUC.","definition_or_measurement_approach":"PK parameters to be measured: Cmax, Tmax, half-life (t½), and AUC."}
Recruitment
- Planned Sample Size
- 43
- Recruitment Window Months
- 41
- Consent Approach
- Informed consent obtained from adult participants using country-specific ICFs (main, prescreening, optional, pregnancy sections). ICF documents are available in multiple languages (examples from document list include English, French, Dutch, German, Italian, Portuguese, Swedish, Polish).
Geography
- Total Number Of Sites
- 27
- Total Number Of Participants
- 76
Belgium
- Earliest CTIS Part Ii Submission Date
- 08-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 28
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Centre hospitalier universitaire de Liege
- Department Name
- Hematology
- Principal Investigator Name
- Bernard De Prijck
- Principal Investigator Email
- bernard.deprijck@chuliege.be
- Contact Person Name
- Bernard De Prijck
- Contact Person Email
- bernard.deprijck@chuliege.be
- Site Name
- UZ Leuven
- Department Name
- Hematology
- Principal Investigator Name
- Michel Delforge
- Principal Investigator Email
- michel.delforge@uzleuven.be
- Contact Person Name
- Michel Delforge
- Contact Person Email
- michel.delforge@uzleuven.be
- Site Name
- Universitair Ziekenhuis Gent
- Department Name
- Hematology
- Principal Investigator Name
- Nicolas Kint
- Principal Investigator Email
- nicolas.kint@uzgent.be
- Contact Person Name
- Nicolas Kint
- Contact Person Email
- nicolas.kint@uzgent.be
Germany
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 08-10-2025
- Processing Time Days
- 20
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Universitaetsklinikum Heidelberg AöR
- Department Name
- Medizinische Klinik V
- 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
- Medizinische Klinik und Poliklinik II
- Principal Investigator Name
- Martin Kortuem
- Principal Investigator Email
- Kortuem_M@ukw.de
- Contact Person Name
- Martin Kortuem
- Contact Person Email
- Kortuem_M@ukw.de
- Site Name
- LMU Klinikum Muenchen AöR
- Department Name
- Medizinische Klinik und Poliklinik III
- Principal Investigator Name
- Sebastian Theurich
- Principal Investigator Email
- sebastian.theurich@med.uni-muenchen.de
- Contact Person Name
- Sebastian Theurich
- Contact Person Email
- sebastian.theurich@med.uni-muenchen.de
- Site Name
- University Medical Center Hamburg-Eppendorf
- Department Name
- II. Medizinische Klinik und Poliklinik
- Principal Investigator Name
- Katja Weisel
- Principal Investigator Email
- myelomstudien@uke.de
- Contact Person Name
- Katja Weisel
- Contact Person Email
- myelomstudien@uke.de
Italy
- Earliest CTIS Part Ii Submission Date
- 18-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 18
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- IRCCS Istituto Nazionale Tumori Fondazione Pascale
- Department Name
- SC Ematologia Oncologica e Trapianto di Cellule Staminali
- Principal Investigator Name
- Antonio Pinto
- Principal Investigator Email
- a.pinto@istitutotumori.na.it
- Contact Person Name
- Antonio Pinto
- Contact Person Email
- a.pinto@istitutotumori.na.it
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
- Department Name
- Hematology and Bone Marrow Unit
- Principal Investigator Name
- Monica Galli
- Principal Investigator Email
- monicagalli@asst-pg23.it
- Contact Person Name
- Monica Galli
- Contact Person Email
- monicagalli@asst-pg23.it
- Site Name
- Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
- Department Name
- S.C. Ematologia
- Principal Investigator Name
- Matteo Claudio Da Via
- Principal Investigator Email
- matteo.davia@policlinico.mi.it
- Contact Person Name
- Matteo Claudio Da Via
- Contact Person Email
- matteo.davia@policlinico.mi.it
- Site Name
- Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
- Department Name
- Hematology U Division
- Principal Investigator Name
- Francesca Gay
- Principal Investigator Email
- francesca.gay@unito.it
- Contact Person Name
- Francesca Gay
- Contact Person Email
- francesca.gay@unito.it
- Site Name
- Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
- Department Name
- HEMATOLOGY UNIT
- Principal Investigator Name
- Claudio Cerchione
- Principal Investigator Email
- claudio.cerchione@irst.emr.it
- Contact Person Name
- Claudio Cerchione
- Contact Person Email
- claudio.cerchione@irst.emr.it
Portugal
- Earliest CTIS Part Ii Submission Date
- 12-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 24
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Paulo Bernardo
- Principal Investigator Email
- pbernardo@ipolisboa.min-saude.pt
- Contact Person Name
- Paulo Bernardo
- Contact Person Email
- pbernardo@ipolisboa.min-saude.pt
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Oncology
- Principal Investigator Name
- Jose Freitas
- Principal Investigator Email
- jose.p.freitas@hb.min-saude.pt
- Contact Person Name
- Jose Freitas
- Contact Person Email
- jose.p.freitas@hb.min-saude.pt
- Site Name
- Instituto Portugues De Oncologia Do Porto Francisco Gentil E.P.E.
- Department Name
- Oncology
- Principal Investigator Name
- Claudia Moreira
- Principal Investigator Email
- csmoreira@ipoporto.min-saude.pt
- Contact Person Name
- Claudia Moreira
- Contact Person Email
- csmoreira@ipoporto.min-saude.pt
Sweden
- Earliest CTIS Part Ii Submission Date
- 10-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 26
- Number Of Sites
- 3
- Number Of Participants
- 7
Sites
- Site Name
- Soedra Aelvsborg Hospital Vaestra Goetalandsregionen
- Department Name
- Medicinkliniken, Hiss E plan 7
- Principal Investigator Name
- Ulf-Henrik Mellqvist
- Principal Investigator Email
- ulf-henrik.mellqvist@vgregion.se
- Contact Person Name
- Ulf-Henrik Mellqvist
- Contact Person Email
- ulf-henrik.mellqvist@vgregion.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Hematology
- Principal Investigator Name
- Markus Hansson
- Principal Investigator Email
- markus.hansson.2@gu.se
- Contact Person Name
- Markus Hansson
- Contact Person Email
- markus.hansson.2@gu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Cancerstudieenheten M62
- Principal Investigator Name
- Katarina Uttervall
- Principal Investigator Email
- katarina.uttervall@regionstockholm.se
- Contact Person Name
- Katarina Uttervall
- Contact Person Email
- katarina.uttervall@regionstockholm.se
Poland
- Earliest CTIS Part Ii Submission Date
- 25-09-2025
- Latest Decision Or Authorization Date
- 10-10-2025
- Processing Time Days
- 15
- Number Of Sites
- 4
- Number Of Participants
- 13
Sites
- Site Name
- Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
- Department Name
- Klinika Nowotworow Układu Chlonnego
- Principal Investigator Name
- Joanna Romejko-Jarosinska
- Principal Investigator Email
- joanna.romejko-jarosinska@pib-nio.pl
- Contact Person Name
- Joanna Romejko-Jarosinska
- Contact Person Email
- joanna.romejko-jarosinska@pib-nio.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Poznaniu
- Department Name
- Oddzial Hematologii i Transplantacji Szpiku
- Principal Investigator Name
- Dominik Dytfeld
- Principal Investigator Email
- dytfeld@me.com
- Contact Person Name
- Dominik Dytfeld
- Contact Person Email
- dytfeld@me.com
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Oddzial Wieloprofilowy Zachowawczy
- Principal Investigator Name
- Krzysztof Giannopoulos
- Principal Investigator Email
- krzysztofgiannopoulos@umlub.pl
- Contact Person Name
- Krzysztof Giannopoulos
- Contact Person Email
- krzysztofgiannopoulos@umlub.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
- Department Name
- Klinika Hematoonkologii i Transplantacji Szpiku Oddział Hematoonkologii i Transplantacji Szpiku i Ch
- Principal Investigator Name
- Marek Hus
- Principal Investigator Email
- hematoonkologia@usk1.lublin.pl
- Contact Person Name
- Marek Hus
- Contact Person Email
- hematoonkologia@usk1.lublin.pl
France
- Earliest CTIS Part Ii Submission Date
- 22-09-2025
- Latest Decision Or Authorization Date
- 08-12-2025
- Processing Time Days
- 77
- Number Of Sites
- 5
- Number Of Participants
- 12
Sites
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Clinical Hematology
- Principal Investigator Name
- Laure VINCENT
- Principal Investigator Email
- l-vincent@chu-montpellier.fr
- Contact Person Name
- Laure VINCENT
- Contact Person Email
- l-vincent@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Adult Hematology Department
- Principal Investigator Name
- Laurent FRENZEL
- Principal Investigator Email
- laurent.frenzel@aphp.fr
- Contact Person Name
- Laurent FRENZEL
- Contact Person Email
- laurent.frenzel@aphp.fr
- Site Name
- Oncopole Claudius Regaud
- Department Name
- Medical Oncology - Early Phase Unit
- Principal Investigator Name
- Pierre BORIES
- Principal Investigator Email
- bories.pierre@iuct-oncopole.fr
- Contact Person Name
- Pierre BORIES
- Contact Person Email
- bories.pierre@iuct-oncopole.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Clinical Hematology
- 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 Poitiers
- Department Name
- Oncology Hematology
- Principal Investigator Name
- Xavier LELEU
- Principal Investigator Email
- xavier.leleu@chu-poitiers.fr
- Contact Person Name
- Xavier LELEU
- Contact Person Email
- xavier.leleu@chu-poitiers.fr
Sponsor
Primary sponsor
- Full Name
- AbbVie Deutschland GmbH & Co. KG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Germany
Contract research organisations
- Name
- Iqvia Biotech LLC
- Responsibilities
- sponsorDuties codes: [4]; operational/CRO services (contact els.vannylen@iqvia.com)
- Name
- Clario (formerly ERT)
- Responsibilities
- ECG machine for triplicate ECG which applicable for Substudy 2 Japan only; sponsorDuties code 15
- Name
- Advarra Inc.
- Responsibilities
- Central IRB for US
Third parties
- {"country":"United States","full_name":"Abbott Molecular Inc.","duties_or_roles":"sponsorDuties codes: [4]; contact help@abbottmolecular.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"sponsorDuties codes: [6,7]; contact CDMS_Support@veeva.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services Sàrl","duties_or_roles":"sponsorDuties codes: [4]; contact Guillaume.Couffe@labcorp.com","organisation_type":"Health care"}
- {"country":"United Kingdom","full_name":"Qiagen Manchester Limited","duties_or_roles":"sponsorDuties codes: [4]; contact customercare-us@qiagen.com","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Advarra Inc.","duties_or_roles":"Central IRB for US (sponsorDuties code 15); contact cirbi@advarra.com","organisation_type":"Non-Pharmaceutical company"}
- {"country":"United States","full_name":"Clario (formerly ERT)","duties_or_roles":"sponsorDuties code 15; 'ECG machine for triplicate ECG which applicable for Substudy 2 Japan only'; contact customercare@clario.com","organisation_type":"Industry"}
- {"country":"United States","full_name":"Iqvia Biotech LLC","duties_or_roles":"sponsorDuties codes: [4]; contact els.vannylen@iqvia.com","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Surzetoclax
- Active Substance
- SURZETOCLAX
- Modality
- Small molecule
- Routes Of Administration
- Oral
- Route
- Oral
- Investigational Product Name
- DARATUMUMAB
- Active Substance
- DARATUMUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- Subcutaneous
- Route
- Subcutaneous
- Investigational Product Name
- POMALIDOMIDE
- Active Substance
- POMALIDOMIDE
- Modality
- Small molecule
- Routes Of Administration
- Oral (capsule)
- Route
- Oral
- Investigational Product Name
- DEXAMETHASONE
- Active Substance
- DEXAMETHASONE
- Modality
- Small molecule
- Routes Of Administration
- Oral (tablet)
- Route
- Oral
- Combination Treatment
- Yes
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