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2025-525105-20-00RecruitingPhase 1/2

A Study to Assess Adverse Events and Change in Disease Activity of Oral Surzetoclax (ABBV-453) Alone or in Combination With Subcutaneous and/or Oral Antimyeloma Agents in Adult Participants With Multiple Myeloma (MM)

A Phase 1/2, Open-Label, Platform Study to Evaluate Safety and Efficacy of the BCL-2 Inhibitor Surzetoclax (ABBV-453) given as Monotherapy or in Combination with Antimyeloma Regimens in Subjects with Multiple Myeloma

Source: EU CTIS (euclinicaltrials.eu) · Last updated 15 Jul 2026

Next steps

Brief summary (registry, in English)

• To characterize the safety, toxicity, and tolerability of surzetoclax in combination with etentamig in biomarker-selected subjects with relapsed or refractory (R/R) Multiple Myeloma (MM) • To determine the recommended doses of surzetoclax and etentamig when given in combination in biomarker-selected subjects with R/R MM

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
88 (estimated)
First submitted
24 Mar 2026
Start date
20 Aug 2026
Lead sponsor
AbbVie Deutschland GmbH & Co. KG
EU CT number
2025-525105-20-00

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 88
  • 33 sites in 9 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

AI-kivonat: who the study is looking for

Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults whose multiple myeloma came back or did not respond to earlier treatment, and who have a certain marker in their cancer cells.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Multiple myeloma that came back or did not respond to treatment (relapsed or refractory), with signs of progression during or after the last treatment.
Earlier treatment
Cannot have had etentamig or any BCMA bispecific treatment before. A stem cell transplant must not be recent (see exclusions).
Biomarker or test result
Centrally tested t(11;14) positive and/or BCL2high status.

Main reasons for not taking part

  • Earlier treatment with etentamig or any BCMA bispecific
  • Autologous stem cell transplant within 12 weeks
  • Allogeneic stem cell transplant within 6 months, or graft versus host disease symptoms after one
  • Serious kidney, nerve, mental health, hormone, metabolic, immune, lung or liver disease in the last 6 months that the investigator thinks would harm the person in the study

Read by machine on 9 Nov 2026.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant who has received prior etentamig treatment or prior treatment with any BCMA bispecific.
  • Participant who has received an autologous stem cell transplant within 12 weeks, or an allogeneic SCT within ≤ 6 months of the first dose of study treatment. Participant who received an allogenic SCT should not have any symptoms of acute or chronic graft versus host disease.

Other illness

  • Participant who has history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, pulmonary, or hepatic disease within the last 6 months that, in investigator's opinion, would adversely affect the participant in the study

Who the study is looking for

  • Participants must have confirmed diagnosis of R/R MM with documented evidence of progression during or after the subject's last treatment regimen based on the investigator's determination of the IMWG 2016 criteria.
  • ECOG performance status 0 or 1.
  • Centrally determined t(11;14) positive status and/or centrally determined BCL2high status.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (33)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universitair Ziekenhuis GentGentBelgiumNot yet recruiting
UZ LeuvenLeuvenBelgiumNot yet recruiting
Centre Hospitalier Universitaire de LiègeLiègeBelgiumNot yet recruiting
Fakultni nemocnice BrnoBrnoCzechiaNot yet recruiting
Fakultni nemocnice OstravaOstravaCzechiaNot yet recruiting
University Medical Center Hamburg-EppendorfHamburgGermanyRecruiting
Universitaetsklinikum Heidelberg AöRHeidelbergGermanyRecruiting
LMU Klinikum Muenchen AöRMunichGermanyRecruiting
Universitaetsklinikum Wuerzburg AöRWuerzburgGermanyRecruiting
Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de NantesNantesFranceNot yet recruiting
Assistance Publique Hopitaux de ParisParisFranceNot yet recruiting
Centre Hospitalier Universitaire de PoitiersPoitiersFranceNot yet recruiting
Oncopole Claudius RegaudToulouseFranceNot yet recruiting
General Hospital of Athens - AlexandraAthensGreeceNot yet recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"ChaïdáriGreeceNot yet recruiting
University General Hospital of Thessaloniki - AHEPAThessalonikiGreeceNot yet recruiting
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamoItalyNot yet recruiting
Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldolaItalyNot yet recruiting
Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilanItalyNot yet recruiting
IRCCS Istituto Nazionale Tumori Fondazione PascaleNaplesItalyNot yet recruiting
Azienda Unità Sanitaria Locale della RomagnaRavennaItalyNot yet recruiting
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di TorinoTurinItalyNot yet recruiting
Uniwersytecki Szpital Kliniczny nr 4 w LublinieLublinPolandRecruiting
Uniwersytecki Szpital Kliniczny Nr 1 w LublinieLublinPolandRecruiting
Uniwersytecki Szpital Kliniczny w PoznaniuPoznanPolandRecruiting
Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut BadawczyWarsawPolandRecruiting
CCAB Centro Clinico Academico Braga AssociacaoBragaPortugalRecruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E.LisbonPortugalRecruiting
Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E.PortoPortugalRecruiting
Soedra Aelvsborg Hospital Vaestra GoetalandsregionenBorasSwedenNot yet recruiting
Sahlgrenska University Hospital-Vaestra GoetalandsregionenGoteborgSwedenNot yet recruiting
Karolinska University HospitalHuddingeSwedenNot yet recruiting

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This page is information, not medical advice. Discuss any trial with your doctor.