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
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
- Diseases
- Multiple myeloma
- 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
Sites (33)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Ziekenhuis Gent | Gent | Belgium | Not yet recruiting |
| UZ Leuven | Leuven | Belgium | Not yet recruiting |
| Centre Hospitalier Universitaire de Liège | Liège | Belgium | Not yet recruiting |
| Fakultni nemocnice Brno | Brno | Czechia | Not yet recruiting |
| Fakultni nemocnice Ostrava | Ostrava | Czechia | Not yet recruiting |
| University Medical Center Hamburg-Eppendorf | Hamburg | Germany | Recruiting |
| Universitaetsklinikum Heidelberg AöR | Heidelberg | Germany | Recruiting |
| LMU Klinikum Muenchen AöR | Munich | Germany | Recruiting |
| Universitaetsklinikum Wuerzburg AöR | Wuerzburg | Germany | Recruiting |
| Centre Hospitalier Universitaire De Montpellier | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes | Nantes | France | Not yet recruiting |
| Assistance Publique Hopitaux de Paris | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Poitiers | Poitiers | France | Not yet recruiting |
| Oncopole Claudius Regaud | Toulouse | France | Not yet recruiting |
| General Hospital of Athens - Alexandra | Athens | Greece | Not yet recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" | Chaïdári | Greece | Not yet recruiting |
| University General Hospital of Thessaloniki - AHEPA | Thessaloniki | Greece | Not yet recruiting |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII | Bergamo | Italy | Not yet recruiting |
| Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.l | Meldola | Italy | Not yet recruiting |
| Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico | Milan | Italy | Not yet recruiting |
| IRCCS Istituto Nazionale Tumori Fondazione Pascale | Naples | Italy | Not yet recruiting |
| Azienda Unità Sanitaria Locale della Romagna | Ravenna | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino | Turin | Italy | Not yet recruiting |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny Nr 1 w Lublinie | Lublin | Poland | Recruiting |
| Uniwersytecki Szpital Kliniczny w Poznaniu | Poznan | Poland | Recruiting |
| Narodowy Instytut Onkologii im Marii Sklodowskiej Curie Panstwowy Instytut Badawczy | Warsaw | Poland | Recruiting |
| CCAB Centro Clinico Academico Braga Associacao | Braga | Portugal | Recruiting |
| Instituto Portugues de Oncologia de Lisboa Francisco Gentil, E.P.E. | Lisbon | Portugal | Recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. | Porto | Portugal | Recruiting |
| Soedra Aelvsborg Hospital Vaestra Goetalandsregionen | Boras | Sweden | Not yet recruiting |
| Sahlgrenska University Hospital-Vaestra Goetalandsregionen | Goteborg | Sweden | Not yet recruiting |
| Karolinska University Hospital | Huddinge | Sweden | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.