2025-523396-38-00RecruitingPhase 1/2
Multi-centre Phase 1/2 study testing LB-208 for adults with relapsed/refractory AML or high-risk MDS
Multicentre, open-label, phase 1/2 study of LB-208, selective antagonist of the serotonin 5-hydroxytryptamine receptor 1B (HTR1B), in adults with relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 9 Oct 2026
Brief summary (registry, in English)
- To evaluate the safety, and tolerability of LB-208 administered continuously as a single agent CCI in participants with r/r AML and r/r HR-MDS. - To determine MTD and/or the recommended Phase 2 dose of LB-208 in participants with r/r AML and r/r HR-MDS.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 22 Dec 2025
- Start date
- 29 May 2026
- Lead sponsor
- Aop Orphan Pharmaceuticals GmbH
- EU CT number
- 2025-523396-38-00
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 60
- 6 sites in 1 country
- 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 acute myeloid leukaemia (AML) or higher-risk myelodysplastic syndrome (MDS) has come back or has not responded to treatment.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- AML or MDS that has come back (relapsed) or did not respond (refractory). For AML: standard treatment has failed, or at least one earlier line of therapy was given, with no available therapy known to help.
- Earlier treatment
- For relapsed AML: at least one earlier line of therapy, such as intensive chemotherapy, hypomethylating agents or targeted therapies, unless such therapy is not safe or tolerable.
Main reasons for not taking part
- Pregnant or breastfeeding
- Active severe infection or unexplained fever above 38.5°C at screening or on the first day of treatment
- Any other medical or psychological condition that could interfere with consent or taking part 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.
Other illness
- Participants with any other medical or psychological condition, deemed by the Investigator to be likely to interfere with a subject’s ability to sign informed consent, cooperate, or participate in the study.
- Patients with an active severe infection or with an unexplained fever >38.5°C during screening visits or on their first day of study drug administration (at the discretion of the Investigator, participant with tumour fever may be enrolled).
Other
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- CCI
- Patients who are pregnant or breast feeding.
- CCI
- CCI
Who the study is looking for
- Written informed consent obtained prior to performing any protocol related procedure.
- CCI
- Female participants with reproductive potential must have a negative serum pregnancy test within 7 days prior to the start of therapy. Participants with reproductive potential are defined as one who is biologically capable of becoming pregnant.
- Women of childbearing potential as well as fertile men and their partners must agree to abstain from sexual intercourse or to use a highly effective form of contraception during the study and for 90 days (males) and 6 months (females) following the last dose of LB-208 (see Appendix 3). In addition, males must not donate sperm during dosing and 3 months after stopping study treatment.
- Participants must be able to understand and willing to sign an informed consent.
- Participants must be male or female ≥18 years of age at the time of signing the informed consent.
- Participants must have an advanced haematologic malignancy either AML or MDS diagnosed according to the World Health Organization (WHO) 2022 classification and relapse or refractory disease according ELN 2022 or IWG2023 as listed below: - Relapsed AML as defined by ELN 2022 and World Health Organization (WHO) criteria in patients with pathologically documented AML that has failed standard treatment, or patients who received at least one prior line of therapy including intensive chemotherapy, hypomethylating agents, or standard therapies including targeted therapies (unless the therapy is contraindicated or intolerable) with no available therapies known to provide clinical benefit in the opinion of the treating investigator. - CCI
- CCI
- CCI
- CCI
- CCI
- CCI
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (6)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Barcelona | Spain | Recruiting |
| Hospital San Pedro De Alcántara | Cáceres | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón | Madrid | Spain | Recruiting |
| Hospital Universitario Central De Asturias | Oviedo | Spain | Recruiting |
| Clínica Universidad de navarra | Pamplona | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe | Valencia | Spain | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.