Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

RecruitingRare disease

Study of RVU120 treatment in patients with myelodysplastic syndrome, solid tumors, or acute myeloid leukemia who benefited from previous RVU120 therapy

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial studies the continued use of RVU120 (also known as SEL120) in patients with several types of cancer including Acute Myeloid Leukemia, High-Risk Myelodysplastic Syndrome, and advanced or spreading solid tumors that have either come back or did not respond to previous treatments. The purpose of this study is to provide ongoing access to RVU120 treatment for patients who have already been taking this medication in previous studies and are experiencing benefits from it.

The medication being studied, RVU120, comes in the form of capsules that are taken by mouth. The treatment can be given either alone or combined with other medications, depending on how the patient was treated in their previous study. The maximum daily amount that can be given is 150 milligrams, and treatment may continue for up to 5 months.

During the study, doctors will monitor how well patients tolerate the medication by checking for any side effects or health problems that may occur. The study will track how long patients can continue taking the medication before they need to stop treatment for any reason. This helps researchers understand both the long-term safety and effectiveness of RVU120 in treating these types of cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment continuation

    You will continue receiving RVU120 treatment in the same way as in your previous study, either alone or in combination with other medications

    The treatment will be given in the form of oral capsules

    Your treatment will continue for as long as you are experiencing benefits from it

  2. Step 2

    Regular health monitoring

    Your health status will be regularly monitored to track any side effects

    The medical team will record any adverse events or serious health issues that may occur during treatment

    Regular assessments will determine if you continue to benefit from the treatment

  3. Step 3

    Treatment cycles

    The treatment will be organized in cycles, continuing the same schedule as in your previous study

    You must have completed at least 5 cycles in the previous study to participate in this continuation

  4. Step 4

    Safety requirements

    You should not donate blood during the study and for 28 weeks after your last dose

    You must follow specific safety guidelines regarding pregnancy prevention throughout the study and for 28 weeks after the last dose

    Regular pregnancy tests will be required for female participants who can become pregnant

  5. Step 5

    Study completion

    The study is planned to continue until June 2026

    Treatment may be discontinued if you no longer benefit from it or if safety concerns arise

    After stopping treatment, you will need to follow safety guidelines for 28 weeks

Who can join the trial?

13 criteria

  • Must be currently enrolled in a RVU120 clinical study and receiving treatment for at least 5 cycles
  • Must be showing benefit from the current treatment and expected to continue benefiting according to doctor's assessment
  • Must not have access to other suitable cancer treatments, or if available, they must not be appropriate for the patient
  • For female participants:
    • Must not be pregnant or breastfeeding
    • Must use highly effective contraception during the study and for 28 weeks after the last dose
    • Must have a negative pregnancy test within 3 days before starting treatment
    • For male participants:
      • Must agree not to donate sperm during the study and for 28 weeks after the last dose
      • Must either remain abstinent or use condoms during the study and for 28 weeks after the last dose
      • Must sign the informed consent form before starting any study procedures
      • Must agree not to donate blood during the study and for 28 weeks after the last dose
      • Must be able to:
        • Understand and follow study requirements
        • Comply with treatment schedule
        • Cooperate with all study procedures

Who cannot join the trial?

14 criteria

  • Currently experiencing serious side effects from previous treatments that have not resolved
  • Unable to give informed consent or understand study requirements due to mental or physical conditions
  • Have severe heart conditions (such as uncontrolled high blood pressure, recent heart attack, or severe heart rhythm problems)
  • Have active infections that require treatment
  • Pregnant women or women who are breastfeeding
  • Have other types of cancer that are currently active or requiring treatment
  • Have severe liver problems (liver function tests more than 3 times the normal limit)
  • Have severe kidney problems (poor kidney function requiring dialysis)
  • Taking medications that could interact with the study drug
  • Participating in other clinical trials within the past 30 days
  • History of allergic reactions to similar medications
  • Have conditions that could interfere with taking oral medications
  • Unable to follow study procedures or attend required study visits
  • Have any condition that the study doctor believes would make participation unsafe
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

RVU120 is an investigational medication being studied for continued treatment in patients who have previously shown benefits from it in earlier clinical trials. It is being evaluated both as a standalone treatment and in combination with other therapies. This medication is still in the research phase, and this study aims to provide ongoing access to patients who have responded well to the treatment while monitoring its long-term safety.

What is already known about the treatment

RVU120 - An investigational oral medication currently being studied in clinical trials for the treatment of various blood cancers and solid tumors, particularly focusing on Myelodysplastic Syndrome, Acute Myeloid Leukemia, and advanced solid tumors. The drug belongs to the class of targeted therapies and works by inhibiting specific molecular pathways involved in cancer cell growth and survival. RVU120 is administered orally and is being evaluated both as a standalone treatment and in combination with other therapies, with ongoing studies assessing its safety profile and clinical benefits in patients who have shown positive responses in previous clinical trials.

Investigated diseases

  • Myelodysplastic Syndrome

    A group of blood disorders where blood cells in the bone marrow do not mature properly and remain immature. The condition affects the normal production of blood cells, leading to decreased numbers of one or more types of blood cells. The bone marrow produces abnormal blood cells that fail to function correctly.

  • Metastatic Solid Tumors

    A condition where cancer cells spread from their original location to other parts of the body, forming new tumors. These secondary tumors grow in organs or tissues distant from the primary cancer site. The cancer cells travel through the bloodstream or lymphatic system to reach other areas.

  • Acute Myeloid Leukemia

    A blood cancer that starts in the bone marrow, where immature blood cells develop abnormally and multiply rapidly. These abnormal cells build up in the bone marrow and interfere with the production of normal blood cells. The condition develops quickly, with abnormal white blood cells accumulating and crowding out healthy cells.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521673-14-00Protocol codeROVER-01Estimated enrolment29 patientsSponsorRyvu Therapeutics S.A.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).