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Acute Myeloid LeukemiaPhase 1NCT04021368

RVU120 in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

A Phase 1 study testing RVU120(SEL120) in people with Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome, run by Ryvu Therapeutics SA at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the recommended dose for further clinical development and assessment of safety, tolerability… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RVU120(SEL120)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
10 sitesin 2 countries
Study dates
4 Sep 2019to 21 May 2024
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All the following criteria must be met for a patient to be eligible for the study:
  • Written informed consent provided prior to any study-related procedure.
  • Age ≥18 years.
  • AML diagnosis according to the 2016 World Health Organisation (WHO) classification (Arber et al. 2016) with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care; or Myelodysplastic Syndrome (MDS) diagnosis according to the 2016 WHO classification (Arber et al. 2016) with high-risk disease per the Revised International Prognostic Scoring System (IPSS-R >4.5) and with relapsed or refractory disease with no available therapy who have exhausted the applicable standard of care.
  • Eastern Cooperative Oncology Group (ECOG) performance score of 0-2.
  • Patients must have been off anti-cancer treatment prior to study.
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  • Patients must have recovered from the toxic effects of previous treatments.
  • Peripheral white blood cell (WBC) count <10x10^9/L; Platelet count >10,000/μL; Serum albumin ≥ 30g/L (3.0g/dL); Normal coagulation (elevated INR, prothrombin time or APTT <1.3 x ULN acceptable); AST and ALT ≤3x ULN; Total bilirubin ≤1.5 x ULN; Creatinine clearance ≥60 mL/min (Cockcroft-Gault formula);
  • Adequate cardiac function
  • Life expectancy of at least 12 weeks.
  • For females of childbearing potential (FCBP), a negative pregnancy test must be confirmed before enrolment. FCBP must commit to use a highly effective method of contraception during study participation and until 6 months after the last dose of study drug. Females must also refrain from donating blood or egg (ovum) during the same time period.
  • For males, an effective barrier method of contraception must be used during study participation until 6 months after the last dose of study drug, if the patient is sexually active with a FCBP. Males must also refrain from donating blood or sperm during the same time-period.
  • Investigator considers the patient to be suitable for participation in the clinical study

Who cannot join

  • Active central nervous system (CNS) leukemia.
  • Previous treatment with CDK8-targeted therapy.
  • Patients who have undergone major surgery within 28 days prior to first dose of study drug.
  • Hematopoietic stem cell transplant within 120 days prior to first dose of study drug.
  • Active acute graft versus host disease (GVHD)
  • Infections and acute inflammatory conditions
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  • Known seropositivity or history of HIV
  • Known positive test of / or known active diagnosis of COVID-19 viral infection
  • Ongoing significant liver disease
  • Impairment of gastrointestinal function or gastrointestinal disease
  • Ongoing drug-induced pneumonitis.
  • Concurrent participation in another investigational clinical trial.
  • Taking any medications, herbal supplements or other substances (including smoking) that are known to be strong inhibitors or inducers of CYP1A2 or that can prolong Q wave to T wave (QT) interval and/or cause torsade de pointes within less than 5 half-lives, prior to first dose of study drug.
  • Significant cardiac dysfunction or poorly controlled angina.
  • Currently taking drugs that are documented, in the drug package insert, to have a risk of causing prolonged QTc or torsades de pointes (TdP) within 5 half-lives prior to first dose of study drug.
  • Personal or family history of serious ventricular arrhythmia, or QT interval corrected for heart rate (QTc) ≥470 ms (Bazett's formula).
  • Any other prior or current medical condition or extenuating circumstance that, in the Investigator's opinion, could jeopardize patient safety or interfere with the objectives of the study.
  • Prior history of malignancies other than AML or MDS, unless the patient has been free of the disease for 5 years or more prior to Screening.
  • Pregnant or breast-feeding females.

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

United States5 sites

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Sylvester Comprehensive Cancer Center, University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • Tennessee Oncology

    Nashville, Tennessee, 37203

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Poland5 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Świętokrzyskie Centrum Onkologii, Klinika Hematologii i Transplantacji Szpiku

    Kielce, Świętokrzyskie Voivodeship, 25-734

  • MICS Centrum Medyczne Toruń

    Torun, 87-100

  • Instytut Hematologii i Transfuzjologii

    Warsaw, 02-776

  • Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii

    Wroclaw, 53-413

Other trials in Poland

About this study

Official title: A Phase Ib Study of RVU120 (SEL120) in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome

This first-in-human study will evaluate RVU120 (SEL120), a novel small molecule CDK8/19 inhibitor, in patients with Acute Myeloid Leukemia (AML) or High-risk Myelodysplastic Syndrome (HR-MDS), in terms of selection of the recommended dose for further clinical development and assessment of safety, tolerability, preliminary anti-leukemic activity, as well as pharmacokinetic and pharmacodynamic profiles.

Read the detailed description

The study will determine the recommended phase II dose (RP2D) and safety of RVU120 (SEL120) given as monotherapy over a range of dose-levels, following a closely controlled dose escalation study design.

Being tested
RVU120(SEL120)
Keywords
Acute Myeloid Leukemia, Myelodysplastic Syndrome, CDK8/19 Inhibitor, RVU120 (SEL120), Clinical Trial, Phase Ib
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RVU120(SEL120)Drug

    RVU120(SEL120) will be administered as a single oral dose every other day (q.o.d.) for a total of 7 doses i.e. on Days 1, 3, 5, 7, 9, 11 and 13, in a 3-week treatment cycle.

Study groups in NCT04021368
Study groupRoleWhat they receive
RVU120(SEL120)ExperimentalThe first part of the study consists of dose-escalation cohorts where patients will receive ascending doses of RVU120(SEL120) to determine the recommended dose (RD) for further clinical development. The second part of the study is an enrichment cohort where additional 6 to 20 patients will be treated with RVU120(SEL120) to support the evaluation of the RD.
Receives: Drug: RVU120(SEL120)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recommended dose (RD)

    The RD will be determined using all available data, which will include dose limiting toxicities (DLTs) and other toxicities, signs of anti-leukemic activity, pharmacokinetic and pharmacodynamic characteristics.

    Measured: Up to 2 years

  2. Incidence of Adverse Events (Safety and Tolerability)

    Safety and tolerability profile will be assessed by Common Terminology Criteria for Adverse Events v5.0 and summarized by type, frequency, and severity of adverse events.

    Measured: Up to 2 years

Secondary outcomes (5)

  1. The Maximum Observed Concentration (C[max])

    Pharmacokinetic profile of RVU120(SEL120) will be characterized using the Maximum Observed Concentration (C[max]).

    Measured: Up to 2 years

  2. The Terminal Half-life (t[1/2])

    Pharmacokinetic profile of RVU120(SEL120) will be characterized using the Terminal Half-life (t[1/2]).

    Measured: Up to 2 years

  3. The Area Under the Curve (AUC)

    Pharmacokinetic profile of RVU120(SEL120) will be characterized using the Area Under the Curve (AUC).

    Measured: Up to 2 years

  4. The Volume of Distribution at Steady State (Vss)

    Pharmacokinetic profile of RVU120(SEL120) will be characterized using the Volume of Distribution at Steady State (Vss).

    Measured: Up to 2 years

  5. Anti-leukemic activity

    Anti-leukemic activity will be assessed by AML or MDS Response Criteria (Döhner et al., 2017, or Cheson et al., 2006, respectively).

    Measured: Up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jul 2019
  2. Study start4 Sep 2019
  3. Primary completion21 May 2024
  4. Study completion21 May 2024

Why it stopped: RPD2 has been identified

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Dose escalating Cohorts with a safety expansion Cohort
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04021368
Sponsor's protocol ID
CLI120-001
Status last verified
Sep 2026
First submitted
12 Jul 2019
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RVU120(SEL120) in people with Acute Myeloid Leukemia and High-risk Myelodysplastic Syndrome, run by Ryvu Therapeutics SA at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: RPD2 has been identified). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recommended dose (RD) (time frame: Up to 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04021368.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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