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Enrolling by invitationNCT06987058ROVER-01Updated Sep 17, 2026

RVU120 Rollover Study

A Phase 2 interventional study of RVU120 and Ruxolitinib in Advanced Solid Tumors, Acute Myeloid Leukaemia (AML) and High-risk Myelodysplastic Syndrome, sponsored by Ryvu Therapeutics SA. Enrolling by invitation at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-17.

Sponsored by Ryvu Therapeutics SA · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
14
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

This is a multicenter rollover study to provide continued treatment to eligible participants previously enrolled in a RVU120 clinical study and to evaluate the safety of the treatment and record the time on treatment when continued under the same regimen as in the parent study.

To be eligible for this rollover study, participants must be continuing to benefit from their treatment, show an acceptable safety profile, and not have access to commercially available comparator anticancer therapy. Once transitioned to this study, participants will continue with their next planned dose per the regimen of their parent study.

Read the detailed description

Participants may continue treatment until loss of clinical benefit as judged by the investigator, unacceptable toxicity, start of subsequent anticancer therapy, or until any other criterion for withdrawal from the treatment or the study is met.

02

Conditions studied

  • Advanced Solid Tumors
  • Acute Myeloid Leukaemia (AML)
  • High-risk Myelodysplastic Syndrome

Keywords

  • Relapse
  • Refractory
  • Metastatic
  • Advanced
  • Solid Tumor
  • AML
  • Myelodysplastic syndrome
03

In context

Leukemia, Myeloid, Acute

3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.

This study's planned enrollment of 14 is below the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.

Browse Leukemia, Myeloid, Acute studies →

Lead sponsor

Ryvu Therapeutics SA is the lead sponsor of 7 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.
  2. The participant is currently benefiting from, and expected to continue to benefit from, RVU120-based treatment according to the criteria set out in the parent study protocol and according to the judgment of the investigator and sponsor.
  3. The participant does not have access to commercially available comparator anticancer therapy.
  4. use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  5. The participant signed the rollover study ICF prior to any study-related procedure or study data collection.
  6. The participant agrees not to donate blood during study participation and until 28 weeks (\~6.5 months) after the last dose.
  7. The investigator considers the participant to be eligible for participation in the rollover study.

Exclusion criteria

Exclusion Criteria:

  1. Presence of toxicity that cannot be adequately managed.
  2. Concurrent participation in any therapeutic clinical study other than the parent study.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
14 participants (estimated)

Study arms

  • Experimental
    RVU120 single agent

    Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.

    Drug: RVU120

  • Experimental
    RVU120 + Ruxolitinib

    Drug: RVU120 · Drug: Ruxolitinib

Interventions

  • DrugRVU120

    Drug pages: SEL-120 · Romaciclib · Silevertinib

    RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

    Also known as: SEL120

  • Selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2

06

What researchers measure

Primary outcomes

  1. Incidence of Adverse Events (Safety and Tolerability)

    Number and grade of adverse events assessed by CTCAE v5.0

    Time frame: 12 months

Secondary outcomes

  1. Duration of response

    Time from the first administration of RVU120-based treatment in the parent study until discontinuation of RVU120-based treatment for any reason in the rollover study.

    Time frame: 12 months

07

Study locations

7 sites
  • Hôpital l'Archet 1 - CHU de Nice; Service Hématologie Clinique
    Nice, France
  • Hôpital Haut-Lévêque- CHU de Bordeaux, Centre François Magendie, Service d'Hématologie Clinique et Thérapie Cellulaire
    Pessac, France
  • M2M Med Sp. Z o.o.
    Chorzów, Poland
  • CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz
    Gdansk, Poland
  • Pratia Hematologia Sp. z o.o. Pratia Onkologia Katowice
    Katowice, Poland
  • SPZOZ Szpital Uniwersytecki w Krakowie
    Krakow, Poland
  • Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
    Wroclaw, Poland
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06987058
Lead sponsor
Ryvu Therapeutics SA
Responsible party
Sponsor
First posted
May 23, 2025
Start date
Dec 4, 2025
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Sep 17, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

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No contact was published for this record. The registry link below has the sponsor’s details.

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Discussion

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Studies of the drugs tested here: SEL-120 · Romaciclib · Silevertinib

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