Advanced Solid TumorsPhase 2ROVER-01NCT06987058
RVU120 Rollover Study
A Phase 2 study testing RVU120 and Ruxolitinib in people with Advanced Solid Tumors and Acute Myeloid Leukaemia (AML), run by Ryvu Therapeutics SA at 7 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumors, Acute Myeloid Leukaemia (AML), High-risk Myelodysplastic Syndrome
- What is being tested?
- RVU120 and Ruxolitinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 7 sitesin 2 countries
- Study dates
- 4 Dec 2025to Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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
- The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.
- 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.
- The participant does not have access to commercially available comparator anticancer therapy.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant signed the rollover study ICF prior to any study-related procedure or study data collection.
- The participant agrees not to donate blood during study participation and until 28 weeks (~6.5 months) after the last dose.
- The investigator considers the participant to be eligible for participation in the rollover study.
Who cannot join
- Presence of toxicity that cannot be adequately managed.
- Concurrent participation in any therapeutic clinical study other than the parent study.
Trial locations and contacts
7 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 2 countries
Poland5 sites
M2M Med Sp. Z o.o.
Chorzów
CWBK UCK Ośrodek Badań Klinicznych Wczesnych Faz
Gdansk
Pratia Hematologia Sp. z o.o. Pratia Onkologia Katowice
Katowice
SPZOZ Szpital Uniwersytecki w Krakowie
Krakow
Uniwersytecki Szpital Kliniczny-Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Wroclaw
France2 sites
Hôpital l'Archet 1 - CHU de Nice; Service Hématologie Clinique
Nice
Hôpital Haut-Lévêque- CHU de Bordeaux, Centre François Magendie, Service d'Hématologie Clinique et Thérapie Cellulaire
Pessac
About this study
Official title: An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study
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.
- Being tested
- RVU120, Ruxolitinib
- Keywords
- Relapse, Refractory, Metastatic, Advanced, Solid Tumor, AML, Myelodysplastic syndrome
- Medical subject headings
- Leukemia, Myeloid, Acute, Recurrence, Neoplasm Metastasis, Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RVU120Drug
Also called SEL120
RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19
RuxolitinibDrug
Selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2
| Study group | Role | What they receive |
|---|---|---|
| RVU120 single agent | Experimental | Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment. Receives: Drug: RVU120 |
| RVU120 + Ruxolitinib | Experimental | Not described Receives: Drug: RVU120; Drug: Ruxolitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (Safety and Tolerability)
Number and grade of adverse events assessed by CTCAE v5.0
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start4 Dec 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ryvu Therapeutics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987058
- Sponsor's protocol ID
- ROVER-01
- Other IDs
- 2025-521673-14-00, 2025
- Acronym
- ROVER-01
- Status last verified
- Sep 2026
- First submitted
- 15 May 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study
- ClinicalTrials.gov ID
- NCT06987058
- Acronym / sponsor ID
- ROVER-01 / ROVER-01
- Keywords
- Relapse, Refractory, Metastatic, Advanced, Solid Tumor, AML, Myelodysplastic syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Ryvu Therapeutics SAIndustry (pharma, biotech, devices)
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| RVU120 single agent | Experimental | Drug: RVU120Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment. |
| RVU120 + Ruxolitinib | Experimental | Drug: RVU120, Drug: Ruxolitinib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.
- 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.
- The participant does not have access to commercially available comparator anticancer therapy.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant signed the rollover study ICF prior to any study-related procedure or study data collection.
Key exclusion criteria (2 listed)
- Presence of toxicity that cannot be adequately managed.
- Concurrent participation in any therapeutic clinical study other than the parent study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RVU120Also: SEL120RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19 | Drug | RVU120 + Ruxolitinib, RVU120 single agent |
| RuxolitinibSelective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 | Drug | RVU120 + Ruxolitinib |
Primary outcome
Incidence of Adverse Events (Safety and Tolerability)
Time frame: 12 months
Number and grade of adverse events assessed by CTCAE v5.0
1 secondary outcome
Duration of response
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RVU120 and Ruxolitinib in people with Advanced Solid Tumors and Acute Myeloid Leukaemia (AML), run by Ryvu Therapeutics SA at 7 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 7 inclusion and 2 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: enrolling by invitation, as of the sponsor's last update on 17 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 7 sites in Poland, France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of Adverse Events (Safety and Tolerability) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Sep 2026.