Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruiting
Participants planned
29
Countries
4
Sites
11
Relapsed / Refractory Metastatic or Advanced Solid Tumors
- To provide continued access to RVU120-based treatment given alone or in combination to participants previously enrolled in a RVU120 clinical study who, at the time of rollover, experience and are expected to continue to experience clinical benefit from that treatment. - To evaluate the safety of RVU120-based treatmen…
Key facts
- Sponsor
- Ryvu Therapeutics S.A.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 3 Dec 2025 → ongoing
- Decision date (initial)
- 2026-01-26
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Ryvu Therapeutics S.A.
External identifiers
- EU CT number
- 2025-521673-14-00
- WHO UTN
- U1111-1322-1439
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
- To provide continued access to RVU120-based treatment given alone or in combination to participants previously enrolled in a RVU120 clinical study who, at the time of rollover, experience and are expected to continue to experience clinical benefit from that treatment.
- To evaluate the safety of RVU120-based treatment when continued under the same regimen as in the parent study
Secondary objectives 1
- To record the time on RVU120-based treatment when continued under the same regimen as in the parent study.
Conditions and MedDRA coding
Relapsed / Refractory Metastatic or Advanced Solid Tumors
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.0 | LLT | 10049280 | Solid tumour | 10029104 |
| 27.0 | PT | 10028533 | Myelodysplastic syndrome | 100000004864 |
| 21.1 | PT | 10000880 | Acute myeloid leukaemia | 100000004864 |
| 20.0 | PT | 10028537 | Myelofibrosis | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-515131-30-00 | An Open-label, Single Agent, Phase I/II Trial Investigating the Safety and Efficacy of RVU120 (SEL120) in Patients with Relapsed / Refractory Metastatic or Advanced Solid Tumors | Ryvu Therapeutics S.A. |
| 2023-505911-19-00 | A Multicenter, Open-Label, Dose-Finding Clinical Trial to Assess the Safety, Pharmacokinetics, Pharmacodynamics, and Clinical Efficacy of RVU120 in Combination with Venetoclax in Participants with Acute Myeloid Leukemia Who Failed Prior Therapy with Venetoclax and a Hypomethylating Agent (RIVER-81) | Ryvu Therapeutics S.A. |
| 2023-505910-10-00 | A Multicenter, Open-Label Clinical Trial of RVU120 in Patients with Relapsed or Refractory High-Risk Myelodysplastic Syndrome or Acute Myeloid Leukemia with or without NPM1 Mutation (RIVER-52) | Ryvu Therapeutics S.A. |
| 2023-509947-29-00 | A phase II, open-label, multicenter study of orally administered RVU120 for the treatment of anemia in patients with lower-risk myelodysplastic neoplasms (MDS) | GCP-Service International West GmbH |
| 2024-511688-27-00 | An Open-Label Clinical Trial of RVU120 as Monotherapy and in Combination with Ruxolitinib in Patients with Intermediate or High-Risk, Primary or Secondary Myelofibrosis (POTAMI-61) | Ryvu Therapeutics S.A. |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 7
- 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.
- No access to commercially available alternative anticancer therapy or, if avaialable, not clinically appropriate.
- Contraceptive use by participants or participant partners should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Female participants: • A female participant is eligible to participate if not pregnant or breastfeeding, and one of the following conditions applies: o Is of NCBP as defined in Appendix 4: Contraceptive and Barrier Guidance. OR o Is of CBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year) and with low user dependency, as described in Appendix 4, during study intervention and until 28 weeks (~6.5 months) after the last dose and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction during this period. The investigator should evaluate the potential for contraceptive method failure (eg, noncompliance, recently initiated) in relationship to the first dose of study intervention. • A participant of CBP must have a negative highly sensitive pregnancy test (urine or serum) as required by local regulations ≤3 days before the first dose of study intervention (Section 8.3.7). o If a urine test cannot be confirmed as negative (eg, an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. • Additional requirements for pregnancy testing during and after study intervention are located in Section 8.3.7. • The investigator is responsible for review of medical history, menstrual history, and recent sexual activity where pregnancy can occur to decrease the risk for inclusion of a participant with an early undetected pregnancy. Male participants: • A male participant is eligible to participate if they agree to all of the following during study intervention and until 28 weeks (~6.5 months) after the last dose: o Refrain from donating sperm. PLUS, either: o Be abstinent from intercourse where pregnancy may occur (abstinent on a long-term and persistent basis) and agree to remain abstinent. OR o Must agree to use a barrier method as detailed below: Agree to use an external condom and should also be advised of the benefit for a CBP partner to use a highly effective method of contraception as a condom may break or leak when having sexual intercourse with a CBP individual who is not currently pregnant. Agree to use an external condom when engaging in any activity that allows for passage of ejaculate to another person.
- 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 by assessing that: • the participant or the participant’s LAR understands the requirements of the rollover study and can give informed consent, • the participant can comply with the dosing requirements of the study intervention and with all other study-related procedures and evaluations, • the participant is not considered to be potentially unreliable and/or not cooperative.
Exclusion criteria 2
- Presence of toxicity that cannot be adequately managed.
- Concurrent participation in any therapeutic clinical study other than the parent study.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)
Secondary endpoints 1
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 14
PRD8279114 · Product
- Active substance
- 78-DIBROMO-56-DIHYDRO-9-METHYL-2-1-PIPERAZINYL-4H-IMIDAZO451-IJQUINOLINE Hydrochloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 71500 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- RYVU THERAPEUTICS S.A.
- Paediatric formulation
- No
- Orphan designation
- No
PRD8279115 · Product
- Active substance
- 78-DIBROMO-56-DIHYDRO-9-METHYL-2-1-PIPERAZINYL-4H-IMIDAZO451-IJQUINOLINE Hydrochloride
- Pharmaceutical form
- CAPSULE
- Route of administration
- ORAL
- Max daily dose
- 250 mg milligram(s)
- Max total dose
- 71500 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Not Authorised
- MA holder
- RYVU THERAPEUTICS S.A.
- Paediatric formulation
- No
- Orphan designation
- No
SUB176260 · Substance
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
SUB176260 · Substance
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
SUB176260 · Substance
- Active substance
- Venetoclax
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 400 mg milligram(s)
- Max total dose
- 84000 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949626 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/010
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949627 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/011
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949619 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/008
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949618 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/007
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949628 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/012
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949634 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/004
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949620 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/009
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949636 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/006
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
PRD3949635 · Product
- Active substance
- Ruxolitinib
- Substance synonyms
- INCB018424, INC-424, INCB-018424
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 40 mg milligram(s)
- Max total dose
- 18240 mg milligram(s)
- Max treatment duration
- 15 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EJ01 — -
- Marketing authorisation
- EU/1/12/773/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Repackaging and relabeling for use in clinical trials
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Ryvu Therapeutics S.A.
- Sponsor organisation
- Ryvu Therapeutics S.A.
- Address
- Ul. Leona Henryka Sternbacha 2
- City
- Cracow
- Postcode
- 30-394
- Country
- Poland
Scientific contact point
- Organisation
- Ryvu Therapeutics S.A.
- Contact name
- Renata Dudziak
Public contact point
- Organisation
- Ryvu Therapeutics S.A.
- Contact name
- Kamil Sitarz
Third parties 3
| Organisation | City, country | Duties |
|---|---|---|
| AXCELLANT ORL-000014611
|
Warsaw, Poland | Code 10, Other, Data management, Code 8 |
| Aptuit (Verona) S.r.l. ORG-100014738
|
Verona, Italy | Code 14, Other |
| Cefea Sp. z o.o. sp.k. ORG-100015378
|
Warsaw, Poland | Code 14, Other |
Locations
4 EU/EEA countries · 11 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 4 | 2 |
| Italy | Authorised, recruitment pending | 6 | 1 |
| Poland | Ongoing, recruiting | 14 | 7 |
| Spain | Authorised, recruitment pending | 5 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Centre Hospitalier Universitaire De Bordeaux
Service d'Hematologie et therapie cellulaire, Avenue De Magellan, 33600, Pessac
Centre Hospitalier Universitaire De Nice
Service d'Hematologie clinique (6eme etage), 151 Route De Saint Antoine, 06200, Nice
University Hospital Consorziale Policlinico
UO Ematologia con Trapianto, Dipartimento di Medicina di Precisione e Rigenerativa e Area Ionica, Piazza Giulio Cesare 11, 70124, Bari
Pratia Hematologia Sp. z o.o.
Pratia Onkologia Katowice, Ul. Tadeusza Kosciuszki 92, 40-519, Katowice
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersyteckie Centrum Kliniczne
Ośrodek Badań Klinicznych Wczesnych Faz, Klinika Hematologii i Transplantologii, Ul. Mariana Smoluchowskiego 17, 80-214, Gdansk
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych, Ul. Wybrzeze Ludwika Pasteura 4, 50-367, Wroclaw
M2M Med. Sp. z o.o. Sp. j.
M2M Med. Badania, Ul. Lwowska 34, 41-500, Chorzow
Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Klinika Hematoonkologii i Transplantacji Szpiku, Ul. Stanislawa Staszica 11, 20-081, Lublin
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Oddział Kliniczny Hematologii i Chorób Wewnętrznych, Ul. Macieja Jakubowskiego 2, 30-688, Cracow
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-04-22 | 2026-04-23 | |||
| Poland | 2025-12-03 | 2025-12-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 24 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ROVER-01_Protocol 2025-521673-14-00_Redacted | 1.1 |
| Recruitment arrangements (for publication) | K1_ROVER-01_EN_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_ROVER-01_ITA_Recruitment arrangements | 1.0 |
| Recruitment arrangements (for publication) | K1_ROVER-01_ITA_Recruitment arrangements_italian | 1 |
| Recruitment arrangements (for publication) | K1_ROVER-01_PL_Recruitment and Informed consent procedure | 1 |
| Recruitment arrangements (for publication) | K1_ROVER-01_Recruitment arrangements | 1.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_FR_SIS and ICF Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_FR_SIS and ICF Pregnant Partner_redacted | 1.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_ITA_SIS and ICF Main_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_ITA_SIS and ICF Pregnant Partner_redacted | 2.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_ITA_SIS and ICF Privacy | 3.0 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_PL_SIS and ICF Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_PL_SIS and ICF_Pregnant Partner_Redacted | 1 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_SP_SIS and ICF Main_Annex 1_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_SP_SIS and ICF Main_Annex 2_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_SP_SIS and ICF Main_redacted | 1.1 |
| Subject information and informed consent form (for publication) | L1_ROVER-01_SP_SIS and ICF_Pregnant Partner_Redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ROVER-01_SmPC_Placeholder_Revised CTIS Transparency Rules | NA |
| Summary of Product Characteristics (SmPC) (for publication) | G2_ROVER-01_SmPC_Placeholder_Revised CTIS Transparency Rules | NA |
| Synopsis of the protocol (for publication) | D1_ROVER-01_Protocol Synopsis_EN_2025-521673-14-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_ROVER-01_Protocol Synopsis_ES_2025-521673-14-00 | 1.1 |
| Synopsis of the protocol (for publication) | D1_ROVER-01_Protocol Synopsis_FR_2025-521673-14 | 1.1 |
| Synopsis of the protocol (for publication) | D1_ROVER-01_Protocol Synopsis_ITA_2025-521673-14 | 1.1 |
| Synopsis of the protocol (for publication) | D1_ROVER-01_Protocol Synopsis_PL_2025-521673-14-00 | 1.1 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2025-05-19 | Poland | Acceptable 2025-08-25
|
2025-08-27 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-04 | Poland | Acceptable | 2025-10-15 |
| 3 | SUBSEQUENT ADDITION OF MSC | APP-3 | 2025-10-15 | Acceptable 2025-08-25
|
2026-01-26 | |
| 4 | SUBSEQUENT ADDITION OF MSC | APP-4 | 2025-10-23 | Acceptable 2025-08-25
|
2026-01-16 | |
| 5 | SUBSTANTIAL MODIFICATION | SM-2 | 2026-02-18 | Poland | Acceptable 2026-04-16
|
2026-04-17 |