Clinical trial • Phase II • Oncology

7,8-DIBROMO-5,6-DIHYDRO-9-METHYL-2-(1-PIPERAZINYL)-4H-IMIDAZO[4,5,1-IJ]QUINOLINE HYDROCHLORIDE for Relapsed or refractory metastatic or advanced solid tumours | Myelofibrosis | High-risk myelodysplastic syndrome (relapsed/refractory) | Acute myeloid leukaemia (with or without NPM1 mutation)

Phase II trial of 7,8-DIBROMO-5,6-DIHYDRO-9-METHYL-2-(1-PIPERAZINYL)-4H-IMIDAZO[4,5,1-IJ]QUINOLINE HYDROCHLORIDE for Relapsed or refractory metastatic or…

Overview

Trial Therapeutic Area: Oncology
Trial Disease: Relapsed or refractory metastatic or advanced solid tumours | Myelofibrosis | High-risk myelodysplastic syndrome (relapsed/refractory) | Acute myeloid leukaemia (with or without NPM1 mutation)
Trial Stage: Phase II
Drug Modality: Small molecule

Key dates

Initial CTIS Submission Date: 19-05-2025
First CTIS Authorization Date: 27-08-2025

Trial design

open-label Phase II trial across 11 sites in Spain, France, Italy and others.

Open Label: Yes
Target Sample Size: 29

Eligibility

Recruits 29 Vulnerable population is selected. The protocol requires that the investigator assesses that the participant or the participant’s legally authorised representative (LAR) understands the requirements of the rollover study and can give informed consent; a LAR may provide consent where appropriate. The participant (or LAR) must sign the rollover ICF prior to any study procedures. No specific assent procedures or age-specific consent documents for minors are provided in the available documentation..

Pregnancy Exclusion: 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.
Vulnerable Population: Vulnerable population is selected. The protocol requires that the investigator assesses that the participant or the participant’s legally authorised representative (LAR) understands the requirements of the rollover study and can give informed consent; a LAR may provide consent where appropriate. The participant (or LAR) must sign the rollover ICF prior to any study procedures. No specific assent procedures or age-specific consent documents for minors are provided in the available documentation.

Inclusion criteria

{"criterion_text":"- The participant is enrolled in a RVU120 clinical study and receiving RVU120-based treatment given alone or in combination for at least 5 cycles.\n- 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.\n- No access to commercially available alternative anticancer therapy or, if avaialable, not clinically appropriate.\n- 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.\n- The participant signed the rollover study ICF prior to any study-related procedure or study data collection.\n- The participant agrees not to donate blood during study participation and until 28 weeks (~6.5 months) after the last dose.\n- 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

{"criterion_text":"- Presence of toxicity that cannot be adequately managed.\n- Concurrent participation in any therapeutic clinical study other than the parent study."}

Endpoints

Primary endpoints

{"endpoint_text":"- Incidence and severity of adverse events (AEs) and serious adverse events (SAEs)","definition_or_measurement_approach":""}

Secondary endpoints

{"endpoint_text":"- 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","definition_or_measurement_approach":"Duration measured as time (calendar time) from first administration of RVU120-based treatment in the parent study to the date of discontinuation of RVU120-based treatment in the rollover study (time-to-event)."}

Recruitment

Planned Sample Size: 29
Recruitment Window Months: 64
Consent Approach: Participants must sign the rollover study informed consent form (ICF) prior to any study-related procedures or data collection. The investigator must confirm the participant or the participant's legally authorised representative (LAR) understands the study and can provide informed consent; LAR consent is allowed where appropriate. Subject information sheets and ICFs are available in multiple languages (English, Spanish, French, Italian, Polish) and country-specific SIS/ICF documents (including 'Pregnant Partner' information) are provided.

Geography

Total Number Of Sites: 11
Total Number Of Participants: 29

Spain

Earliest CTIS Part Ii Submission Date: 29-07-2025
Latest Decision Or Authorization Date: 17-04-2026
Processing Time Days: 262
Number Of Sites: 1
Number Of Participants: 5

Sites

Site Name: Clinica Universidad De Navarra
Department Name: Hematology
Principal Investigator Name: Ana Alfonso Pierola
Principal Investigator Email: aalfonso@unav.es
Contact Person Name: Ana Alfonso Pierola
Contact Person Email: aalfonso@unav.es
Number Of Participants: 5

France

Earliest CTIS Part Ii Submission Date: 26-11-2025
Latest Decision Or Authorization Date: 20-04-2026
Processing Time Days: 145
Number Of Sites: 2
Number Of Participants: 4

Sites

Site Name: Centre Hospitalier Universitaire De Bordeaux
Department Name: Service d'Hematologie et therapie cellulaire
Principal Investigator Name: Sophie Dimicoli-Salazar
Principal Investigator Email: sophie.dimicoli-salazar@chu-bordeaux.fr
Contact Person Name: Sophie Dimicoli-Salazar
Contact Person Email: sophie.dimicoli-salazar@chu-bordeaux.fr

Site Name: Centre Hospitalier Universitaire De Nice
Department Name: Service d'Hematologie clinique (6eme etage)
Principal Investigator Name: Thomas Cluzeau
Principal Investigator Email: cluzeau.t@chu-nice.fr
Contact Person Name: Thomas Cluzeau
Contact Person Email: cluzeau.t@chu-nice.fr

Italy

Earliest CTIS Part Ii Submission Date: 09-01-2026
Latest Decision Or Authorization Date: 17-04-2026
Processing Time Days: 98
Number Of Sites: 1
Number Of Participants: 6

Sites

Site Name: University Hospital Consorziale Policlinico
Department Name: UO Ematologia con Trapianto, Dipartimento di Medicina di Precisione e Rigenerativa e Area Ionica
Principal Investigator Name: Pellegrino Musto
Principal Investigator Email: pellegrino.musto@uniba.it
Contact Person Name: Pellegrino Musto
Contact Person Email: pellegrino.musto@uniba.it
Number Of Participants: 6

Poland

Earliest CTIS Part Ii Submission Date: 28-07-2025
Latest Decision Or Authorization Date: 21-04-2026
Processing Time Days: 267
Number Of Sites: 7
Number Of Participants: 14

Sites

Site Name: Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
Department Name: Oddział Kliniczny Hematologii i Chorób Wewnętrznych
Principal Investigator Name: Tomasz Sacha
Principal Investigator Email: tsacha@su.krakow.pl
Contact Person Name: Tomasz Sacha
Contact Person Email: tsacha@su.krakow.pl

Site Name: Uniwersyteckie Centrum Kliniczne
Department Name: Ośrodek Badań Klinicznych Wczesnych Faz, Klinika Hematologii i Transplantologii
Principal Investigator Name: Witold Prejzner
Principal Investigator Email: wpre@gumed.edu.pl
Contact Person Name: Witold Prejzner
Contact Person Email: wpre@gumed.edu.pl

Site Name: Pratia Hematologia Sp. z o.o.
Department Name: Pratia Onkologia Katowice
Principal Investigator Name: Sebastian Grosicki
Principal Investigator Email: sgrosicki@wp.pl
Contact Person Name: Sebastian Grosicki
Contact Person Email: sgrosicki@wp.pl

Site Name: Uniwersytecki Szpital Kliniczny Nr 1 W Lublinie
Department Name: Klinika Hematoonkologii i Transplantacji Szpiku
Principal Investigator Name: Aneta Szudy- Szczyrek
Principal Investigator Email: anetaszudy@gmail.com
Contact Person Name: Aneta Szudy- Szczyrek
Contact Person Email: anetaszudy@gmail.com

Site Name: M2M Med. Sp. z o.o. Sp. j.
Department Name: M2M Med. Badania
Principal Investigator Name: Katarzyna Dulik
Principal Investigator Email: k.dulik@m2m-badania.pl
Contact Person Name: Katarzyna Dulik
Contact Person Email: k.dulik@m2m-badania.pl

Site Name: Uniwersyteckie Centrum Kliniczne
Department Name: Ośrodek Badań Klinicznych Wczesnych Faz
Principal Investigator Name: Rafał Dziadziuszko
Principal Investigator Email: rafald@gumed.edu.pl
Contact Person Name: Rafał Dziadziuszko
Contact Person Email: rafald@gumed.edu.pl

Site Name: Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego We Wroclawiu
Department Name: Klinika Hematologii, Terapii Komórkowych i Chorób Wewnętrznych
Principal Investigator Name: Tomasz Wróbel
Principal Investigator Email: tomasz_wrobel@wp.pl
Contact Person Name: Tomasz Wróbel
Contact Person Email: tomasz_wrobel@wp.pl

Sponsor

Primary sponsor

Full Name: Ryvu Therapeutics S.A.
Organisation Type: Pharmaceutical company
Country Of Registered Address: Poland

Contract research organisations

Name: AXCELLANT
Responsibilities: Regulatory Affairs, Site Payments, Clinical Trial Systems- CTMS and eTMF, Pharmacovigilance, Patients' travel reimbursement

Third parties

{"country":"Poland","full_name":"AXCELLANT","duties_or_roles":"Regulatory Affairs, Site Payments, Clinical Trial Systems- CTMS and eTMF, Pharmacovigilance, Patients' travel reimbursement","organisation_type":"Health care"}
{"country":"Italy","full_name":"Aptuit (Verona) S.r.l.","duties_or_roles":"IMP manufacturer","organisation_type":"Pharmaceutical company"}
{"country":"Poland","full_name":"Cefea Sp. z o.o. sp.k.","duties_or_roles":"IMP manufacturer","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name: SEL120 monohydrochloride
Active Substance: 7,8-DIBROMO-5,6-DIHYDRO-9-METHYL-2-(1-PIPERAZINYL)-4H-IMIDAZO[4,5,1-IJ]QUINOLINE HYDROCHLORIDE
Modality: Small molecule
Routes Of Administration: ORAL
Route: oral
Authorisation Status: Investigational (not marketing authorised)
Maximum Dose: 250 mg

Investigational Product Name: Jakavi 5 mg tablets
Active Substance: Ruxolitinib
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Marketing authorisation (EU/1/12/773/004)
Maximum Dose: 40 mg

Investigational Product Name: Jakavi 15 mg tablets
Active Substance: Ruxolitinib
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Marketing authorisation (EU/1/12/773/008; EU/1/12/773/009; EU/1/12/773/007 - multiple MA entries)
Maximum Dose: 40 mg

Investigational Product Name: Jakavi 20 mg tablets
Active Substance: Ruxolitinib
Modality: Small molecule
Routes Of Administration: ORAL USE
Route: oral
Authorisation Status: Marketing authorisation (EU/1/12/773/010; EU/1/12/773/011; EU/1/12/773/012 - multiple MA entries)
Maximum Dose: 40 mg

Investigational Product Name: VENETOCLAX
Active Substance: Venetoclax
Modality: Small molecule
Routes Of Administration: ORAL
Route: oral
Maximum Dose: 400 mg

Combination Treatment: Yes

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