Continued RVU120 Treatment for Patients From an Earlier Study
Gives continued RVU120 treatment to adults from an earlier RVU120 study.
Plain-language title generated from the registry record
Registry title: RVU120 Rollover Study
Key facts
- Where
- Bari, ItalySee the site
- Phase
- Phase 2
Where in Italy
- University Hospital Consorziale PoliclinicoBari, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ryvu Therapeutics SA
- Trial code
- NCT06987058EU 2025-521673-14-00
- Record updated
- 17 September 2026
- Original description
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 full original descriptionShow less
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.
Inclusion: 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.
Exclusion: Concurrent participation in any therapeutic clinical study other than the parent study; Presence of toxicity that cannot be adequately managed.