RVU120 Rollover Study

Launched by RYVU THERAPEUTICS SA · May 15, 2025

Keywords

ClinConnect Summary

The RVU120 Rollover Study is designed for patients with advanced solid tumors, acute myeloid leukemia, or high-risk myelodysplastic syndrome who have been receiving a treatment called RVU120 in a previous clinical trial. This study will allow eligible participants to continue their treatment if they are still benefiting from it and if it is safe for them to do so. The main goal is to ensure that these patients can keep receiving the same treatment while also collecting information about how safe it is and how long they can continue on it.

To be eligible for this study, participants should have already received at least five cycles of RVU120 treatment in the earlier trial and must be showing signs of improvement. They also need to have no access to other available cancer treatments. Participants will continue their treatment as planned, and they will be closely monitored by study doctors. It's important to note that this study is not yet open for recruitment, and all participants will need to agree to specific guidelines regarding their health and participation.

Gender

ALL

Eligibility criteria

• 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. Contraceptive 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:
• • 1. Presence of toxicity that cannot be adequately managed.
• • 2. Concurrent participation in any therapeutic clinical study other than the parent study.