NCT06987058

RVU120 Rollover Study

An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Ryvu Therapeutics SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Advanced Solid Tumors
• Acute Myeloid Leukaemia (AML)
• High-risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	RVU120	RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

Timeline

• Start date: 2025-12-15
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2025-05-23
• Last updated: 2025-09-24

Locations

2 sites across 2 countries: Poland, Spain