RVU120 Rollover Study

Phase 2

Not yet recruiting

• Conditions: Advanced Solid Tumors; Acute Myeloid Leukaemia (AML); High-risk Myelodysplastic Syndrome
• Interventions: Drug: RVU120

• Registration Number: NCT06987058
• Lead Sponsor: Ryvu Therapeutics SA

Brief 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.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-15
• Study First Submitted QC: 2025-05-15
• Last Update Submitted: 2025-05-15
• Study First Posted: 2025-05-23
• Last Update Posted: 2025-05-23
• Study Start: 2025-08-07
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
RVU120 single agent	RVU120	Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events (Safety and Tolerability)	12 months	Number and grade of adverse events assessed by CTCAE v5.0

Secondary Outcome Measures

Name	Time	Method
Duration of response	12 months	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.

Trial Locations

Locations (2)

Uniwersyteckie Centrum Kliniczne; 🇵🇱 Gdańsk, Poland

Clinica Universidad de Navarra; 🇪🇸 Pamplona, Spain