Clinical trial NCT06987058: RVU120 Rollover Study
Official title: An Open-label Multicenter Rollover Study to Provide Continued Treatment to Participants Previously Enrolled in a RVU120 Clinical Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Advanced Solid Tumors
Acute Myeloid Leukaemia (AML)
High-risk Myelodysplastic Syndrome
Keywords: Relapse
Refractory
Metastatic
Advanced
Solid Tumor
AML
Myelodysplastic syndrome
Lead sponsor: Ryvu Therapeutics SA
Sponsor class: INDUSTRY
First posted: 2025-05-23
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Group Assignment
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Adverse Events (Safety and Tolerability)
timeFrame: 12 months
Secondary outcomes:
measure: Duration of response
timeFrame: 12 months
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
Study officials:
References: