RVU120 Rollover Study

NCT06987058 | Not Yet Recruiting Phase 2

• 2 other identifiers: ROVER-012025-521673-14-00
• Study Type: interventional
• Target: 10
• Locations: 2 countries
• Sites: 2

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.

Conditions

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

Keywords

Relapse; Refractory; Metastatic; Advanced; Solid Tumor; AML; Myelodysplastic syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events (Safety and Tolerability)

  Number and grade of adverse events assessed by CTCAE v5.0

  12 months

Secondary Outcomes (1)

• Duration of response

  12 months

Study Arms (1)

RVU120 single agent

EXPERIMENTAL

Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.

Drug: RVU120

Interventions

RVU120 DRUG

RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19

Also known as: SEL120

RVU120 single agent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Ryvu Therapeutics SA: lead

Study Sites (2)

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214, Poland

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Recurrence; Neoplasm Metastasis; Myelodysplastic Syndromes

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Bone Marrow Diseases

Central Study Contacts

Head of Clinical Operations

CONTACT

48538898766; clinicaltrials@ryvu.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: December 15, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: September 24, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1); ES (1)