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OpenTrials
Enrolling by Invitation

NCT Number: NCT06987058

RVU120 Rollover Study

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.

Enrolling by Invitation

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

RVU120

Drug

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

Other names: SEL120

Primary outcomes

  1. Incidence of Adverse Events (Safety and Tolerability)

    Time frame: 12 months

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

Secondary outcomes

  1. Duration of response

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ryvu Therapeutics SA

Industry

Registry information

Official study title

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

Acronym: ROVER-01

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 23, 2025
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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