RVU120 Rollover Study

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

Trial statusNot yet recruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRyvu Therapeutics SA

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Presence of toxicity that cannot be adequately managed.

Concurrent participation in any therapeutic clinical study other than the parent study.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: RVU120 single agentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of Adverse Events (Safety and Tolerability)

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

Time frame

12 months

Secondary outcomes

Duration of response

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.

Time frame

12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ryvu Therapeutics SA

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: