RVU120 Rollover Study | NCT06987058

Studies
RVU120 Rollover Study

NCT06987058

Sponsor

Ryvu Therapeutics SA

Status

Not yet recruiting

Last Update Posted

Sep 24, 2025Actual

Enrollment

10Estimated

Phase

Phase 2

Conditions

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

Interventions

RVU120

Countries

Poland
Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2025-521673-14-00	EU Trial (CTIS) Number

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 15, 2025Estimated

Primary Completion Date

Aug 2026Estimated

Completion Date

Aug 2026Estimated

First Submitted Date

May 15, 2025

First Submission Date that Met QC Criteria

May 15, 2025

First Posted Date

May 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 23, 2025

Last Update Posted Date

Sep 24, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
RVU120 single agent	Experimental	Study intervention is assigned in accordance with the parent protocol and consists of RVU120-based treatment.	Drug: RVU120

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RVU120	Drug	RVU120 is a potent, selective inhibitor of CDK8 and its paralog CDK19	RVU120 single agent

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Head of Clinical Operations	Contact	48538898766		clinicaltrials@ryvu.com

Facility	Status	City	State	ZIP	Country	Contacts
Uniwersyteckie Centrum Kliniczne		Gdansk		80-214	Poland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D015470	Leukemia, Myeloid, Acute
D012008	Recurrence
D009362	Neoplasm Metastasis
D009190	Myelodysplastic Syndromes

Ancestor Terms

ID	Term
D007951	Leukemia, Myeloid
D007938	Leukemia
D009370	Neoplasms by Histologic Type
D009369	Neoplasms

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Browse Branches

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