MEDWAY
Phase I Study of CDK8 Inhibitor RVU120 in Combination With Everolimus in Children With Recurrent or Progressive Group 3 or 4 Medulloblastoma
Sponsor study identifier
interventional
48
1 country
1
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study will determine the safety and tolerability of RVU120 as a single agent and in combination with the mTOR inhibitor everolimus in children with recurrent or progressive G3 or G4 medulloblastoma and provide preliminary data regarding the efficacy of this treatment approach.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 5, 2026
Actual (reported)September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
October 8, 2026
Actual (reported)June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Frequency and nature of AEs, SAEs and DLTs according to CTCAE v5.0 in RVU120 monotherapy and combination therapy with everolimus
Assessment of adverse events (AEs), serious adverse events (SAEs), and dose-limiting toxicities (DLTs) occurring during treatment with RVU120 monotherapy and RVU120 combined with everolimus. All events will be collected and graded according to CTCAE v5.0.
From Day1 to 30 days after last dose
MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus
Determination of the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of RVU120 administered as a single agent and in combination with everolimus in children with recurrent or progressive Group 3 or Group 4 medulloblastoma. MTD will be defined based on the occurrence of dose-limiting toxicities (DLTs) according to CTCAE v5.0 during the predefined DLT evaluation period. RP2D will be established based on MTD, overall safety profile, and clinical tolerability.
During Cycle 1 (DLT evaluation period; each cycle is 28 days)
Peak Plasma Concentration (Cmax) of RVU120
Day 1 and Day 14 of Cycle 1 (each cycle is 28 days); Day 1 of subsequent cycles
Time to Peak Plasma Concentration (Tmax) of RVU120
Day 1 and Day 14 of Cycle 1; Cycle 4 Day 1; Cycle 7 Day 1; and every 4 cycles thereafter through study completion (up to 2 years).
Area Under the Plasma Concentration-Time Curve (AUC) of RVU120
Day 1 and Day 14 of Cycle 1; Cycle 4 Day 1; Cycle 7 Day 1; and every 4 cycles thereafter through study completion (up to 2 years).
Terminal Elimination Half-Life (t½) of RVU120
Day 1 and Day 14 of Cycle 1; Cycle 4 Day 1; Cycle 7 Day 1; and every 4 cycles thereafter through study completion (up to 2 years).
Everolimus Trough Concentration (Ctrough) During Combination Therapy
Pre-dose on Cycle 1 Day 1 and Cycle 1 Day 7, and before each subsequent treatment cycle through study completion (up to 2 years).
Change in Tumor Pharmacodynamic (PD) Markers (IHC)
Baseline (Screening) and Cycle 4 Day 1 (each cycle is 28 days)
Transcriptomic Changes in Tumor Tissue (RNAseq)
Baseline tumor sample (Screening) and post-treatment tumor biopsy at protocol-specified on-treatment time point (e.g., Cycle 4 Day 1).
CDK8- and mTOR-Dependent Phosphorylation Events (IHC)
Baseline tumor sample (Screening) and post-treatment tumor biopsy at protocol-specified on-treatment time point (e.g., Cycle 4 Day 1).
Monotherapy dose finding arm - patient will be treated with single agent RVU120 with interpatient dose escalation to determine MTD and/or RP2D
Combination therapy dose finding arm - patient will be treated with RVU120 in combination therapy with everolimus
Experimantal - RVU120
RVU120 + everolimus
Instytut "Pomnik - Centrum Zdrowia Dziecka", Centrum Wsparcia Pediatrycznych Badań Klinicznych
Warsaw, Masovian Voivodeship, 04-730, Poland
Bożenna Dembowska-Bagińska
The Children's Memorial Health Institute
Aleksander Wiśniewski
The Children's Memorial Health Institute
Magdalena Kozłowska
The Children's Memorial Health Institute
First Submitted
August 5, 2026
First Posted
October 8, 2026
Study Start
September 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
June 2033
Expansion cohort - patient will be treated with RVU120 in combination therapy with everolimus - efficacy cohort
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
June 2033
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
October 8, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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