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Phase I study of CDK8 inhibitor RVU120 in combination with everolimus in children with recurrent or progressive Group 3 or 4 medulloblastoma; MEDWAY
EU CTIS ID: 2025-524031-39-00
What this study is testing
1. To evaluate the safety and toxicity of RVU120 as a single agent and combined with everolimus when administered to children with recurrent or progressive G3 or G4 medulloblastoma 2. To determine the MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus in children with recurrent or progressive G3 or G4 medulloblastoma.
- Human Pharmacology (Phase I)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Inclusion criteria 1.) Diagnosis: G3 or G4 medulloblastoma that is recurrent or progressive following up-front standard of care therapy. Subgroup must be determined either at diagnosis or recurrence via CLIA-certified methylation testing. 2.) Age (at time of study enrollment): 3 years to ≤18 years 3.) Patients must be able to swallow capsules and/or tablets 4.) BSA: 0.4-2.5 m2 5.) Disease status: Patients with metastatic disease are eligible for both cohorts of the study. a. Dose-finding cohorts b. Efficacy expansion cohort 6.) Prior therapy - Patients must have recovered from the acute treatment related toxicities (defined as ≤ CTCAE v5.0 grade 1 unless otherwise defined in inclusion criteria #7) of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study 7.) Organ function - Patients must have adequate organ and marrow function 8.) Neurologic status 9.) Performance level - Karnofsky Performance Scale (for > 16 years of age) or Lansky Performance Score (for ≤ 16 years of age) 10.) Pregnancy prevention - Patients of childbearing or child fathering potential must be willing to use a medically acceptable form of birth control, which includes abstinence, while being treated on this study. 11.) Informed consent - The patient or parent/guardian is able to understand the consent and is willing to sign a written informed consent document according to institutional guidelines
You likely can't join if
- Exclusion criteria 1.) Pregnancy and lactation status: Pregnant or lactating patients are excluded from this study. Patients of childbearing potential must have a negative serum pregnancy test prior to study enrollment. 2.) Concurrent illness: Patients with any clinically significant unrelated systemic illness (serious infections or significant cardiac, pulmonary, hepatic, or other organ dysfunction), that in the opinion of the investigator would compromise the patient’s ability to tolerate protocol therapy, put them at additional risk for toxicity or would interfere with the study procedures or results. 3.) Concurrent therapy 4.) Recent major surgery: patients that have undergone major surgery including tumor biopsy within 14 days of enrollment. 5.) Malabsorption that requires supplementation or significant bowel or stomach resection that would preclude adequate absorption of RVU120. 6.) Previous therapy with a CDK8 inhibitor or an mTOR inhibitor (such as everolimus, sirolimus, or temsirolimus). 7.) Inability to participate: Patients who in the opinion of the investigator are unwilling or unable to return for required follow-up visits or obtain follow-up studies required to assess toxicity to therapy or to adhere to drug administration plan, other study procedures, and study restrictions.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.