7,8-DIBROMO-5,6-DIHYDRO-9-METHYL-2-(1-PIPERAZINYL)-4H-IMIDAZO[4,5,1-IJ]QUINOLINE HYDROCHLORIDE for Medulloblastoma (recurrent or progressive)

Inclusion criteria

• {"criterion_text":"- 1.)\tDiagnosis: 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.\n- 2.) Age (at time of study enrollment): 3 years to ≤18 years\n- 3.) Patients must be able to swallow capsules and/or tablets\n- 4.) BSA: 0.4-2.5 m2\n- 5.) Disease status: Patients with metastatic disease are eligible for both cohorts of the study.\n a. Dose-finding cohorts\n b. Efficacy expansion cohort\n- 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\n- 7.) Organ function - Patients must have adequate organ and marrow function\n- 8.) Neurologic status\n- 9.) Performance level - Karnofsky Performance Scale (for > 16 years of age) or Lansky Performance Score (for ≤ 16 years of age)\n- 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.\n- 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"}

Exclusion criteria

• {"criterion_text":"- 1.)\tPregnancy 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.\n- 2.)\tConcurrent 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.\n- 3.)\tConcurrent therapy\n- 4.)\tRecent major surgery: patients that have undergone major surgery including tumor biopsy within 14 days of enrollment.\n- 5.)\tMalabsorption that requires supplementation or significant bowel or stomach resection that would preclude adequate absorption of RVU120.\n- 6.)\tPrevious therapy with a CDK8 inhibitor or an mTOR inhibitor (such as everolimus, sirolimus, or temsirolimus).\n- 7.)\tInability 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."}

Primary endpoints

• {"endpoint_text":"- 1. Frequency and nature of AEs, SAEs and DLTs according to CTCAE v5.0 in RVU120 monotherapy and combination therapy with everolimus","definition_or_measurement_approach":"AEs/SAEs/DLTs assessed and graded according to CTCAE v5.0 in RVU120 monotherapy and in combination with everolimus."}
• {"endpoint_text":"- 2. MTD and/or RP2D of RVU120 as a single agent and in combination with everolimus","definition_or_measurement_approach":"MTD/RP2D determined using dose‑finding (dose‑escalation) cohorts for RVU120 as monotherapy and RVU120 combined with everolimus."}

Secondary endpoints

• {"endpoint_text":"- 1. PK parameters of RVU120 as a single agent and in combination with everolimus, including Cmax, AUCτ, tmax, AUC0 - ∞, t1/2","definition_or_measurement_approach":"Plasma PK parameters to be measured for RVU120 (Cmax, AUCτ, tmax, AUC0-∞, t1/2) per standard PK sampling and analysis."}
• {"endpoint_text":"- 2. Ctrough of everolimus in combination with RVU120","definition_or_measurement_approach":"Measurement of everolimus trough concentrations (Ctrough) when given in combination with RVU120 at tested dose levels."}
• {"endpoint_text":"- 3. Overall response rate (ORR), duration of response, progression-free survival (PFS), and overall survival (OS) in accordance with RAPNO guidelines, where applicable, stratified by molecular subgroup (G3 vs. G4) and MYC or MYCN expression in combination therapy of RVU120 and everolimus","definition_or_measurement_approach":"Efficacy outcomes assessed per RAPNO guidelines where applicable; analyses stratified by molecular subgroup (G3 vs G4) and by MYC/MYCN expression."}

Poland

Earliest CTIS Part Ii Submission Date

19-03-2026

Latest Decision Or Authorization Date

23-04-2026

Processing Time Days

35

Number Of Sites

1

Number Of Participants

48

Primary sponsor

Full Name

Instytut Pomnik Centrum Zdrowia Dziecka

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Poland

Third parties

• {"country":"","full_name":"100 % Agencja Badań Medycznych","duties_or_roles":"Monetary support / funding","organisation_type":""}