A Study of Avutometinib for People With Solid Tumor Cancers (NCT06104488) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study of Avutometinib for People With Solid Tumor Cancers
United States3 participantsStarted 2023-10-20
Plain-language summary
The purpose of this study is to find out whether avutometinib is a safe treatment for advanced or recurrent solid tumor cancers in children and young adults. Researchers will look for the highest dose of avutometinib that is safe and cause few or mild side effects.
Who can participate
Age range
3 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Histologically confirmed diagnosis of a pediatric tumor including CNS tumors with activating MAP kinase pathway alterations including but not limited to BRAF/ARAF/CRAF fusions or mutations, KRAS/NRAS/HRAS alterations, PTPN11 or SOS1/2 mutations and/or loss of function alterations in NF1. This will be performed at the enrolling institution and central review is not required OR
. Participants with a clinical or molecularly confirmed (germline alteration positive) diagnosis of NF1 with symptomatic inoperable plexiform neurofibromas and recurrent/progressive low-grade gliomas are eligible and may enroll without tissue/biopsy confirmation.
. Patients with recurrent optic pathway gliomas are eligible if they have clinical progression (defined as new or worsening neurologic symptoms including visual dysfunction, as defined below):
. Anti-cancer agents not known to be myelosuppressive: ≥ 7 days
. Anti-cancer and cytotoxic agents known to be myelosuppressive: ≥ 14 days
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 1 trial focused on measuring the safety of avutometinib, which means it's still in an early stage — can you help me understand what that means for how much is already known about its risks and whether it might actually shrink my tumor?
2Since this trial specifically includes CNS tumors and conditions like low-grade glioma, optic pathway gliomas, NF1, and plexiform neurofibromas, is my particular diagnosis a close enough match that it would even be worth exploring, or is there a better-suited option?
3The trial status is 'active not recruiting,' meaning they're no longer enrolling new patients — are there other avutometinib studies or similar MEK-pathway trials that are currently open and might be appropriate to look into instead?
4Given that this drug targets MAP kinase pathway mutations, would it make sense to have my tumor tested for those specific genetic markers before we consider any trial like this, and has that testing already been done in my case?
5Before considering an experimental Phase 1 drug, is there a standard-of-care treatment for my condition that you'd recommend trying first, and how would that decision affect my eligibility for future trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. Immunotherapies (including antibodies, interleukins, interferons, etc.): ≥ 21 days
. Adoptive cellular therapies (including modified T cells, vaccines, etc.): ≥ 42 days
. Autologous stem cell infusion (boost, no conditioning): ≥ 21 days
Exclusion criteria
. Any history of congestive heart failure
. Left ventricular ejection fraction (LVEF) \< 50% or below the institutional standard lower limit, whichever is higher, as determined by multiple gated acquisition (MUGA) scan or Trans-thoracic echocardiography (TTE)
. QTc \> 470 msec regardless of sex (using Bazett formula) on screening ECG (using triplicate ECGs), history of Torsades de Pointes, or a history of congenital long QT syndrome.