Evaluation of Metarrestin Dosing and Effects in Adults and Children with Metastatic Solid Tumors

What this Trial Is About

Researchers are studying metarrestin, an investigational drug aimed at treating metastatic solid tumors, including pancreatic, breast, colorectal cancers, and certain pediatric solid tumors other than rhabdomyosarcoma. The study seeks to find the highest safe dose of metarrestin and evaluate whether this dose can shrink tumors. This is a first-in-human Phase I trial focusing on safety and clinical activity in adults and children with advanced cancer whose disease has progressed after standard therapies or who have no other treatment options. Participants will receive metarrestin by mouth in cycles of approximately 28 days. During Phase IA, the maximum tolerated dose MTD is determined using escalating doses, including loading doses on specific days of the first cycle and continued dosing three times a week thereafter. In Phase IB, adults with certain cancers and pediatric patients receive metarrestin at the MTD until disease progression or unacceptable side effects. Treatment involves careful dose adjustments and monitoring. Participants undergo screening tests including blood work, physical exams, tumor documentation or biopsy, heart evaluations, and medication reviews. Treatment monitoring includes hospital stays during the first month, regular clinic visits weekly or biweekly, repeated imaging scans CT or MRI, cognitive assessments, brain activity recordings via electroencephalogram, and questionnaires. Adults may undergo tumor biopsies. After treatment ends, participants have a follow-up visit at 30 days and then phone or email check-ins every six months for life or until study completion.

Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors