This phase I/II trial tests the safety, side effects and best dose of DT2216 in combination with irinotecan and how well it works in treating children, adolescents and young adults with solid tumors and fibrolamellar cancer that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). DT2216 is an anti-apoptotic protein B-cell lymphoma-extra large targeted protein degrader. It may stop the growth of tumor cells by blocking Bcl-xL, a protein needed for tumor cell survival. Irinotecan is in a class of antineoplastic medications called topoisomerase I inhibitors. It blocks a certain enzyme needed for cell division and deoxyribonucleic acid repair and may kill tumor cells. Giving DT2216 in combination with irinotecan may be safe, tolerable, and/or effective in treating children, adolescents and young adults with relapsed or refractory solid tumors or fibrolamellar cancer.
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Incidence of adverse events (AEs)
Timeframe: Up to 30 days after last dose of study drug
Dose-limiting toxicity (DLT)
Timeframe: Up to 21 days
Maximum tolerated dose (MTD)/ recommended phase 2 dose
Timeframe: Up to 21 days
Area under the dose concentration curve of DT2216
Timeframe: Up to 7 hours
Clearance of DT2216
Timeframe: Up to 7 hours
Half-life of DT2216
Timeframe: Up to 7 hours
Area under the dose concentration curve of irinotecan
Timeframe: Up to 7 hours
Clearance of irinotecan
Timeframe: Up to 7 hours
Half-life of irinotecan
Timeframe: Up to 7 hours
Overall response rate (ORR)
Timeframe: At start of treatment until disease progression or recurrence up to 60 months