biostudies-literatureCramer SLPediatric Early Phase Clinical Trial Network (PEP-CTN): PEP-CTNNational Cancer InstituteNCI NIH HHSPhase I/Pilot Consortium GrantSolid Malignancy Integrated Translational Science Center: NCTN ITSC-Solid MalignancyCookies for Kids' Cancere70376https://www.ebi.ac.uk/biostudies/studies/S-EPMC11533328biostudies-literatureUnknown13(21)<h4>Background</h4>Nab-sirolimus (ABI-009, nab-rapamycin; Aadi Bioscience Inc. [Aadi]) is a human albumin-bound form of sirolimus nanoparticles, a potent mTOR inhibitor. This phase I trial was conducted to define dose-limiting toxicities (DLT), maximum tolerated or recommended phase II dose (MTD/RP2D), and pharmacokinetics of Nab-sirolimus in combination with temozolomide and irinotecan.<h4>Methods</h4>Using a rolling 6 design, Nab-sirolimus was administered intravenously (IV) on days (D) 1 and 8 of cycle (C) 1. In subsequent cycles, Nab-sirolimus was administered D1 and D8 in combination with temozolomide (125 mg/m²/dose, maximum 250 mg/dose) and irinotecan (90 mg/m²/dose) orally, daily on D1-5. Cycle duration was 21 days. Three dose levels (DL) of Nab-sirolimus wereCancer medicineA Phase 1 Study of ABI-009 (Nab-sirolimus) in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors-A Children's Oncology Group Pediatric Early Phase Clinical Trial Network Study ADVL1514.PMC11533328U10CA180884UM1 CA097452UM1CA097452UM1 CA228823P30 CA015083U10 CA180884UM1CA228823Liu XDenic KFox EMinard CGReid JMCramer SLReddy ATVoss SWeigel BJfalseA Phase 1 Study of ABI-009 (Nab-sirolimus) in Combination With Temozolomide and Irinotecan in Pediatric Patients With Recurrent or Refractory Solid Tumors, Including CNS Tumors-A Children's Oncology Group Pediatric Early Phase Clinical Trial Network Study ADVL1514.<h4>Background</h4>Nab-sirolimus (ABI-009, nab-rapamycin; Aadi Bioscience Inc. [Aadi]) is a human albumin-bound form of sirolimus nanoparticles, a potent mTOR inhibitor. This phase I trial was conducted to define dose-limiting toxicities (DLT), maximum tolerated or recommended phase II dose (MTD/RP2D), and pharmacokinetics of Nab-sirolimus in combination with temozolomide and irinotecan.<h4>Methods</h4>Using a rolling 6 design, Nab-sirolimus was administered intravenously (IV) on days (D) 1 and 8 of cycle (C) 1. In subsequent cycles, Nab-sirolimus was administered D1 and D8 in combination with temozolomide (125 mg/m²/dose, maximum 250 mg/dose) and irinotecan (90 mg/m²/dose) orally, daily on D1-5. Cycle duration was 21 days. Three dose levels (DL) of Nab-sirolimus were2024-01-01T00:00:00Z2024 Nov2026-06-02T18:38:05.758Z2025-04-04T00:29:38.222ZS-EPMC115333283948771110.1002/cam4.70376