{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"submitter":["Cramer SL"],"funding":["Pediatric Early Phase Clinical Trial Network (PEP-CTN): PEP-CTN","National Cancer Institute","NCI NIH HHS","Phase I/Pilot Consortium Grant","Solid Malignancy Integrated Translational Science Center: NCTN ITSC-Solid Malignancy","Cookies for Kids' Cancer"],"pagination":["e70376"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC11533328"],"repository":["biostudies-literature"],"omics_type":["Unknown"],"volume":["13(21)"],"pubmed_abstract":["<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/m<sup>2</sup>/dose, maximum 250 mg/dose) and irinotecan (90 mg/m<sup>2</sup>/dose) orally, daily on D1-5. Cycle duration was 21 days. Three dose levels (DL) of Nab-sirolimus were"],"journal":["Cancer medicine"],"pubmed_title":["A 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."],"pmcid":["PMC11533328"],"funding_grant_id":["U10CA180884","UM1 CA097452","UM1CA097452","UM1 CA228823","P30 CA015083","U10 CA180884","UM1CA228823"],"pubmed_authors":["Liu X","Denic K","Fox E","Minard CG","Reid JM","Cramer SL","Reddy AT","Voss S","Weigel BJ"],"additional_accession":[]},"is_claimable":false,"name":"A 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.","description":"<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/m<sup>2</sup>/dose, maximum 250 mg/dose) and irinotecan (90 mg/m<sup>2</sup>/dose) orally, daily on D1-5. Cycle duration was 21 days. Three dose levels (DL) of Nab-sirolimus were","dates":{"release":"2024-01-01T00:00:00Z","publication":"2024 Nov","modification":"2026-06-02T18:38:05.758Z","creation":"2025-04-04T00:29:38.222Z"},"accession":"S-EPMC11533328","cross_references":{"pubmed":["39487711"],"doi":["10.1002/cam4.70376"]}}