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ABI-009

DRUG7 trials

Sponsors

Celgene, Aadi Bioscience, Inc., Seattle Children's Hospital, Massachusetts General Hospital, Robert Ramirez

Conditions

Epilepsy IntractableLeigh SyndromeMultiple MyelomaNeuroendocrine TumorsNon-muscle Invasive Bladder Cancer (NMIBC)PEComa, MalignantSolid TumorsTSC1

Phase 1

ABI-009 Trial in Patients With Advanced Non-hematologic Malignancies
CompletedNCT00635284
CelgeneSolid Tumors
Start: 2007-12-01End: 2011-06-01Updated: 2019-10-18
Phase 1/2 Study of ABI-009 in Nonmuscle Invasive Bladder Cancer
CompletedNCT02009332
Aadi Bioscience, Inc.Non-muscle Invasive Bladder Cancer (NMIBC)
Start: 2014-04-09End: 2019-12-01Updated: 2021-06-08
ABI-009 (Nab-rapamycin) for Surgically-Refractory Epilepsy (RaSuRE)
CompletedNCT03646240
Seattle Children's HospitalEpilepsy Intractable
Start: 2018-07-31End: 2022-12-31Updated: 2023-05-06
Safety and Efficacy of ABI-009 (Nab-rapamycin) in Combination With Pomalidomide and Dexamethasone for Relapsed and Refractory Multiple Myeloma
WithdrawnNCT03657420
Massachusetts General HospitalMultiple Myeloma
Start: 2019-05-30End: 2024-09-30Updated: 2019-08-14

Phase 2

A Study to testABI-009 in Patients With Metastatic, Unresectable, Low or Intermediate Grade Neuroendocrine Tumors of the Lung or Gastroenteropancreatic System
TerminatedNCT03670030
Robert RamirezNeuroendocrine Tumors
Start: 2018-11-05End: 2021-02-26Updated: 2021-06-10
ABI-009 (Nab-sirolimus) in Patients With Genetically-confirmed Leigh or Leigh-like Syndrome
WithdrawnNCT03747328
Aadi Bioscience, Inc.Leigh Syndrome
Start: 2022-04-30End: 2025-03-31Updated: 2022-02-01

Unknown Phase

Expanded Access for ABI-009 in Patients With Advanced PEComa and Patients With a Malignancy With Relevant Genetic Mutations or mTOR Pathway Activation
NCT03817515
Aadi Bioscience, Inc.mTOR Pathway Abberation, PEComa, Malignant, TSC1 +1
Updated: 2022-03-16

Related Papers

Abstract C019: Inactivating <i>TSC1</i> and <i>TSC2</i> alterations, co-mutations, and genomic instability in advanced cancers: Analysis of a real-world (RW) patient (pt) population using the Foundation Medicine genomic database
Molecular Cancer Therapeutics2023-12-01
Abstract B003: Real-world (RW) characterization and frequency of <i>TSC1 </i>and/or <i>TSC2 </i>alterations collected from tumor tissue and liquid biopsies from the Tempus genomic database in patients with advanced cancer
Molecular Cancer Therapeutics2023-12-01
<i>nab</i>-Sirolimus for patients with advanced malignant PEComa with or without prior mTOR inhibitors: Biomarker results from AMPECT and an expanded access program.
Journal of Clinical Oncology2022-06-013 citations
Abstract P138: <i>nab</i>-Sirolimus improves mTOR pathway suppression and antitumor activity versus oral mTOR inhibitors in <i>PTEN</i> null bladder cancer (UMUC3) and <i>TSC2</i> null liver cancer (SNU398) xenografts
Molecular Cancer Therapeutics2021-12-014 citations
Institutional experience with <i>nab</i>-sirolimus in patients with malignancies harboring <i>TSC1</i> or <i>TSC2</i> mutations.
Journal of Clinical Oncology2021-05-201 citations
A phase I/II study of albumin-bound rapamycin nanoparticles in the treatment of bacillus calmette-guerin refractory non-muscle invasive transitional cell bladder cancer.
Journal of Clinical Oncology2016-05-206 citations
A phase I/II multi-center study of intravesical nanoparticle albumin-bound rapamycin (ABI-009) in the treatment of BCG refractory non-muscle invasive bladder cancer.
Journal of Clinical Oncology2015-05-207 citations