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nab-sirolimus

DRUG12 trials

Sponsors

Aadi Bioscience, Inc., Mirati Therapeutics Inc., M.D. Anderson Cancer Center, University of Oklahoma, Sarcoma Alliance for Research through Collaboration

Conditions

Advanced CancerAdvanced Solid TumorCancerCancer MetastaticColorectal Cancer MetastaticEndometrial CancerEndometrioid Endometrial CancerEndometrioid Tumor

Phase 1

Phase 1/1b Study With Nab-sirolimus for Patients With Severe Pulmonary Arterial Hypertension
CompletedNCT02587325
Aadi Bioscience, Inc.Pulmonary Hypertension
Start: 2017-04-01End: 2022-09-16Updated: 2024-11-25
Nab-Sirolimus in Combination With FOLFOX & BEV as 1st Line Therapy in Patients With Advanced or Metastatic Colorectal Cancer
CompletedNCT03439462
Aadi Bioscience, Inc.Colorectal Cancer Metastatic
Start: 2018-07-01End: 2022-08-26Updated: 2024-01-02
Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment
RecruitingNCT05661461
Aadi Bioscience, Inc.Advanced Solid Tumor, Tumor, Tumor, Solid
Start: 2022-11-23End: 2026-08-01Target: 28Updated: 2025-11-13
Adagrasib in Combination With Nab-Sirolimus in Patients With Advanced Solid Tumors and Non-Small Cell Lung Cancer With a KRAS G12C Mutation (KRYSTAL -19)
TerminatedNCT05840510
Mirati Therapeutics Inc.Advanced Cancer, Malignant Neoplastic Disease, Metastatic Cancer +2
Start: 2023-08-07End: 2024-12-27Updated: 2025-04-25
A Phase I Trial of Combination Gemcitabine and Nab-Sirolimus in Advanced Leiomyosarcomas or Advanced Soft-Tissue Sarcomas With TSC2 or TSC1 Loss-of-function Mutations or Deletions
RecruitingNCT06308419
M.D. Anderson Cancer CenterLeiomyosarcoma, Soft-tissue Sarcomas
Start: 2024-08-14End: 2031-02-01Target: 18Updated: 2026-02-25

Phase 2

A Phase 2 Study of Nab-sirolimus (ABI-009) in Patients With Advanced Malignant PEComa
CompletedNCT02494570
Aadi Bioscience, Inc.Malignant PEComa
Start: 2015-10-31End: 2022-04-30Updated: 2023-04-07
Nab-sirolimus in Recurrent High Grade Glioma and Newly Diagnosed Glioblastoma
CompletedNCT03463265
Aadi Bioscience, Inc.High Grade Recurrent Glioma and Newly Diagnosed Glioblastoma
Start: 2018-08-01End: 2022-08-26Updated: 2023-11-07
Phase 2 Basket Trial of Nab-sirolimus in Patients With Malignant Solid Tumors With Pathogenic Alterations in TSC1/TSC2 Genes (PRECISION 1)
Active, not recruitingNCT05103358
Aadi Bioscience, Inc.Advanced Cancer, Advanced Solid Tumor, Cancer +18
Start: 2022-02-15End: 2025-12-31Target: 120Updated: 2024-06-03
Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer
RecruitingNCT05997017
Aadi Bioscience, Inc.Cancer, Endometrial Cancer, Endometrioid Endometrial Cancer +3
Start: 2023-12-28End: 2027-06-30Target: 29Updated: 2025-11-13
Trial of Nab-sirolimus in Patients With Well-differentiated Neuroendocrine Tumors (NETs) of the Gastrointestinal Tract, Lung, or Pancreas Who Have Not Received Prior Treatment With mTOR Inhibitors
CompletedNCT05997056
Aadi Bioscience, Inc.Gastrointestinal Neuroendocrine Tumor, NET, Neuroendocrine Tumors +2
Start: 2023-10-20End: 2025-10-03Updated: 2026-08-25
Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO)
Active, not recruitingNCT06494150
University of OklahomaLow Grade Ovarian Serous Adenocarcinoma
Start: 2024-12-26End: 2029-09-01Target: 37Updated: 2026-06-12
SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma
RecruitingNCT07104331
Sarcoma Alliance for Research through CollaborationEpithelioid Hemangioendothelioma (EHE)
Start: 2026-02-24End: 2029-08-30Target: 41Updated: 2026-05-26

Related Papers

SARC046: A phase II trial of nab-sirolimus in patients with progressing or symptomatic epithelioid hemangioendothelioma.
Journal of Clinical Oncology2026-05-28
Phase I trial of combination gemcitabine (gem) and nab-sirolimus (nab-S) in advanced leiomyosarcomas (LMS) or advanced soft-tissue sarcomas (STS) with <i>TSC1/2</i> alterations: Preliminary results.
Journal of Clinical Oncology2026-05-27
A phase 2, open-label, single-arm, prospective, multicenter study of <i>nab</i>-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer.
Journal of Clinical Oncology2024-06-01
Abstract 1212: Impact of KEAP1/STK11 co-mutations and NRF2 signaling on resistance to adagrasib in advanced NSCLC
Cancer Research2024-03-221 citations
Phase II Trial of <i>nab-</i>Sirolimus in Patients With Advanced Malignant Perivascular Epithelioid Cell Tumors (AMPECT): Long-Term Efficacy and Safety Update
Journal of Clinical Oncology2024-03-0127 citations
Abstract A018: A phase 2, open-label, single-arm, prospective, multicenter study of <i>nab</i>-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer
Clinical Cancer Research2024-03-01
Abstract B010: Response to treatment with <i>nab</i>-sirolimus among patients with primary uterine tumors: A subgroup analysis from AMPECT
Clinical Cancer Research2024-03-01
Abstract B011: Phase 2, multicenter, open-label basket trial of <i>nab</i>-sirolimus for malignant solid tumors harboring pathogenic inactivating alterations in <i>TSC1</i> and <i>TSC2</i> (PRECISION I)
Clinical Cancer Research2024-03-01
PRECISION 1: A phase 2, multicenter, open-label basket trial of <i>nab</i>-sirolimus for malignant solid tumors harboring pathogenic inactivating alterations in <i>TSC1</i> and <i>TSC2</i>.
Journal of Clinical Oncology2024-01-29
Analysis of inactivating <i>TSC1</i> and <i>TSC2</i> alterations in advanced genitourinary (GU) cancers from a real-world patient population in the Foundation Medicine genomic database.
Journal of Clinical Oncology2024-01-29
Phase 2 study of <i>nab-</i>sirolimus in patients with well-differentiated and advanced/metastatic neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas.
Journal of Clinical Oncology2024-01-20
PRECISION 1: A phase 2, multicenter, open-label basket trial of <i>nab</i>-sirolimus for malignant solid tumors harboring pathogenic inactivating alterations in <i>TSC1</i> and <i>TSC2</i>.
Journal of Clinical Oncology2024-01-20
Real-world analysis of patients with advanced gastrointestinal (GI) cancers harboring inactivating <i>TSC1</i> and <i>TSC2</i> alterations using the Foundation Medicine genomic database.
Journal of Clinical Oncology2024-01-20
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 LB_B12: Phase 2, multicenter, open-label basket trial of <i>nab</i>-Sirolimus for malignant solid tumors harboring pathogenic inactivating alterations in <i>TSC1</i> and <i>TSC2</i> (PRECISION I)
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
TP009/#1495  A phase 2, open-label, single-arm, prospective, multi-center study of nab-sirolimus plus letrozole in advanced or recurrent endometrioid endometrial cancer
2023-11-01
Phase 2, multicenter, open-label basket trial of <i>nab</i>-sirolimus for patients with malignant solid tumors harboring pathogenic inactivating alterations in <i>TSC1</i> or <i>TSC2</i> genes (PRECISION I).
Journal of Clinical Oncology2023-06-011 citations
Abstract LB288: Biomarker analysis from AMPECT correlating response to <i>nab</i>-sirolimus with <i>TSC1</i> and <i>TSC2</i> inactivating alterations
Cancer Research2023-04-141 citations
Abstract CT057: Phase 2, multicenter open-label basket trial of <i>nab</i>-sirolimus for patients with inactivating alterations in <i>TSC1</i> or <i>TSC2</i> (PRECISION I)
Cancer Research2023-04-14

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