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    DRUG:

    Fyarro (nanoparticle albumin-bound rapamycin)

    i
    Other names: ABI-009, EOC009
    Company:
    EOC Pharma, Kaken Pharma
    Drug class:
    mTORC1 inhibitor
    Related drugs:
    3d
    SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma (clinicaltrials.gov)
    P2, N=41, Recruiting, Sarcoma Alliance for Research through Collaboration | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Fyarro (nanoparticle albumin-bound rapamycin)
    10d
    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 (clinicaltrials.gov)
    P1, N=18, Recruiting, M.D. Anderson Cancer Center | Active, not recruiting --> Recruiting
    Enrollment open
    |
    TSC2 (TSC complex subunit 2) • TSC1 (TSC complex subunit 1)
    |
    gemcitabine • Fyarro (nanoparticle albumin-bound rapamycin)
    1m
    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 (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, M.D. Anderson Cancer Center | N=12 --> 18
    Enrollment change
    |
    TSC2 (TSC complex subunit 2) • TSC1 (TSC complex subunit 1)
    |
    gemcitabine • Fyarro (nanoparticle albumin-bound rapamycin)
    4ms
    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 (clinicaltrials.gov)
    P1, N=12, Active, not recruiting, M.D. Anderson Cancer Center | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    gemcitabine • Fyarro (nanoparticle albumin-bound rapamycin)
    4ms
    Dose-escalation Study to Assess Safety and Pharmacokinetics of Nab-Sirolimus in Patients With Locally Advanced or Metastatic Solid Tumors and Moderate Liver Impairment (clinicaltrials.gov)
    P1, N=28, Recruiting, Aadi Bioscience, Inc. | Trial completion date: Apr 2025 --> Aug 2026 | Trial primary completion date: Apr 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    Fyarro (nanoparticle albumin-bound rapamycin)
    4ms
    EEC-201: Trial of Nab-Sirolimus in Combination With Letrozole in Patients With Advanced or Recurrent Endometrioid Endometrial Cancer (clinicaltrials.gov)
    P2, N=29, Recruiting, Aadi Bioscience, Inc. | Trial completion date: Oct 2026 --> Jun 2027 | Trial primary completion date: Mar 2025 --> Dec 2026
    Trial completion date • Trial primary completion date
    |
    letrozole • Fyarro (nanoparticle albumin-bound rapamycin)
    7ms
    SARC046: A Phase II Trial of Nab-Sirolimus in Patients With Progressing or Symptomatic Epithelioid Hemangioendothelioma (clinicaltrials.gov)
    P2, N=41, Not yet recruiting, Sarcoma Alliance for Research through Collaboration
    New P2 trial
    |
    Fyarro (nanoparticle albumin-bound rapamycin)
    10ms
    NCI-2018-01624: Nab-Sirolimus and Pazopanib Hydrochloride in Treating Patients With Advanced Nonadipocytic Soft Tissue Sarcomas (clinicaltrials.gov)
    P1/2, N=19, Terminated, University of Washington | Trial completion date: Feb 2025 --> Jul 2024 | Active, not recruiting --> Terminated; Study was terminated at completion of the Phase 1 dose escalation due to loss of financial support.
    Trial completion date • Trial termination
    |
    pazopanib • Fyarro (nanoparticle albumin-bound rapamycin)
    11ms
    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) (clinicaltrials.gov)
    P1, N=6, Terminated, Mirati Therapeutics Inc. | N=79 --> 6 | Trial completion date: Jun 2026 --> Dec 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Dec 2024; Business objectives have changed
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase)
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Krazati (adagrasib) • Fyarro (nanoparticle albumin-bound rapamycin)
    12ms
    Wolf in Sheep's Clothing: Taming Cancer's Resistance with Human Serum Albumin? (PubMed, Int J Nanomedicine)
    Drawing from clinical examples, including the success of albumin-bound paclitaxel (Abraxane) and new formulations like Pazenir and Fyarro (for Sirolimus), we identify gaps in current knowledge and propose strategies to optimize albumin-based systems. In conclusion, albumin-based nanoparticles, when tailored with appropriate modifications, have the potential to bypass multidrug resistance and improve the targeting of cancer cells. By enhancing albumin's ability to efficiently deliver therapeutic agents, these carriers represent a promising approach to addressing one of oncology's most persistent challenges, with substantial potential to improve cancer treatment outcomes.
    Review • Journal
    |
    ABCB1 (ATP Binding Cassette Subfamily B Member 1) • CD36 (thrombospondin receptor) • TFRC
    |
    albumin-bound paclitaxel • Fyarro (nanoparticle albumin-bound rapamycin)
    1year
    Nab-Sirolimus and Endocrine Therapy in Recurrent Low Grade Serous Ovarian Cancer (NARETO) (clinicaltrials.gov)
    P2, N=37, Recruiting, University of Oklahoma | Not yet recruiting --> Recruiting
    Enrollment open
    |
    fulvestrant • Fyarro (nanoparticle albumin-bound rapamycin)
    1year
    Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=33, Completed, Children's Oncology Group | Active, not recruiting --> Completed | Trial completion date: Sep 2025 --> Dec 2024
    Trial completion • Trial completion date
    |
    AFP (Alpha-fetoprotein)
    |
    temozolomide • irinotecan • Fyarro (nanoparticle albumin-bound rapamycin)