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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:
    20d
    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)
    21d
    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)
    21d
    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)
    4ms
    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)
    7ms
    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)
    7ms
    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)
    9ms
    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)
    11ms
    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)
    11ms
    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)
    11ms
    Novel Therapeutics in Soft Tissue Sarcoma. (PubMed, Cancers (Basel))
    Examples are the tyrosine kinase inhibitors avapritinib and ripretinib in gastrointestinal stromal tumours (GIST), the immune check point inhibitor atezolizumab in alveolar soft part tissue sarcoma, the γ-secretase inhibitor nirogacestat in desmoid tumours, the NTRK inhibitors larotrectinib and entrectinib in tumours with NTRK fusions, the mTOR inhibitor nab-sirolimus in PEComa, and the EZH-2 inhibitor tazemetostat in epithelioid sarcoma...The challenges in drug development in soft tissue sarcoma are due to the rarity and the molecular heterogeneity of the disease and the fact that many subtypes are associated with complex karyotypes or non-targetable molecular alterations. We believe that progress maybe possible with a better understanding of the complex biology, the development of novel compounds for difficult targets such as proteolysis targeting chimeras (Protacs), the utilisation of modern clinical trial designs, and enhanced collaboration of academia with industry to develop treatments with a strong biologic rationale.
    Review • Journal
    |
    HLA-A (Major Histocompatibility Complex, Class I, A) • MAGEA4 (Melanoma antigen family A, 4) • NTRK (Neurotrophic receptor tyrosine kinase)
    |
    HLA-A*02 • MAGEA4 expression • NTRK fusion
    |
    Tecentriq (atezolizumab) • Vitrakvi (larotrectinib) • Rozlytrek (entrectinib) • Tazverik (tazemetostat) • Ayvakit (avapritinib) • Qinlock (ripretinib) • Fyarro (nanoparticle albumin-bound rapamycin) • Ogsiveo (nirogacestat) • Tecelra (afamitresgene autoleucel)
    1year
    Nanoparticle Albumin-Bound Rapamycin, Temozolomide, and Irinotecan Hydrochloride in Treating Pediatric Patients With Recurrent or Refractory Solid Tumors (clinicaltrials.gov)
    P1, N=33, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2024 --> Sep 2025
    Trial completion date • Combination therapy
    |
    AFP (Alpha-fetoprotein)
    |
    temozolomide • irinotecan • Fyarro (nanoparticle albumin-bound rapamycin)
    over1year
    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, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • Metastases
    |
    gemcitabine • Fyarro (nanoparticle albumin-bound rapamycin)