^
    20d
    mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial and Ovarian (clinicaltrials.gov)
    P1, N=159, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2025 --> Jun 2026 | Trial primary completion date: Dec 2025 --> Jun 2026
    Trial completion date • Trial primary completion date
    |
    ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA (Breast cancer early onset) • MUC16 (Mucin 16, Cell Surface Associated)
    |
    BRCA mutation
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    Lynparza (olaparib) • Truqap (capivasertib) • vistusertib (AZD2014)
    1m
    Combining brigatinib with mTOR inhibition to effectively treat NF2-SWN-associated and sporadic NF2-deficient meningiomas. (PubMed, Cancer Res Commun)
    We previously generated an orthotopic, NF2-deficient meningioma model using the luciferase-expressing Ben-Men-1 cell line established from a sporadic tumor and identified the multi-kinase inhibitor brigatinib and the mTOR kinase inhibitor INK128 to potently impede tumor growth. As the first NF2-SWN-related meningioma cell line, AG-NF2-Men is a unique reagent for investigating meningioma biology and therapeutics. A clinical trial to evaluate the combination of brigatinib with an mTOR inhibitor in NF2-deficient meningiomas is warranted.
    Journal
    |
    EGFR (Epidermal growth factor receptor) • ERBB3 (V-erb-b2 avian erythroblastic leukemia viral oncogene homolog 3) • NF2 (Neurofibromin 2)
    |
    Alunbrig (brigatinib) • sapanisertib (CB-228)
    1m
    EVERLAST: Everolimus Aging Study (clinicaltrials.gov)
    P2, N=106, Active, not recruiting, University of Wisconsin, Madison | Recruiting --> Active, not recruiting | Trial completion date: Dec 2026 --> Sep 2026 | Trial primary completion date: Dec 2025 --> Sep 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    everolimus
    2ms
    Sapanisertib in Treating Patients With Locally Advanced or Metastatic Bladder Cancer With TSC1 and/or TSC2 Mutations (clinicaltrials.gov)
    P2, N=17, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Nov 2025 --> Nov 2026
    Trial completion date
    |
    TSC2 (TSC complex subunit 2) • TSC1 (TSC complex subunit 1)
    |
    sapanisertib (CB-228)
    2ms
    Testing of the Anti Cancer Drugs CB-839 HCl (Telaglenastat) and MLN0128 (Sapanisertib) in Advanced Stage Non-small Cell Lung Cancer (clinicaltrials.gov)
    P1, N=22, Active, not recruiting, National Cancer Institute (NCI) | N=85 --> 22 | Trial completion date: Jun 2026 --> Nov 2026 | Trial primary completion date: Jun 2026 --> Nov 2025
    Enrollment change • Trial completion date • Trial primary completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS) • KEAP1 (Kelch Like ECH Associated Protein 1) • NFE2L2 (Nuclear Factor, Erythroid 2 Like 2)
    |
    BRAF V600E • KRAS mutation • EGFR mutation • BRAF V600 • BRAF V600K • KEAP1 mutation • NFE2L2 mutation
    |
    Guardant360® CDx • MSK-IMPACT
    |
    sapanisertib (CB-228) • telaglenastat (CB-839)
    2ms
    Genomic and transcriptomic characterization of acute myeloid leukaemia with IL3RA overexpression: Prognostic and therapeutic implications revisited. (PubMed, Br J Haematol)
    Pharmaco-transcriptomic analysis revealed that IL3RA-high AML exhibited selective sensitivity to venetoclax and sapanisertib, suggesting potential synergistic opportunities. In conclusion, IL3RA overexpression defines a clinically and biologically distinct subgroup of AML, with unique therapeutic vulnerabilities. Continued research efforts are warranted to integrate CD123-directed therapies into the upfront AML treatment paradigm.
    Journal
    |
    NPM1 (Nucleophosmin 1) • KMT2A (Lysine Methyltransferase 2A) • CD123 (Interleukin 3 Receptor Subunit Alpha) • NUP214 (Nucleoporin 214) • FUS (FUS RNA Binding Protein) • IL3RA (Interleukin 3 Receptor Subunit Alpha)
    |
    NPM1 mutation
    |
    Venclexta (venetoclax) • sapanisertib (CB-228)
    2ms
    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)
    2ms
    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)
    2ms
    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)
    3ms
    The Bi-steric, mTORC1-Selective Inhibitor, RMC-5552, in Advanced Solid Tumors: A Phase 1 Trial. (PubMed, Clin Cancer Res)
    The success of TM-mediated prophylaxis and the clearance of selected variants in ctDNA are concordant with selective, on-mechanism, antitumor activity following RMC-5552 treatment. These data show that RMC-5552, the first bi-steric mTORC1-selective inhibitor in the clinic, is active at tolerable doses, and that selective inhibition of mTORC1 alleviates mTORC2-mediated hyperglycemia, overcoming a key limitation of prior mTOR inhibitors.
    P1 data • Journal
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1)
    |
    RMC-5552
    4ms
    RMC-5552 Monotherapy in Adult Subjects With Recurrent Glioblastoma (clinicaltrials.gov)
    P1, N=48, Recruiting, Nicholas Butowski | Suspended --> Recruiting
    Enrollment open
    |
    EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1)
    |
    RMC-5552
    4ms
    Extracellular Matrix and Fibroblast Activation in Lymphangioleiomyomatosis. (PubMed, Am J Respir Cell Mol Biol)
    This demonstrates that mTORC1-driven 4E-BP1/eIF4E rapamycin-insensitive translational control overrides transcriptional control of ECM genes. Inhibition by RMC-5552 of ECM and fibroblast activation may result in destruction of CSC-like LAM cells and provide more enduring therapy for LAM patients.
    Journal
    |
    EIF4EBP1 (Eukaryotic translation initiation factor 4E binding protein 1) • TGFB1 (Transforming Growth Factor Beta 1) • COL1A1 (Collagen Type I Alpha 1 Chain) • COL6A1 (Collagen Type VI Alpha 1 Chain)
    |
    RMC-5552