^
    22h
    A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers (clinicaltrials.gov)
    P1, N=30, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
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    PIK3CA mutation
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    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Itovebi (inavolisib)
    5d
    Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Immunotherapy (Nivolumab With or Without Ipilimumab) in Patients With Advanced Solid Cancers That Have Changes in the Following Genes: PIK3CA and PTEN (clinicaltrials.gov)
    P1/2, N=54, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2026 --> May 2027
    Trial completion date • Checkpoint inhibition • IO biomarker
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    PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
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    PIK3CA mutation • PTEN mutation
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    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • ABP 206 (nivolumab biosimilar)
    7d
    INAVO121: A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy (clinicaltrials.gov)
    P3, N=420, Active, not recruiting, Hoffmann-La Roche | Trial primary completion date: Apr 2026 --> Nov 2026
    Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
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    HER-2 negative • PIK3CA mutation
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    Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib) • midazolam hydrochloride
    7d
    InavoPC: A Study to Test Inavolisib Treatment in Participants With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov)
    P2, N=100, Recruiting, Hoffmann-La Roche
    Trial initiation date
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Itovebi (inavolisib)
    7d
    Utilizing Continuous Glucose Monitoring to Characterize and Manage Hyperglycemia in Patients Initiating Alpelisib (clinicaltrials.gov)
    P=N/A, N=8, Completed, HealthPartners Institute | Active, not recruiting --> Completed | N=15 --> 8
    Trial completion • Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 positive • HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
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    Piqray (alpelisib)
    8d
    TARGET-VM: A Trial of Targeted Therapies for Patients With Slow-Flow or Fast-Flow Vascular Malformations (clinicaltrials.gov)
    P2, N=50, Recruiting, Murdoch Childrens Research Institute | Trial completion date: Dec 2026 --> May 2027 | Trial primary completion date: Aug 2026 --> Jan 2027
    Trial completion date • Trial primary completion date
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    Piqray (alpelisib) • Gomekli (mirdametinib)
    8d
    GSH-Responsive Nanoparticles Enhance Hepatocellular Carcinoma Immunotherapy Through Synergistic Effects of Cuproptosis and PI3K Inhibitor Combination. (PubMed, Adv Sci (Weinh))
    In this study, we have designed copper complex nanoparticles (NPCu) and PI3K-AKT-mTOR inhibitor Alpelisib nanoparticles (NPALP) that enhance the efficacy of cuproptosis-based therapies...The combination of these two nanoparticles (NPCu+NPALP) effectively activates the antitumor responses in the tumor microenvironment (TME). When combined with an anti-programmed cell death protein 1 antibody (α-PD-1), NPCu+NPALP significantly inhibits tumor progression and activates antitumor immunity, offering a promising strategy for liver cancer treatment.
    Journal
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    DLAT (Dihydrolipoamide S-Acetyltransferase)
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    Piqray (alpelisib)
    10d
    SGLT2 Inhibitor Dapagliflozin Attenuates Cardiomyocyte Injury and Inflammation Induced by PI3Kα-Selective Inhibitor Alpelisib and Fulvestrant Under Hyperglycemia. (PubMed, Int J Mol Sci)
    Importantly, dapagliflozin markedly attenuated these alterations, supporting a potential cardioprotective role that may extend beyond glycemic control. These findings provide a mechanistic rationale for further investigation of SGLT2 inhibition as a cardiometabolic protective strategy in patients receiving PI3Kα inhibitor-based cancer therapy.
    Journal
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    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • MYD88 (MYD88 Innate Immune Signal Transduction Adaptor) • IL6 (Interleukin 6) • TNFA (Tumor Necrosis Factor-Alpha) • CASP3 (Caspase 3) • CCL2 (Chemokine (C-C motif) ligand 2) • IL18 (Interleukin 18) • IL1B (Interleukin 1, beta) • NLRP3 (NLR Family Pyrin Domain Containing 3)
    |
    HR positive • HER-2 negative • PIK3CA mutation • HR positive + HER-2 negative
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    Piqray (alpelisib) • fulvestrant
    12d
    ASSET: Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer (clinicaltrials.gov)
    P1, N=18, Active, not recruiting, University of Kansas Medical Center | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
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    HR positive • HER-2 negative • PGR positive
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    Piqray (alpelisib) • Trodelvy (sacituzumab govitecan-hziy)
    13d
    Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer (clinicaltrials.gov)
    P1/2, N=32, Recruiting, Faeth Therapeutics
    New P1/2 trial
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 negative
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    fulvestrant • sapanisertib (CB-228) • serabelisib (MLN1117)
    13d
    Combination of Serabelisib and Insulin Suppressing Diet With or Without Nab-paclitaxel in Subjects With Advanced Solid Tumors With PIK3CA Mutations (clinicaltrials.gov)
    P1, N=34, Terminated, Faeth Therapeutics | Completed --> Terminated; Program prioritization
    Trial termination
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    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
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    PIK3CA mutation
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    albumin-bound paclitaxel • serabelisib (MLN1117)