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    DRUG:

    Itovebi (inavolisib)

    i
    Company:
    Roche
    Drug class:
    PI3Kα inhibitor
    Related drugs:
    Apply
    Tumor-Agnostic Precision Immuno-Oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (NCT04589845)
    Phase 2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/18/2021
    Primary completion :
    09/25/2032
    Completion :
    09/25/2032
    BRAF
    |
    Tecentriq (atezolizumab) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Gavreto (pralsetinib) • ipatasertib (RG7440) • belvarafenib (RG6185) • idasanutlin (RG7388) • divarasib (RG6330) • Itovebi (inavolisib) • camonsertib (RP-3500)
    Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer (GeparPiPPa) (NCT05306041)
    Phase 2
    German Breast Group
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    01/02/2023
    Primary completion :
    10/01/2026
    Completion :
    01/01/2027
    HER-2 • PIK3CA • PGR
    |
    HER-2 positive • PIK3CA mutation • PGR positive
    |
    Herceptin (trastuzumab) • tamoxifen • Perjeta (pertuzumab) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer (MORPHEUS BC) (NCT04802759)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/17/2025
    Initiation :
    06/22/2021
    Primary completion :
    11/30/2027
    Completion :
    11/30/2027
    ER • CDK4
    |
    HER-2 positive • ER positive
    |
    Herceptin (trastuzumab) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • everolimus • Verzenio (abemaciclib) • Kisqali (ribociclib) • ipatasertib (RG7440) • Itovebi (inavolisib) • giredestrant (GDC-9545) • Pegasys (pegylated interferon α -2a) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • samuraciclib (CT7001)
    A Study to Evaluate the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer (INAVO122) (NCT05894239)
    Phase 3
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    07/28/2023
    Primary completion :
    09/28/2026
    Completion :
    12/28/2032
    HER-2 • PIK3CA
    |
    HER-2 positive • PIK3CA mutation
    |
    tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation (GO42144) (NCT04449874)
    Phase 1
    Genentech, Inc.
    Recruiting
    Last update posted :
    02/14/2025
    Initiation :
    07/29/2020
    Primary completion :
    02/28/2026
    Completion :
    02/28/2026
    KRAS
    |
    KRAS mutation • KRAS G12C • KRAS G12
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Tecentriq (atezolizumab) • erlotinib • divarasib (RG6330) • Itovebi (inavolisib) • migoprotafib (RLY-1971)
    A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer (Morpheus-TNBC) (NCT03424005)
    Phase 1/2
    Hoffmann-La Roche
    Recruiting
    Last update posted :
    02/10/2025
    Initiation :
    03/30/2018
    Primary completion :
    05/03/2028
    Completion :
    05/03/2028
    HER-2 • PD-L1 • PIK3CA
    |
    PD-L1 expression • PIK3CA mutation
    |
    Avastin (bevacizumab) • Tecentriq (atezolizumab) • carboplatin • gemcitabine • Enhertu (fam-trastuzumab deruxtecan-nxki) • capecitabine • Verzenio (abemaciclib) • albumin-bound paclitaxel • Kisqali (ribociclib) • fulvestrant • Halaven (eribulin mesylate) • letrozole • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Actemra IV (tocilizumab) • ladiratuzumab vedotin (SGN-LIV1A) • selicrelumab (RG7876)
    A Study Evaluating the Efficacy and Safety of Inavolisib + Palbociclib + Fulvestrant vs Placebo + Palbociclib + Fulvestrant in Patients With PIK3CA-Mutant, Hormone Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (INAVO120) (NCT04191499)
    Phase 2/3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    02/04/2025
    Initiation :
    01/29/2020
    Primary completion :
    09/29/2023
    Completion :
    09/30/2030
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Ibrance (palbociclib) • fulvestrant • Itovebi (inavolisib)
    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 (INAVO121) (NCT05646862)
    Phase 3
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    01/29/2025
    Initiation :
    06/07/2023
    Primary completion :
    03/30/2029
    Completion :
    03/30/2029
    HER-2 • PIK3CA • CDK4
    |
    HER-2 negative • PIK3CA mutation
    |
    Piqray (alpelisib) • fulvestrant • Itovebi (inavolisib)
    To Evaluate the Safety, Tolerability, and Pharmacokinetics of Inavolisib Single Agent in Participants With Solid Tumors and in Combination With Endocrine and Targeted Therapies in Participants With Breast Cancer (GO39374) (NCT03006172)
    Phase 1
    Genentech, Inc.
    Active, not recruiting
    Last update posted :
    12/20/2024
    Initiation :
    12/13/2016
    Primary completion :
    12/31/2026
    Completion :
    12/31/2026
    HER-2 • PIK3CA
    |
    HER-2 negative • PIK3CA mutation
    |
    Herceptin (trastuzumab) • Ibrance (palbociclib) • Perjeta (pertuzumab) • fulvestrant • letrozole • metformin • Itovebi (inavolisib)
    A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors (BOUQUET) (NCT04931342)
    Phase 2
    Hoffmann-La Roche
    Active, not recruiting
    Last update posted :
    06/13/2024
    Initiation :
    10/07/2021
    Primary completion :
    05/30/2028
    Completion :
    12/31/2028
    ER
    |
    Avastin (bevacizumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Ibrance (palbociclib) • paclitaxel • Kadcyla (ado-trastuzumab emtansine) • Cotellic (cobimetinib) • Verzenio (abemaciclib) • cyclophosphamide • letrozole • ipatasertib (RG7440) • triptorelin • goserelin acetate • Itovebi (inavolisib) • giredestrant (GDC-9545)
    A PoC Study to Evaluate Treatments' Efficacy by Monitoring MRD Using ctDNA in HR-positive/HER2-negative EBC Population (MiRaDoR) (NCT05708235)
    Phase 2
    MedSIR
    Recruiting
    Last update posted :
    05/29/2024
    Initiation :
    04/01/2024
    Primary completion :
    12/30/2028
    Completion :
    12/30/2028
    HER-2 • PIK3CA
    |
    HR positive • HER-2 negative • PIK3CA mutation
    |
    Verzenio (abemaciclib) • Itovebi (inavolisib) • giredestrant (GDC-9545)
    Circulating Tumor DNA Enriched, Genomically Directed Post-neoadjuvant Trial for Patients With Residual Triple Negative Breast Cancer (PERSEVERE) (NCT04849364)
    Phase 2
    Bryan Schneider, MD
    Recruiting
    Last update posted :
    11/13/2023
    Initiation :
    08/24/2021
    Primary completion :
    01/31/2029
    Completion :
    01/31/2034
    HER-2 • PGR
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Talzenna (talazoparib) • capecitabine • Itovebi (inavolisib)
    Genomics Guided Targeted Post-neoadjuvant Therapy in Patients With Early Breast Cancer (COGNITION-GUIDE) (NCT05332561)
    Phase 2
    German Cancer Research Center
    Recruiting
    Last update posted :
    07/06/2023
    Initiation :
    06/29/2023
    Primary completion :
    03/01/2030
    Completion :
    12/01/2030
    HER-2 • PD-L1 • PIK3CA • TMB • BRCA1 • BRCA2 • PARP1 • TACSTD2
    |
    HER-2 positive • TMB-H • HR positive • MSI-H/dMMR • HER-2 negative • PIK3CA mutation • HER-2 exon 20 insertion • PALB2 mutation • HR positive + HER-2 negative • HER-2 exon 20 mutation
    |
    Herceptin (trastuzumab) • Lynparza (olaparib) • Tecentriq (atezolizumab) • Perjeta (pertuzumab) • ipatasertib (RG7440) • Trodelvy (sacituzumab govitecan-hziy) • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)