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    DRUG:

    Itovebi (inavolisib)

    i
    Other names: GDC-0077, GDC 0077, GDC0077, RG6114, RG-6114, RG 6114, RO7113755, RO 7113755, RO-7113755
    Company:
    Roche
    Drug class:
    PI3Kα inhibitor
    Related drugs:
    1d
    A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche | N=44 --> 80 | Trial completion date: Dec 2030 --> Feb 2030
    Enrollment change • Trial completion date • Trial initiation date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    6d
    Tumor-agnostic Precision Immuno-oncology and Somatic Targeting Rational for You (TAPISTRY) Platform Study (clinicaltrials.gov)
    P2, N=920, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed • Tumor mutational burden • IO biomarker • Pan tumor
    |
    BRAF (B-raf proto-oncogene)
    |
    Tecentriq (atezolizumab) • Rozlytrek (entrectinib) • Alecensa (alectinib) • Kadcyla (ado-trastuzumab emtansine) • Gavreto (pralsetinib) • ipatasertib (RG7440) • belvarafenib (RG6185) • divarasib (RG6330) • Itovebi (inavolisib) • camonsertib (RP-3500)
    7d
    A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=38, Recruiting, Hoffmann-La Roche | N=14 --> 38
    Enrollment change
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    7d
    A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer (clinicaltrials.gov)
    P2, N=60, Recruiting, Hoffmann-La Roche | Active, not recruiting --> Recruiting
    Enrollment open • Trial initiation date
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • letrozole • Itovebi (inavolisib)
    8d
    INAVO122: 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 (clinicaltrials.gov)
    P3, N=230, Recruiting, Hoffmann-La Roche | Trial primary completion date: Sep 2026 --> Dec 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    HER-2 positive • PIK3CA mutation
    |
    tamoxifen • fulvestrant • Itovebi (inavolisib) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf)
    14d
    CO46274: A Phase II Study Evaluating the Efficacy and Safety of Inavolisib plus Ribociclib plus Fulvestrant Versus Placebo plus Ribociclib plus Fulvestrant in Patients with Advanced Breast Cancer (2025-523013-28-00)
    P1/2, N=14, Not yet recruiting, F. Hoffmann-La Roche AG
    New P1/2 trial
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    21d
    A Study to Test Inavolisib Treatments in Participants With Early-Stage, PIK3CA-Mutated Breast Cancer (clinicaltrials.gov)
    P2, N=60, Active, not recruiting, Hoffmann-La Roche | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    ER positive • HER-2 negative • PIK3CA mutation • HER-2 negative + ER positive
    |
    Kisqali (ribociclib) • letrozole • Itovebi (inavolisib)
    21d
    A Study Evaluating Single-agent Inavolisib, Inavolisib Plus Atezolizumab, and Inavolisib Plus Pembrolizumab in PIK3CA-Mutated Cancers (clinicaltrials.gov)
    P1, N=30, Recruiting, Hoffmann-La Roche | Trial completion date: Sep 2026 --> Sep 2028 | Trial primary completion date: Sep 2026 --> Sep 2028
    Trial completion date • Trial primary completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Keytruda (pembrolizumab) • Tecentriq (atezolizumab) • Itovebi (inavolisib)
    23d
    optINAVO: To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche
    Trial initiation date • Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • CDK4 (Cyclin-dependent kinase 4)
    |
    HER-2 negative • PIK3CA mutation
    |
    fulvestrant • Itovebi (inavolisib)
    30d
    A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=80, Recruiting, Hoffmann-La Roche | Not yet recruiting --> Recruiting
    Enrollment open
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor)
    |
    ER positive • PIK3CA mutation
    |
    Kisqali (ribociclib) • fulvestrant • Itovebi (inavolisib)
    1m
    CO45813: A Study to Test Inavolisib Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (2025-521327-67-00)
    P1/2, N=8, Not yet recruiting, F. Hoffmann-La Roche AG
    New P1/2 trial
    |
    docetaxel • Xtandi (enzalutamide) • abiraterone acetate • Itovebi (inavolisib)