^
    10d
    HEMA-MED: A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Recruiting, iOnctura | Initiation date: May 2025 --> Nov 2025
    Trial initiation date
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    2ms
    TRIUMPH: Tebentafusp and Roginolisib in Uveal Melanoma to Prolong T-cell Homeostasis (clinicaltrials.gov)
    P1, N=8, Recruiting, St Vincent's Hospital, Sydney
    New P1 trial
    |
    Kimmtrak (tebentafusp-tebn) • roginolisib (IOA-244)
    5ms
    Roginolisib (IOA-244) With Venetoclax and Rituximab for Refractory/Relapsed Chronic Lymphocytic Leukemia (CLL) (clinicaltrials.gov)
    P1/2, N=64, Recruiting, Jennifer R. Brown, MD, PhD | Not yet recruiting --> Recruiting
    Enrollment open
    |
    clonoSEQ
    |
    Venclexta (venetoclax) • Rituxan (rituximab) • Truxima (rituximab-abbs) • roginolisib (IOA-244)
    6ms
    Novel PI3kδ inhibitor roginolisib synergizes with venetoclax in hematologic malignancies. (PubMed, Haematologica)
    These findings support proof of concept for roginolisib development in hematological malignancies as a single agent or in combination with venetoclax. A clinical trial of roginolisib with venetoclax and an anti-CD20 antibody is initiating in CLL.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • MCL1 (Myeloid cell leukemia 1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Venclexta (venetoclax) • roginolisib (IOA-244)
    6ms
    A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=49, Not yet recruiting, The Lymphoma Academic Research Organisation
    New P1/2 trial
    |
    azacitidine • golcadomide (CC-99282) • roginolisib (IOA-244)
    7ms
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination With Dostarlimab With or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Recruiting, iOnctura | Not yet recruiting --> Recruiting
    Enrollment open • IO biomarker
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)
    7ms
    HEMA-MED: A Study of Roginolisib in Combination With Ruxolitinib in Patients With Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Recruiting, iOnctura | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    9ms
    HEMA-MED: A Study of Roginolisib in Combination with Ruxolitinib in Patients with Myelofibrosis (MF) Who Are Unresponsive to JAK Inhibitors (clinicaltrials.gov)
    P1/2, N=26, Not yet recruiting, iOnctura
    New P1/2 trial
    |
    Jakafi (ruxolitinib) • roginolisib (IOA-244)
    9ms
    PULMO-01: A Study of Roginolisib (IOA-244) in Combination with Dostarlimab with or Without Docetaxel in Metastatic Non Small-cell Lung Cancer (NSCLC) Patients (clinicaltrials.gov)
    P1/2, N=45, Not yet recruiting, iOnctura
    New P1/2 trial
    |
    IL7R (Interleukin 7 Receptor)
    |
    docetaxel • Jemperli (dostarlimab-gxly) • roginolisib (IOA-244)
    10ms
    OCULE-01: A Randomised Phase II Study of Roginolisib in Patients with Advanced/metastatic Uveal Melanoma (clinicaltrials.gov)
    P2, N=85, Recruiting, iOnctura | Not yet recruiting --> Recruiting
    Enrollment open
    |
    roginolisib (IOA-244)
    1year
    OCULE-01: Study of Roginolisib in UM Patients (clinicaltrials.gov)
    P2, N=85, Not yet recruiting, iOnctura
    New P2 trial • Metastases
    |
    roginolisib (IOA-244)
    over1year
    DIONE-01: A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients With Metastatic Cancers (clinicaltrials.gov)
    P1; Trial completion date: Apr 2024 --> Mar 2025 | Trial primary completion date: Sep 2023 --> Mar 2025
    Combination therapy • Trial completion date • Trial primary completion date • Metastases
    |
    PD-L1 (Programmed death ligand 1) • BRAF (B-raf proto-oncogene) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    PD-L1 IHC 22C3 pharmDx • VENTANA PD-L1 (SP263) Assay
    |
    cisplatin • Bavencio (avelumab) • Jakafi (ruxolitinib) • pemetrexed • roginolisib (IOA-244)