^
    2d
    Lenalidomide With or Without Idelalisib in Treating Patients With Relapsed or Refractory Mantle Cell Lymphoma (clinicaltrials.gov)
    P1, N=106, Completed, Alliance for Clinical Trials in Oncology | Phase classification: P2 --> P1
    Phase classification
    |
    CCND1 (Cyclin D1) • CD4 (CD4 Molecule) • CD5 (CD5 Molecule) • FCER2 (Fc Fragment Of IgE Receptor II)
    |
    lenalidomide • Zydelig (idelalisib)
    3d
    Pediatric Patients Aged 1 to 6 Years With APDS (clinicaltrials.gov)
    P3, N=16, Active, not recruiting, Pharming Technologies B.V. | Trial completion date: Oct 2026 --> Oct 2028 | Trial primary completion date: Jul 2026 --> Jul 2028
    Trial completion date • Trial primary completion date
    |
    PIK3R1 (Phosphoinositide-3-Kinase Regulatory Subunit 1) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    16d
    Duvelisib Maintenance for the Treatment of Peripheral T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=25, Recruiting, City of Hope Medical Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD4 (CD4 Molecule)
    |
    Copiktra (duvelisib) • ETP-47187
    21d
    PI3Kδ inhibition alters CD8 T cell differentiation and reprograms the tumor microenvironment following adoptive immunotherapy. (PubMed, J Immunol)
    Mechanistically, CAL-101-treated T cells maintain high expression of stemness-associated genes (Tcf7, Slamf6) while resisting expression of genes associated with terminal exhaustion (Tim3, Mt1/2). These findings reveal the mechanisms behind how PI3Kδ inhibition generates T cells capable of establishing and maintaining an antitumor immune response, suggesting a promising strategy for improving adoptive cell therapy outcomes in solid tumors.
    Journal • IO biomarker
    |
    CD8 (cluster of differentiation 8) • CXCL10 (Chemokine (C-X-C motif) ligand 10) • HAVCR2 (Hepatitis A Virus Cellular Receptor 2) • PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta) • SLAMF6 (SLAM Family Member 6) • CXCR3 (C-X-C Motif Chemokine Receptor 3) • TCF7 (Transcription Factor 7)
    |
    Zydelig (idelalisib)
    23d
    Testing the Addition of Copanlisib to Eribulin in Metastatic Triple Negative Breast Cancer (clinicaltrials.gov)
    P1/2, N=24, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: May 2026 --> May 2027
    Trial completion date
    |
    ER (Estrogen receptor) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PGR (Progesterone receptor) • PTEN (Phosphatase and tensin homolog)
    |
    HER-2 amplification • HER-2 negative • PIK3CA mutation • PTEN mutation
    |
    eribulin mesylate • Aliqopa (copanlisib)
    25d
    Add-on parsaclisib for patients with myelofibrosis and suboptimal response to ruxolitinib: a randomized phase 3 study. (PubMed, Oncologist)
    Study results suggested adding parsaclisib to stable-dose ruxolitinib was unlikely to offer clinically meaningful benefits. Further research is needed on the potential of JAK and PI3K inhibitor-based combination therapy for patients with myelofibrosis.
    Clinical • P3 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Jakafi (ruxolitinib) • parsaclisib (INCB50465)
    1m
    J-MIND: To Assess the Safety and Tolerability of Tafasitamab Alone or in Combination With Other Drugs in Japanese Participants With Non-Hodgkins Lymphoma (NHL) (clinicaltrials.gov)
    P1/2, N=72, Active, not recruiting, Incyte Biosciences Japan GK | Trial primary completion date: Dec 2026 --> Jul 2025
    Trial primary completion date
    |
    Rituxan (rituximab) • lenalidomide • doxorubicin hydrochloride • cyclophosphamide • parsaclisib (INCB50465) • Monjuvi (tafasitamab-cxix)
    1m
    Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov)
    P1, N=121, Completed, Incyte Corporation | Active, not recruiting --> Completed
    Trial completion
    |
    itacitinib (INCB039110) • dezapelisib (INCB040093)
    1m
    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
    |
    PD-L1 (Programmed death ligand 1) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog)
    |
    PIK3CA mutation • PTEN mutation
    |
    Opdivo (nivolumab) • Yervoy (ipilimumab) • Aliqopa (copanlisib) • ABP 206 (nivolumab biosimilar)
    1m
    Duvelisib Maintenance After Autologous Stem Cell Transplant in T-Cell Lymphomas (clinicaltrials.gov)
    P2, N=17, Terminated, Washington University School of Medicine | Active, not recruiting --> Terminated; Loss of funding
    Trial termination
    |
    Copiktra (duvelisib)
    1m
    Pediatric Patients Aged 4 to 11 Years With APDS (clinicaltrials.gov)
    P3, N=15, Active, not recruiting, Pharming Technologies B.V. | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Oct 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
    2ms
    NCI10217: Testing the Combination of the Anti-cancer Drugs Copanlisib, Olaparib, and MEDI4736 (Durvalumab) in Patients With Advanced Solid Tumors With Selected Mutations (clinicaltrials.gov)
    P1, N=39, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2026 --> Dec 2026
    Trial completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51 (RAD51 Homolog A) • FANCA (FA Complementation Group A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • CD4 (CD4 Molecule) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin))
    |
    PIK3CA mutation • PTEN mutation • PALB2 mutation • CDK12 mutation • BARD1 mutation
    |
    Lynparza (olaparib) • Imfinzi (durvalumab) • Aliqopa (copanlisib)