^
    2d
    NCI-2022-06209: Testing Copanlisib as a Potential Targeted Treatment in Cancers With PIK3CA Mutations (MATCH-Subprotocol Z1F) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    Aliqopa (copanlisib)
    3d
    EAY131-Z1G: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Loss (MATCH - Subprotocol Z1G) (clinicaltrials.gov)
    P2, N=22, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Jan 2027
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    Aliqopa (copanlisib)
    3d
    EAY131-Z1H: Testing Copanlisib as Potentially Targeting Treatment in Cancers With PTEN Expression (MATCH - Subprotocol Z1H) (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2025 --> Dec 2026
    Trial completion date
    |
    KRAS (KRAS proto-oncogene GTPase) • BRAF (B-raf proto-oncogene) • PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha) • PTEN (Phosphatase and tensin homolog) • HRAS (Harvey rat sarcoma viral oncogene homolog)
    |
    PTEN mutation
    |
    Aliqopa (copanlisib)
    3d
    Clinical Outcomes in Double-Exposed Chronic Lymphocytic Leukemia Patients in Italy. (PubMed, Hematol Oncol)
    Fifty-three patients received treatment after venetoclax: 29/53 (54.7%) received inhibitors (13 cBTKi, 11 idelalisib, 2 BCL2i, 3 non-covalent BTKi), 19/53 (35.8%) received chemoimmunotherapy (CT: 16 intensive, 3 palliative), 5/53 (9.4%) received hematopoietic stem cell transplantation (HSCT). Despite its limitations, this real-world study provides additional insights into double-exposed patients, who still pose a clinical challenge, demonstrating the superior efficacy of inhibitors over alternative treatment options. Enrollment in clinical trial and treatments with novel molecules, if available, may help address this unmet clinical need.
    Clinical data • Journal • IO biomarker
    |
    TP53 (Tumor protein P53) • BCL2 (B-cell CLL/lymphoma 2)
    |
    TP53 mutation • TP53 mutation + Chr del(17p)
    |
    Venclexta (venetoclax) • Zydelig (idelalisib)
    4d
    Combined oral PI3Kδ inhibitor linperlisib and HDAC inhibitor chidamide in relapsed/refractory peripheral T-cell lymphoma: a multicenter phase 1 trial. (PubMed, Leuk Lymphoma)
    With a median follow-up time of 13.0 months, median duration of response (DOR), progression-free survival, and overall survival (OS) were not reached. In conclusion, linperlisib plus chidamide demonstrated a favorable safety profile and encouraging preliminary efficacy in r/r PTCL.
    P1 data • Journal
    |
    PIK3CD (Phosphatidylinositol-4 5-Bisphosphate 3-Kinase Catalytic Subunit Delta)
    |
    Epidaza (chidamide) • Itari (linperlisib)
    11d
    Decoding tamoxifen on idiopathic pulmonary fibrosis: integrating network toxicology and multi-omics. (PubMed, Int J Surg)
    Tamoxifen promotes IPF via miR-432-3p-mediated EGFR suppression, establishing it as a pulmonary toxicant. Integrated network toxicology identifies EGFR as a diagnostic biomarker, highlighting environmental and clinical risks of tamoxifen exposure.
    Journal
    |
    MIR432 (MicroRNA 432)
    |
    tamoxifen • Zydelig (idelalisib)
    17d
    LE 7X01: Leniolisib OLE for Immune Dysregulation in PID (2025-522444-40-00)
    P1/2, N=6, Recruiting, Pharming Technologies B.V.
    New P1/2 trial
    21d
    Leniolisib for Immune Dysregulation in PIDs (clinicaltrials.gov)
    P2, N=12, Active, not recruiting, Pharming Technologies B.V. | Recruiting --> Active, not recruiting | Trial completion date: Oct 2025 --> Nov 2026 | Trial primary completion date: Oct 2025 --> Nov 2026
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    PTEN (Phosphatase and tensin homolog) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • SOCS1 (Suppressor Of Cytokine Signaling 1)
    23d
    Leniolisib for Immune Dysregulation in CVID (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, Pharming Technologies B.V. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    PTEN (Phosphatase and tensin homolog) • CD20 (Membrane Spanning 4-Domains A1) • CTNNB1 (Catenin (cadherin-associated protein), beta 1) • IKZF1 (IKAROS Family Zinc Finger 1) • CTLA4 (Cytotoxic T-Lymphocyte Associated Protein 4) • CARD11 (Caspase Recruitment Domain Family Member 11) • NFKB2 (Nuclear Factor Kappa B Subunit 2) • TNFRSF13C (TNF Receptor Superfamily Member 13C) • CD81 (CD81 Molecule) • SEC61A1 (SEC61 Translocon Subunit Alpha 1) • TNFRSF13B (TNF Receptor Superfamily Member 13B)
    24d
    A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas (clinicaltrials.gov)
    P1/2, N=49, Recruiting, The Lymphoma Academic Research Organisation | Not yet recruiting --> Recruiting
    Enrollment open
    |
    azacitidine • golcadomide (CC-99282) • roginolisib (IOA-244)
    25d
    Copanlisib With Ibrutinib for Patients With Recurrent/ Refractory Primary Central Nervous System Lymphoma (PCNSL) (clinicaltrials.gov)
    P1/2, N=18, Completed, Memorial Sloan Kettering Cancer Center | Active, not recruiting --> Completed | Trial completion date: Jul 2026 --> Feb 2026 | Trial primary completion date: Jul 2026 --> Feb 2026
    Trial completion • Trial completion date • Trial primary completion date
    |
    Imbruvica (ibrutinib) • Aliqopa (copanlisib)
    1m
    Evaluation of the Role of AID-Induced Mutagenesis in Resistance to B-Cell Receptor Pathway Inhibitors in Chronic Lymphocytic Leukemia. (PubMed, Curr Issues Mol Biol)
    Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries, and B-cell receptor (BCR) pathway inhibitors such as idelalisib and ibrutinib are currently established therapies for CLL. We conclude that BCR pathway inhibitors enhance AID mutational activity in CLL, but this does not appear to be directly involved in driving drug resistance. AID-targeted loci may nonetheless serve as biomarkers for monitoring genomic instability during treatment and inform further study.
    Journal • IO biomarker
    |
    BCL2 (B-cell CLL/lymphoma 2) • IRF8 (Interferon Regulatory Factor 8)
    |
    Imbruvica (ibrutinib) • Zydelig (idelalisib)