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    BIOMARKER:

    UGT1A1 mutation

    i
    Other names: UGT1A1, UDP glucuronosyltransferase family 1 member A1, GNT1, UGT1, UDPGT, UGT1A, HUG-BR1, BILIQTL1, UDPGT 1-1
    Entrez ID:
    54658
    Related biomarkers:
    Mutation
    3ms
    HOVON150AML: A Study of Ivosidenib or Enasidenib in Combination With Induction Therapy and Consolidation Therapy, Followed by Maintenance Therapy in Patients With Newly Diagnosed Acute Myeloid Leukemia or Myedysplastic Syndrome EB2, With an IDH1 or IDH2 Mutation, Respectively, Eligible for Intensive Chemotherapy (clinicaltrials.gov)
    P3, N=968, Active, not recruiting, Stichting Hemato-Oncologie voor Volwassenen Nederland | Recruiting --> Active, not recruiting | Trial completion date: May 2034 --> Sep 2034 | Trial primary completion date: Oct 2024 --> Apr 2027
    Enrollment closed • Trial completion date • Trial primary completion date • Combination therapy
    |
    FLT3 (Fms-related tyrosine kinase 3) • IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH1 mutation • IDH2 mutation • FLT3 mutation • IDH1 R132 • UGT1A1*1*1 • FLT3 mutation + IDH1 mutation • IDH2 R140 • IDH2 R172 • UGT1A1 mutation
    |
    Tibsovo (ivosidenib) • Idhifa (enasidenib)
    8ms
    A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P1/2, N=60, Recruiting, M.D. Anderson Cancer Center | Trial completion date: Sep 2027 --> Sep 2025
    Trial completion date • Combination therapy
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    Rituxan (rituximab) • lenalidomide • Ezharmia (valemetostat)
    8ms
    IDHENTIFY: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (clinicaltrials.gov)
    P3; Active, not recruiting --> Completed
    Trial completion
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • UGT1A1 mutation
    |
    Abbott RealTime IDH2
    |
    cytarabine • azacitidine • Idhifa (enasidenib) • hydroxyurea
    10ms
    A Study of Perpetrator Drug Interactions of Enasidenib in AML Patients (clinicaltrials.gov)
    P1, N=40, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • UGT1A1 mutation
    |
    Idhifa (enasidenib) • midazolam hydrochloride
    10ms
    IDHENTIFY: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (clinicaltrials.gov)
    P3; Trial completion date: Dec 2023 --> Mar 2024
    Trial completion date
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • UGT1A1 mutation
    |
    Abbott RealTime IDH2
    |
    cytarabine • azacitidine • Idhifa (enasidenib) • hydroxyurea
    10ms
    AG-221-C-001: Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation (clinicaltrials.gov)
    P1/2, N=345, Completed, Celgene | Active, not recruiting --> Completed
    Trial completion
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • Chr t(15;17) • UGT1A1 mutation
    |
    Idhifa (enasidenib)
    12ms
    A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma (clinicaltrials.gov)
    P2, N=1, Terminated, Hackensack Meridian Health | N=43 --> 1 | Trial completion date: May 2026 --> Nov 2023 | Recruiting --> Terminated | Trial primary completion date: May 2025 --> Nov 2023; Low Accrual
    Enrollment change • Trial completion date • Trial termination • Trial primary completion date • Combination therapy
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    Darzalex (daratumumab) • pomalidomide
    1year
    Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer (clinicaltrials.gov)
    P1; Phase classification: P1b --> P1
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Ezharmia (valemetostat)
    1year
    Genetic variations underlying Gilbert syndrome and HBV infection outcomes: a cross-sectional study. (PubMed, Front Genet)
    We showed that the accumulation of UGT1A1 variants or the rarity of the variation is associated with a better prognosis, and the effect magnitude correlates with UGT1A1 deficiency. This study demonstrates the therapeutic potential of host UGT1A1 variations underlying GS against HBV infection outcomes.
    Observational data • Journal
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*28 • UGT1A1*1*1 • UGT1A1 mutation • UGT1A1 wild-type
    1year
    AG120-221-C-001: Safety Study of AG-120 or AG-221 in Combination With Induction and Consolidation Therapy in Participants With Newly Diagnosed Acute Myeloid Leukemia (AML) With an IDH1 and/or IDH2 Mutation (clinicaltrials.gov)
    P1, N=153, Active, not recruiting, Institut de Recherches Internationales Servier | Trial completion date: Jul 2023 --> Jul 2024
    Trial completion date • Combination therapy
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • Chr t(15;17) • UGT1A1 mutation
    |
    cytarabine • etoposide IV • Tibsovo (ivosidenib) • daunorubicin • Idhifa (enasidenib) • idarubicin hydrochloride • mitoxantrone
    over1year
    Fruquintinib With mFOLFOX6/FOLFIRI as First-Line Therapy for Conversion Surgery in mCRC (clinicaltrials.gov)
    P2, N=92, Recruiting, Fudan University
    New P2 trial • Surgery
    |
    BRAF (B-raf proto-oncogene) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    BRAF mutation • RAS mutation • UGT1A1*28 • UGT1A1*1*1 • UGT1A1 mutation
    |
    5-fluorouracil • oxaliplatin • irinotecan • Fruzaqla (fruquintinib) • leucovorin calcium
    over1year
    Liposomal Irinotecan Based FOLFIRI With Bevacizumab in First-line Treatment of Advanced Colorectal Cancer (clinicaltrials.gov)
    P2, N=50, Recruiting, Fudan University
    New P2 trial • Metastases
    |
    BRAF (B-raf proto-oncogene) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    BRAF mutation • RAS mutation • UGT1A1*28 • UGT1A1*1*1 • UGT1A1 mutation
    |
    Avastin (bevacizumab) • 5-fluorouracil • leucovorin calcium
    over1year
    Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov)
    P1, N=55, Recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2028 --> Jul 2029 | Trial primary completion date: Jul 2023 --> Jul 2024
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    MYC rearrangement • BCL6 rearrangement • BCL2 rearrangement • UGT1A1*1*1 • UGT1A1 mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone • Polivy (polatuzumab vedotin-piiq)
    over1year
    A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P1/2, N=60, Recruiting, M.D. Anderson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    Rituxan (rituximab) • lenalidomide • Ezharmia (valemetostat)
    over1year
    A single-center retrospective analysis of the efficacy and safety of a modified regimen of irinotecan plus S-1 (IRIS) with molecular targeting agents as second-line chemotherapy in Japanese patients with recurrent or nonresectable colorectal cancer. (PubMed, J Gastrointest Oncol)
    As the second-line chemotherapy for stage IV recurrent or nonresectable colorectal cancer, our hospital started a modified treatment regimen comprising of irinotecan plus S-1 (IRIS) [tegafur/gimeracil/oteracil (S-1)] plus molecular targeting agents (MTAs), i.e., an epidermal growth factor receptor (EGFR) inhibitor such as panitumumab (P-mab) or cetuximab (C-mab) or vascular endothelial growth factor (VEGF) inhibitor such as bevacizumab (B-mab) since October 2012. Diarrhea and perforation were also common in the left-sided group. This second-line modified IRIS regimen with MTAs is safe and effective and results in good PFS and OS.
    Retrospective data • Journal
    |
    BRAF (B-raf proto-oncogene) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    BRAF mutation • RAS wild-type • UGT1A1*1*1 • UGT1A1 mutation
    |
    Avastin (bevacizumab) • Erbitux (cetuximab) • Vectibix (panitumumab) • irinotecan • Teysuno (gimeracil/oteracil/tegafur)
    over1year
    Ivosidenib and Combination Chemotherapy for the Treatment of IDH1 Mutant Relapsed or Refractory Acute Myeloid Leukemia (clinicaltrials.gov)
    P1, N=25, Recruiting, Northwestern University | Not yet recruiting --> Recruiting | Trial completion date: Dec 2022 --> Dec 2028 | Trial primary completion date: Dec 2021 --> Dec 2026
    Enrollment open • Trial completion date • Trial primary completion date
    |
    IDH1 (Isocitrate dehydrogenase (NADP(+)) 1) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH1 R132 • UGT1A1*1*1 • UGT1A1 mutation
    |
    cytarabine • Tibsovo (ivosidenib) • fludarabine IV • Neupogen (filgrastim) • Starasid (cytarabine ocfosfate)
    over1year
    Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov)
    P1, N=55, Recruiting, National Cancer Institute (NCI) | N=32 --> 55
    Enrollment change • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    MYC rearrangement • BCL6 rearrangement • BCL2 rearrangement • UGT1A1*1*1 • UGT1A1 mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone • Polivy (polatuzumab vedotin-piiq)
    over1year
    AG-221-C-001: Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation (clinicaltrials.gov)
    P1/2, N=345, Active, not recruiting, Celgene | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date • Metastases
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • Chr t(15;17) • UGT1A1 mutation
    |
    Idhifa (enasidenib)
    almost2years
    Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer (clinicaltrials.gov)
    P1b; Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Feb 2023
    Combination therapy • Enrollment open • Trial initiation date • Metastases
    |
    HER-2 (Human epidermal growth factor receptor 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Ezharmia (valemetostat)
    almost2years
    A Phase 1/2, Open-label Study of Valemetostat in Combination With Rituximab and Lenalidomide in Relapsed or Refractory Follicular Lymphoma (clinicaltrials.gov)
    P1/2, N=60, Not yet recruiting, M.D. Anderson Cancer Center
    New P1/2 trial • Combination therapy
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    Rituxan (rituximab) • lenalidomide • Ezharmia (valemetostat)
    2years
    Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov)
    P1, N=32, Recruiting, National Cancer Institute (NCI) | Trial completion date: Sep 2027 --> Jul 2028 | Trial primary completion date: Apr 2023 --> Jul 2023
    Trial completion date • Trial primary completion date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    BCL6 rearrangement • BCL2 rearrangement • UGT1A1*1*1 • UGT1A1 mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone • Polivy (polatuzumab vedotin-piiq)
    2years
    Phase 1b Study of EZH1/2 Inhibitor Valemetostat in Combination With Trastuzumab Deruxtecan in Subjects With HER2 Low/Ultra-low/Null Metastatic Breast Cancer (clinicaltrials.gov)
    P1b; N=37; Not yet recruiting; Sponsor:M.D. Anderson Cancer Center
    Combination therapy • New P1 trial
    |
    HER-2 (Human epidermal growth factor receptor 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    PATHWAY antiHer2/neu (4B5) Rabbit Monoclonal Primary Antibody
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Ezharmia (valemetostat)
    2years
    Individualized therapy based on the combination of mini-PDX and NGS for a patient with metastatic AFP-producing and HER-2 amplified gastric cancer. (PubMed, Oncol Lett)
    The mini-PDX model confirmed that the patient's tumor was sensitive to a combination regimen of irinotecan and tegafur-gimeracil-oteracil (S-1)...After six courses of treatment with a regimen comprising 300 mg irinotecan on day 1 + 40 mg S-1 twice daily on days 2-15 + 350 mg trastuzumab once-every 3 weeks, the patient continued with S-1 treatment for 4 courses and trastuzumab for 1 year...Thus, the mini-PDX model combined with the NGS rapidly assessed drug sensitivity in a patient with GC and revealed key genetic mutations. However, the proposed technique requires further research to confirm its potential in the individualized treatment of patients with refractory malignancies.
    Journal • Next-generation sequencing
    |
    HER-2 (Human epidermal growth factor receptor 2) • TP53 (Tumor protein P53) • MSH6 (MutS homolog 6) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    HER-2 amplification • UGT1A1*28 • TP53 Y220C • UGT1A1*1*1 • UGT1A1 mutation
    |
    Herceptin (trastuzumab) • irinotecan • Teysuno (gimeracil/oteracil/tegafur)
    over2years
    IDHENTIFY: An Efficacy and Safety Study of AG-221 (CC-90007) Versus Conventional Care Regimens in Older Subjects With Late Stage Acute Myeloid Leukemia Harboring an Isocitrate Dehydrogenase 2 Mutation (clinicaltrials.gov)
    P3, N=319, Active, not recruiting, Celgene | Trial completion date: Dec 2022 --> Dec 2023
    Trial completion date
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • UGT1A1 mutation
    |
    Abbott RealTime IDH2
    |
    cytarabine • azacitidine • Idhifa (enasidenib) • hydroxyurea
    over2years
    AG-221-C-001: Phase 1/2 Study of Enasidenib (AG-221) in Adults With Advanced Hematologic Malignancies With an Isocitrate Dehydrogenase Isoform 2 (IDH2) Mutation (clinicaltrials.gov)
    P1/2, N=345, Active, not recruiting, Celgene | Trial completion date: Dec 2020 --> Dec 2022
    Trial completion date
    |
    IDH2 (Isocitrate Dehydrogenase (NADP(+)) 2) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    IDH2 mutation • UGT1A1*1*1 • UGT1A1 mutation
    |
    Idhifa (enasidenib)
    over2years
    Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid in Combination With Polatuzumab (ViPOR-P) in Relapsed/Refractory B-cell Lymphoma (clinicaltrials.gov)
    P1, N=32, Recruiting, National Cancer Institute (NCI) | Trial primary completion date: Apr 2022 --> Apr 2023
    Trial primary completion date • Combination therapy
    |
    BCL2 (B-cell CLL/lymphoma 2) • BCL6 (B-cell CLL/lymphoma 6) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    BCL6 rearrangement • BCL2 rearrangement • UGT1A1*1*1 • UGT1A1 mutation
    |
    Venclexta (venetoclax) • Imbruvica (ibrutinib) • lenalidomide • Gazyva (obinutuzumab) • prednisone • Polivy (polatuzumab vedotin-piiq)
    over2years
    Metastasis prone genes in prostate cancer revealed by targeted sequencing (AUA 2022)
    Conclusions : Primary and metastatic prostate cancers contain differently shared genetic aberrations. In metastatic prostate cancer, UGT1A1 , NRG1, and FANCA were distinctively mutated compared with primary prostate cancer, suggesting promising target for metastatic prostate cancer therapy.
    BRCA Biomarker
    |
    TP53 (Tumor protein P53) • BRCA2 (Breast cancer 2, early onset) • PTEN (Phosphatase and tensin homolog) • RB1 (RB Transcriptional Corepressor 1) • NRG1 (Neuregulin 1) • FANCA (FA Complementation Group A) • UGT1A1 (UDP glucuronosyltransferase family 1 member A1) • SPOP (Speckle Type BTB/POZ Protein) • FOXA1 (Forkhead Box A1)
    |
    TP53 mutation • FANCA mutation • NRG1 mutation • UGT1A1*1*1 • UGT1A1 mutation
    almost3years
    A Study of Daratumumab With Pomalidomide, Dexamethasone, and All-Transretinoic Acid in Patients With Multiple Myeloma (clinicaltrials.gov)
    P2, N=43, Recruiting, Hackensack Meridian Health | Trial completion date: Jan 2025 --> Feb 2026
    Trial completion date • Combination therapy
    |
    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    UGT1A1*1*1 • UGT1A1 mutation
    |
    Darzalex (daratumumab) • pomalidomide