^
    5d
    Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination With XELOX or Irinotecan in Patients With Advanced Gastric Cancer (clinicaltrials.gov)
    P1/2, N=87, Active, not recruiting, Idience Co., Ltd. | Recruiting --> Active, not recruiting | Trial completion date: Jun 2026 --> Mar 2027 | Trial primary completion date: Sep 2025 --> Jul 2026
    Enrollment closed • Trial completion date • Trial primary completion date
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    UGT1A1 (UDP glucuronosyltransferase family 1 member A1)
    |
    capecitabine • oxaliplatin • irinotecan • venadaparib (NOV 1401)
    4ms
    A Phase IIb Randomized Clinical Trial of Immune Checkpoint Inhibitor-based Maintenance Therapy in Patients With Advanced Biliary Tract Cancer (clinicaltrials.gov)
    P1/2, N=160, Not yet recruiting, Yonsei University
    New P1/2 trial • Checkpoint inhibition
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    Keytruda (pembrolizumab) • Imfinzi (durvalumab) • venadaparib (NOV 1401)
    1year
    First-In-Human Dose Finding Study of Venadaparib (IDX-1197), a Potent and Selective PARP Inhibitor, in Patients With Advanced Solid Tumors. (PubMed, Cancer Med)
    Further studies are warranted to explore efficacy and safety of venadaparib in other tumor types and in combination with various agents, as well as to explore relevant biomarkers. (ClinicalTrials.gov ID: NCT03317743).
    P1 data • Journal • BRCA Biomarker • PARP Biomarker
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    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    BRCA mutation
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    venadaparib (NOV 1401)
    over1year
    The Synergistic Effect of PARP Inhibitors and Irinotecan in Small Cell Lung Cancer Cells. (PubMed, Cancer Res Treat)
    When treated with 50 nM irinotecan, the IC50 fold changes for PARP inhibitors were: olaparib, 1649 ± 4049; talazoparib, 25 ± 34.21; venadaparib, 336 ± 596.01. This study provides preclinical evidence of the potential clinical benefits of combining irinotecan with PARP inhibitors in SCLC. Further clinical investigations are warranted to validate these findings for the development of more effective and personalized therapeutic strategies for SCLC patients.
    Journal • BRCA Biomarker • PARP Biomarker
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    BRCA (Breast cancer early onset) • CHEK1 (Checkpoint kinase 1)
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    BRCA mutation
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    Lynparza (olaparib) • Talzenna (talazoparib) • irinotecan • venadaparib (NOV 1401)
    over1year
    Basket Trial of IDX-1197, a PARP Inhibitor, in Patients with HRR Mutated Solid Tumors (VASTUS) (clinicaltrials.gov)
    P1/2, N=108, Completed, Idience Co., Ltd. | Active, not recruiting --> Completed | Phase classification: P1b/2a --> P1/2 | N=310 --> 108 | Trial completion date: Dec 2023 --> Jun 2024
    Trial completion • Phase classification • Enrollment change • Trial completion date • Pan tumor
    |
    venadaparib (NOV 1401)
    over1year
    Study to Assess the Safety, Tolerability, and Efficacy of IDX-1197 in Combination with XELOX or Irinotecan in Patients with Advanced Gastric Cancer (clinicaltrials.gov)
    P1/2, N=100, Recruiting, Idience Co., Ltd. | Phase classification: P1b --> P1/2 | Trial completion date: Mar 2024 --> Jun 2026 | Trial primary completion date: Sep 2023 --> Sep 2025
    Phase classification • Trial completion date • Trial primary completion date • Combination therapy • Metastases
    |
    capecitabine • oxaliplatin • irinotecan • venadaparib (NOV 1401)
    almost2years
    Novel anti-Acanthamoeba effects elicited by a repurposed poly (ADP-ribose) polymerase inhibitor AZ9482. (PubMed, Front Cell Infect Microbiol)
    Using a homology model of Acanthamoeba poly (ADP-ribose) polymerases (PARPs), molecular docking of approved drugs revealed three potential inhibitory compounds: olaparib, venadaparib and AZ9482. Analyzing gene expression related to DNA damage repair pathway and the rate of apurinic/apyrimidinic (AP) sites indicated DNA damage efficacy and repair modulation in Acanthamoeba trophozoites following AZ9482 treatment. Collectively, these findings highlight AZ9482, as a structurally unique PARP inhibitor, provides a promising prototype for advancing anti-Acanthamoeba drug research.
    Journal • PARP Biomarker
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    ANXA5 (Annexin A5)
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    Lynparza (olaparib) • venadaparib (NOV 1401)
    almost2years
    Association between homologous recombination deficiency (HRD) gene mutations and the efficacy of venadaparib in combination with irinotecan as third- or fourth-line treatment in patients with metastatic gastric cancer (mGC). (ASCO 2024)
    Venadaparib in combination with irinotecan showed promising efficacy outcomes in patients with mGC, especially for those with mutations of HRD-related genes. Further development of this combination may consider a biomarker-based approach. Clinical trial information: NCT04725994.
    Combination therapy • Clinical • PARP Biomarker • BRCA Biomarker • Metastases
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • PALB2 (Partner and localizer of BRCA2) • CHEK2 (Checkpoint kinase 2) • RAD51 (RAD51 Homolog A) • RAD51B (RAD51 Paralog B) • ATR (Ataxia telangiectasia and Rad3-related protein) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • POLD1 (DNA Polymerase Delta 1) • CHEK1 (Checkpoint kinase 1) • BARD1 (BRCA1 Associated RING Domain 1)
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    GuardantOMNI
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    irinotecan • venadaparib (NOV 1401)
    over2years
    Predictive role of homologous recombination deficiency (HRD) for irinotecan in combination with venadaparib, a novel PARP1/2 inhibitor, as third- or fourth-line treatment in patients with advanced gastric cancer. (ASCO-GI 2024)
    P1b | "Venadaparib in combination with irinotecan showed synergistic effect in vitro assays and promising clinical efficacy in the systemic treatment of refractory GC, particularly in patients with HRD. The dose expansion phase of the study is ongoing to investigate the optimal biological dose and patient selection strategies, in a randomized design. Clinical trial information: NCT04725994."
    Combination therapy • Clinical
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    GuardantOMNI
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    irinotecan • venadaparib (NOV 1401)
    almost3years
    Co-mutation of ATM and ASXL1 and relationship to durable response of a novel PARP1/2 inhibitor, venadaparib, in patients with pancreatic cancer. (ASCO 2023)
    In this exploratory analysis, patients with co-occurring ATMm and ASXL1m showed higher tumor response. This signals potential value from ATM and ASXL1 co-mutation predicting efficacy of Venadaparib in PC and warrants further validation. Clinical trial information: NCT04174716.
    Clinical • PARP Biomarker • BRCA Biomarker
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    ATM (ATM serine/threonine kinase) • HRD (Homologous Recombination Deficiency) • ASXL1 (ASXL Transcriptional Regulator 1) • BRCA (Breast cancer early onset)
    |
    ATM mutation • ASXL1 mutation • BRCA mutation • ASXL1 mutation + ATM mutation
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    GuardantOMNI
    |
    venadaparib (NOV 1401)
    3years
    Venadaparib Is a Novel and Selective PARP Inhibitor with Improved Physicochemical Properties, Efficacy, and Safety. (PubMed, Mol Cancer Ther)
    Venadaparib had wider safety margins than olaparib. Our results suggest the possibility of venadaparib as a next-generation PARP inhibitor. On the basis of these findings, phase Ib/IIa studies on the efficacy and safety of venadaparib have been initiated.
    Journal • BRCA Biomarker • PARP Biomarker
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    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    BRCA mutation
    |
    Lynparza (olaparib) • venadaparib (NOV 1401)
    3years
    Venadaparib is a novel and selective PARP inhibitor with improved physicochemical properties, efficacy, and safety. (PubMed, Mol Cancer Ther)
    Venadaparib had wider safety margins than olaparib. Our results suggest the possibility of venadaparib as a next generation PARP inhibitor. Based on these findings, phase 1b/2a studies on the efficacy and safety of venadaparib have been initiated.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    BRCA mutation
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    Lynparza (olaparib) • venadaparib (NOV 1401)