^
    22d
    Fluzoparib in Combination With or Without Camrelizumab for Homologous Recombinant Deficiency (HRD) HER2 Negative Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=80, Suspended, wang shusen | Trial completion date: Dec 2026 --> Dec 2027 | Recruiting --> Suspended | Trial primary completion date: Mar 2025 --> Mar 2026
    Trial completion date • Trial suspension • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2)
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    HER-2 negative
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    AiRuiKa (camrelizumab) • AiRuiYi (fluzoparib)
    1m
    Neoadjuvant Treatment of Ovarian Cancer With Fuzuloparib in Combination With Apatinib (clinicaltrials.gov)
    P2, N=48, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Not yet recruiting --> Recruiting
    Enrollment open
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    HRD (Homologous Recombination Deficiency)
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    HRD
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    carboplatin • paclitaxel • AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    1m
    A Study on the Use of Fluzoparib Combined With Chemotherapy for Neoadjuvant Treatment of HRD-positive, HR+/HER2- Breast Cancer (clinicaltrials.gov)
    P2, N=28, Recruiting, Xijing Hospital | Trial completion date: Dec 2025 --> Dec 2026 | Trial primary completion date: Nov 2025 --> Nov 2026
    Trial completion date • Trial primary completion date
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    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
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    BRCA2 mutation • ER positive • BRCA1 mutation • HER-2 negative • HRD • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive
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    docetaxel • cyclophosphamide • AiRuiYi (fluzoparib)
    3ms
    A Randomized, Open-label, Double-cohort Study of Fluzoparib Combined With Famitinib Malate or SHR-1701 for Neoadjuvant Therapy in Patients With Advanced Ovarian Cancer (clinicaltrials.gov)
    P2, N=104, Not yet recruiting, Qinglei Gao
    New P2 trial
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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    AiRuiYi (fluzoparib) • retlirafusp alfa (SHR-1701) • famitinib (SHR 1020)
    3ms
    Fluzoparib as Adjuvant Treatment in Patients With Germline Homologous Recombination Repair (HRR) Mutated Primary Breast Cancer (Flamenco) (clinicaltrials.gov)
    P2, N=334, Not yet recruiting, Fudan University
    New P2 trial • IO biomarker
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    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • RAD51 (RAD51 Homolog A) • RAD51B (RAD51 Paralog B) • BRIP1 (BRCA1 Interacting Protein C-terminal Helicase 1) • RAD51C (RAD51 paralog C) • RAD50 (RAD50 Double Strand Break Repair Protein) • PARP1 (Poly(ADP-Ribose) Polymerase 1) • RAD51D (RAD51 paralog D) • BARD1 (BRCA1 Associated RING Domain 1) • NBN (Nibrin Nijmegen Breakage Syndrome 1 (Nibrin)) • RAD54L (DNA Repair And Recombination Protein RAD54) • FANCM (FA Complementation Group M) • RAD52 (RAD52 Homolog DNA Repair Protein) • RPA1 (Replication Protein A1) • PARP2 (Poly(ADP-Ribose) Polymerase 2)
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    HER-2 negative • PALB2 mutation • PGR positive • BRIP1 mutation • RAD51C mutation • RAD51D mutation • RAD51B mutation • BARD1 mutation • RAD54L mutation
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    capecitabine • AiRuiYi (fluzoparib)
    3ms
    Clinical Study of EZH2 Inhibitor Combined With PARP Inhibitor in the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Peking University Third Hospital
    New P2 trial • Platinum sensitive
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
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    BRCA wild-type
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    AiRuiYi (fluzoparib) • zeprumetostat (SHR-2554)
    3ms
    Fzp-MA-TNBC: A Single-Arm Phase Ⅱ Study of Fluzoparib Maintenance in Platinum-sensitive Advanced Triple-Negative Breast Cance (clinicaltrials.gov)
    P2, N=72, Not yet recruiting, Tianjin Medical University Cancer Institute and Hospital
    New P2 trial • Platinum sensitive
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    HER-2 (Human epidermal growth factor receptor 2) • BRCA (Breast cancer early onset)
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    HER-2 negative
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    AiRuiYi (fluzoparib)
    3ms
    Efficacy and safety of PARP inhibitors in metastatic breast cancer patients with homologous recombination repair pathway gene mutations: a retrospective multicenter real-world study. (PubMed, Ther Adv Med Oncol)
    In total, 62 MBC patients treated with olaparib (N = 55), talazoparib (N = 4), pamiparib (N = 2), and fluzoparib (N = 1) were enrolled. Hematologic toxicity was the most common grade ⩾3 AEs. PARPis showed promising PFS and tolerable toxicity in the real-world treatment of Chinese MBC patients with HRR-related gene mutations.
    Retrospective data • Journal • Real-world evidence • BRCA Biomarker • PARP Biomarker
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    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • HRD (Homologous Recombination Deficiency)
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    Lynparza (olaparib) • Talzenna (talazoparib) • Partruvix (pamiparib) • AiRuiYi (fluzoparib)
    3ms
    The cytoskeletal protein smoothelin maintains homologous recombination repair by stabilizing RAD51 in an HUWE1-dependent manner in colorectal cancer. (PubMed, Acta Pharm Sin B)
    To explore the therapeutic role of SMTN, customized cell membrane infused biomimetic liposomes were constructed to ensure rapid delivery of SMTN siRNA specifically into HCT-116 cells, yielding significantly enhanced anti-cancer effects of irinotecan and fuzuloparib both in vitro and in vivo. To summarize, our findings revealed a novel function of SMTN in DNA damage repair and provided a therapeutic strategy of targeting SMTN to enhance the efficacy of DNA damage agents.
    Journal
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    HRD (Homologous Recombination Deficiency) • RAD51 (RAD51 Homolog A) • HUWE1 (HECT UBA And WWE Domain Containing E3 Ubiquitin Protein Ligase 1) • SMTN (Smoothelin)
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    irinotecan • AiRuiYi (fluzoparib)
    4ms
    Preoperative Moderately Fractionated IMRT for Locally Extremity or Trunk Sarcoma (SPARE-03) (clinicaltrials.gov)
    P2, N=52, Completed, Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting --> Completed | N=100 --> 52 | Trial completion date: Dec 2026 --> Dec 2024 | Trial primary completion date: Apr 2026 --> Dec 2024
    Trial completion • Enrollment change • Trial completion date • Trial primary completion date
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    AiRuiYi (fluzoparib)