^
    12d
    Clinical study of irinotecan liposome combined with fluzoparib in the second-line treatment of recurrent metastatic small cell lung cancer (ChiCTR2400089985)
    P2, N=29, Not yet recruiting, Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine; Renji Hospital affiliated to Shanghai Jiaotong University School of Medi
    New P2 trial • Metastases
    |
    AiRuiYi (fluzoparib)
    12d
    Oxaliplatin combined with Fuzuloparib as third-line therapy in advanced and metastatic pancreatic cancer (P-Opularity/SCOG-P003): A single-arm, exploratory, phase 2 trial. (ChiCTR2400090406)
    P2, N=30, Recruiting, First Affiliated Hospital of Soochow University; First Affiliated Hospital of Soochow University
    New P2 trial • Metastases
    |
    oxaliplatin • AiRuiYi (fluzoparib)
    2ms
    BCTOP-L-M05: SNF Platform Study of HR+/ HER2-advanced Breast Cancer (clinicaltrials.gov)
    P2, N=620, Recruiting, Fudan University | N=140 --> 620
    Enrollment change
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor)
    |
    ER positive • HR positive • HER-2 amplification • HER-2 negative • PGR positive • HER-2 negative + AR positive + ER positive • HER-2 negative + ER positive • HER-2 negative + PGR positive
    |
    Avastin (bevacizumab) • sorafenib • everolimus • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • capecitabine • albumin-bound paclitaxel • fulvestrant • exemestane • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • SHR-A2102 • SHR-A1921 • SHR-A2009
    2ms
    Adebrelimab Combined with Non-platinum Chemotherapy and Fuzuloparib in Recurrent Platinum-resistant Ovarian Cancer (clinicaltrials.gov)
    P2, N=37, Not yet recruiting, Fujian Cancer Hospital
    New P2 trial • IO biomarker
    |
    HRD (Homologous Recombination Deficiency)
    |
    PD-L1 expression • HRD
    |
    albumin-bound paclitaxel • AiRuiYi (fluzoparib) • Ariely (adebrelimab)
    3ms
    abemaSNF1/3: Precision Treatment of HR+ HER2- Advanced Breast Cancer Based on SNF Molecular Subtyping (clinicaltrials.gov)
    P2, N=260, Not yet recruiting, Fudan University
    New P2 trial • Metastases
    |
    everolimus • Verzenio (abemaciclib) • fulvestrant • AiRuiYi (fluzoparib)
    3ms
    A Study of Fluzoparib in Combination With mFOLFIRINOX in Patients With Advanced Pancreatic Cancer (clinicaltrials.gov)
    P1/2, N=39, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed | N=66 --> 39
    Trial completion • Enrollment change • Combination therapy • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    oxaliplatin • irinotecan • AiRuiYi (fluzoparib)
    3ms
    Fluzoparib Combined With Dalpiciclib for Platinum Resistant Recurrent Ovarian Cancer (clinicaltrials.gov)
    P2, N=30, Not yet recruiting, Fudan University
    New P2 trial
    |
    AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    4ms
    Fluzoparib Neoadjuvant Therapy for Ovarian Cancer (clinicaltrials.gov)
    P2, N=48, Recruiting, Qilu Hospital of Shandong University
    New P2 trial • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    AiRuiYi (fluzoparib)
    4ms
    FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov)
    P2, N=716, Recruiting, Fudan University | Phase classification: P1/2 --> P2
    Phase classification
    |
    HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor) • CD8 (cluster of differentiation 8) • FOXC1 (Forkhead Box C1)
    |
    Herceptin (trastuzumab) • carboplatin • Perjeta (pertuzumab) • AiRuiKa (camrelizumab) • AiTan (rivoceranib) • Irene (pyrotinib) • albumin-bound paclitaxel • cyclophosphamide • letrozole • epirubicin • trastuzumab rezetecan (SHR-A1811) • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib) • goserelin acetate • famitinib (SHR 1020) • Ariely (adebrelimab) • SHR-A1921
    4ms
    Fluzoparib in Combination With Apatinib Mesylate for Maintenance Therapy in Stage III-IV Ovarian Cancer (clinicaltrials.gov)
    P3, N=51, Not yet recruiting, Anhui Provincial Hospital
    New P3 trial • Combination therapy
    |
    AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    4ms
    SCRT Followed by Camrelizumab Combined With Fluzoparib and Chemotherapy as Neoadjuvant Therapy for LARC (clinicaltrials.gov)
    P2, N=33, Recruiting, Huazhong University of Science and Technology
    New P2 trial • Metastases
    |
    AiRuiKa (camrelizumab) • capecitabine • oxaliplatin • AiRuiYi (fluzoparib)
    4ms
    Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer (ChiCTR2100046198)
    P2, N=50, Completed, Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center | Recruiting --> Completed
    Trial completion
    |
    abiraterone acetate • AiRuiYi (fluzoparib)
    4ms
    Oxaliplatin or Cisplatin in combination with Fluzoparib as third-line treatment in advanced and metastatic biliary tract cancer (B-OnFire/SCOG-B003): A single-arm, exploratory, phase 2 trial (ChiCTR2400086187)
    P=N/A, N=30, Not yet recruiting, First affiliated hospital of Soochow university; First affiliated hospital of Soochow university
    New trial
    |
    BRCA (Breast cancer early onset)
    |
    cisplatin • oxaliplatin • AiRuiYi (fluzoparib)
    5ms
    Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function (clinicaltrials.gov)
    P1, N=24, Completed, Jiangsu HengRui Medicine Co., Ltd. | Recruiting --> Completed | Trial completion date: Jul 2021 --> Jun 2024 | Trial primary completion date: Jun 2021 --> Jun 2024
    Trial completion • Trial completion date • Trial primary completion date
    |
    AiRuiYi (fluzoparib)
    6ms
    Adebrelimab Plus Chemotherapy, Bevacizumab and Fluzoparib in Platinum-Sensitive Relapsed Ovarian Cancer (clinicaltrials.gov)
    P2, N=22, Not yet recruiting, The First Hospital of Jilin University
    New P2 trial
    |
    Avastin (bevacizumab) • carboplatin • paclitaxel • AiRuiYi (fluzoparib) • Ariely (adebrelimab)
    6ms
    Camrelizumab Plus Fluzoparib for TP-53 Mutated Endometrial Cancer (clinicaltrials.gov)
    P2, N=117, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
    New P2 trial • Metastases
    |
    PD-L1 (Programmed death ligand 1) • HRD (Homologous Recombination Deficiency)
    |
    HRD
    |
    carboplatin • AiRuiKa (camrelizumab) • albumin-bound paclitaxel • AiRuiYi (fluzoparib)
    8ms
    A Study of Maintenance Treatment With Fluzoparib in gBRCA/PALB2 Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (clinicaltrials.gov)
    P3, N=5, Terminated, Jiangsu HengRui Medicine Co., Ltd. | N=136 --> 5 | Recruiting --> Terminated; Sponsor R & D Strategy Adjustment
    Enrollment change • Trial termination • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation • PALB2 mutation
    |
    AiRuiYi (fluzoparib)
    8ms
    A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=306, Recruiting, Risen (Suzhou) Pharma Tech Co., Ltd. | Not yet recruiting --> Recruiting
    Enrollment open • Combination therapy • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • capecitabine • Irene (pyrotinib) • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    9ms
    SYSKY-2023-1016-01: Randomized, Open, Controlled, Multicenter Phase III Clinical Study of Fluzoparib in Combination With Apatinib Versus Investigator-Selected Chemotherapy for HRD-Positive/HER2-negative Advanced Breast Cancer (clinicaltrials.gov)
    P3, N=200, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    New P3 trial • Combination therapy • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    gemcitabine • paclitaxel • AiTan (rivoceranib) • capecitabine • Halaven (eribulin mesylate) • AiRuiYi (fluzoparib) • Navelbine oral (vinorelbine tartrate oral)
    9ms
    Adebrelimab Combined With Fluzoparib in HRD-positive HR +/HER2- Advanced Breast Cancer (clinicaltrials.gov)
    P2, N=40, Not yet recruiting, Zhejiang Cancer Hospital
    New P2 trial • Metastases
    |
    AiRuiYi (fluzoparib) • Ariely (adebrelimab)
    10ms
    Case report of penile squamous cell carcinoma continuous treatment with BRCA2 mutation. (PubMed, World J Surg Oncol)
    This is the first report of penile cancer with BRCA2 mutation, receiving a combination treatment with olaparib and experiencing a benefit for 9 months. This case underscores the pivotal role of BRCA2 in influencing treatment response in PSCC, providing valuable insights into the application of targeted therapies in managing recurrent PSCC with BRCA2 alterations. This elucidation establishes a crucial foundation for further research and clinical considerations in similar cases.
    Journal • Tumor mutational burden • BRCA Biomarker • PARP Biomarker • PD(L)-1 Biomarker • IO biomarker
    |
    TMB (Tumor Mutational Burden) • BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Keytruda (pembrolizumab) • Opdivo (nivolumab) • Lynparza (olaparib) • Yervoy (ipilimumab) • Focus V (anlotinib) • AiRuiYi (fluzoparib)
    10ms
    Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Kidney Function (clinicaltrials.gov)
    P1, N=24, Completed, Jiangsu HengRui Medicine Co., Ltd. | Not yet recruiting --> Completed | Trial completion date: Oct 2022 --> Dec 2023 | Trial primary completion date: Oct 2022 --> Dec 2023
    Trial completion • Trial completion date • Trial primary completion date
    |
    AiRuiYi (fluzoparib)
    10ms
    A Clinical Study of JS105 in Combination With Other Anti-tumor Therapies in Patients With Solid Tumors (clinicaltrials.gov)
    P1/2, N=306, Not yet recruiting, Risen (Suzhou) Pharma Tech Co., Ltd.
    New P1/2 trial • Combination therapy • Metastases
    |
    PIK3CA (Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha)
    |
    PIK3CA mutation
    |
    paclitaxel • Loqtorzi (toripalimab-tpzi) • capecitabine • Irene (pyrotinib) • fulvestrant • AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)
    11ms
    Maintenance Therapy After Platinum-containing Chemotherapy in Patients With Recurrent Ovarian Cancer (clinicaltrials.gov)
    P3, N=37, Not yet recruiting, The First Affiliated Hospital of Xiamen University
    New P3 trial
    |
    AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    11ms
    Advances in Development of Selective Antitumor Inhibitors That Target PARP-1. (PubMed, J Med Chem)
    The currently approved PARP inhibitors include olaparib, niraparib, rucaparib, talazoparib, fuzuloparib, and pamiparib. The present review introduces the necessity for research on the development of selective PARP-1 inhibitors from the perspective of structural and functional mechanisms of PARP-1 inhibition. A review of recently reported selective PARP-1 inhibitors provides the foundation for exploring novel strategies for designing selective PARP-1 inhibitors from the perspective of structure-activity relationships combined with computer simulations.
    Review • Journal
    |
    PARP2 (Poly(ADP-Ribose) Polymerase 2)
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib) • Rubraca (rucaparib) • Partruvix (pamiparib) • AiRuiYi (fluzoparib)
    12ms
    Fluzoparib and Abiraterone in the preSurgery Treatment of Prostate Cancer: FAST Trial (clinicaltrials.gov)
    P2, N=34, Active, not recruiting, Fudan University | Recruiting --> Active, not recruiting | Trial completion date: May 2023 --> Dec 2023
    Enrollment closed • Trial completion date
    |
    abiraterone acetate • prednisone • AiRuiYi (fluzoparib)
    12ms
    Fluzoparib With or Without Apatinib in Platinum-sensitive Relapsed Ovarian Cancer Previously Treated With PARPi (clinicaltrials.gov)
    P2, N=80, Not yet recruiting, Guangxi Medical University
    New P2 trial
    |
    AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    12ms
    A multicenter, open-label, phase II clinical study of the safety and efficacy of fluzoparib in combination with apatinib in platinum-sensitive advanced ovarian cancer that has progressed after previous PARP inhibitor therapy (ChiCTR2300074862)
    P4, N=30, Recruiting, Shandong Provincial Hospital; Shandong Provincial Hospital
    New P4 trial
    |
    MUC16 (Mucin 16, Cell Surface Associated)
    |
    AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    1year
    Efficacy and Safety of Fluzoparib Combined With Adjuvant Endocrine Therapy for HR+/HER2- SNF3-subtype Early Breast Cancer (clinicaltrials.gov)
    P3, N=766, Recruiting, Fudan University | Not yet recruiting --> Recruiting
    Enrollment open
    |
    HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
    |
    HER-2 negative
    |
    tamoxifen • Verzenio (abemaciclib) • letrozole • anastrozole • exemestane • AiRuiYi (fluzoparib) • goserelin acetate
    1year
    Development and validation of a sensitive LC-MS/MS method for the assay of four PARP inhibitors in human plasma and its application in ovarian cancer patients. (PubMed, J Pharm Biomed Anal)
    In this study, we established and validated a liquid chromatography-tandem mass spectrometry (LC-MS/MS) based method to simultaneously quantify the four frequently prescripted PARP inhibitors, namely niraparib, olaparib，fluzoparib, and pamiparib, in ovarian cancer. The mean plasma concentrations (±SD) of niraparib and olaparib were 424.76 (±228.35) ng/mL and 1760.47 (±1739.69) ng/mL, respectively. The validated LC-MS/MS method allows the convient and efficient determination of four PARP inhibitors' exposure levels in ovarian cancer patients.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    Lynparza (olaparib) • Zejula (niraparib) • Partruvix (pamiparib) • AiRuiYi (fluzoparib)
    1year
    PARP inhibitors: A review of the pharmacology, pharmacokinetics, and pharmacogenetics. (PubMed, Semin Oncol)
    Currently, four agents, namely olaparib, rucaparib, niraparib, and talazoparib, have obtained approval in the United States and Europe. Additionally, this review briefly covers veliparib, a PARP inhibitor under development, and two recently approved PARP inhibitors in China, fuzuloparib and pamiparib. Although significant progress has been made in understanding PARP inhibitors, there are several unanswered questions that remain, necessitating further research across a broader spectrum of cancer types within this evolving class of anticancer agents.
    PK/PD data • Review • Journal • PARP Biomarker
    |
    PARP2 (Poly(ADP-Ribose) Polymerase 2)
    |
    Lynparza (olaparib) • Talzenna (talazoparib) • Zejula (niraparib) • Rubraca (rucaparib) • veliparib (ABT-888) • Partruvix (pamiparib) • AiRuiYi (fluzoparib)
    1year
    AN PROSPECTIVE; SINGLE-ARM; PHASE Ⅱ STUDY OF ALTERNATING REGIMENS OF FLUZOPARIB AND ORAL ETOPOSIDE MAINTENANCE THERAPY; IN NEWLY DIAGNOSED ADVANCED OVARIAN CANCER: FARE TRIAL (IGCS 2023)
    A current therapy option for advanced OC patients is debulking surgery; followed by platinum-based chemotherapy ± bevacizumab; followed by maintenance therapy with bevacizumab or monotherapy with PARP inhibitors. Primary endpoint is progressionfree survival (PFS). Current Trial Status: Trial in progress: there are no available results at the time of submission, and there are no available conclusions at the time of submission.
    Clinical • BRCA Biomarker • PARP Biomarker • Metastases
    |
    HRD (Homologous Recombination Deficiency) • BRCA (Breast cancer early onset)
    |
    HRD • BRCA mutation
    |
    Avastin (bevacizumab) • etoposide oral • AiRuiYi (fluzoparib)
    1year
    Adebrelimab Combined With Fuzuloparib in the Treatment of Patients With Recurrent Platinum-resistant Ovarian Cancer. (clinicaltrials.gov)
    P2, N=37, Recruiting, Fujian Cancer Hospital | Not yet recruiting --> Recruiting | Initiation date: May 2023 --> Aug 2023
    Enrollment open • Trial initiation date
    |
    HRD (Homologous Recombination Deficiency)
    |
    AiRuiYi (fluzoparib) • Ariely (adebrelimab)
    1year
    PARP Inhibition, Stereotactic Body Radiotherapy and Immunotherapy for Metastatic or Advanced Sarcoma (PRIMA): a Prospective Phase 2 Trial (clinicaltrials.gov)
    P2, N=86, Recruiting, Ruijin Hospital
    New P2 trial • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    AiRuiKa (camrelizumab) • AiRuiYi (fluzoparib)
    1year
    A phase 1 trial of fuzuloparib in combination with apatinib for advanced ovarian and triple-negative breast cancer: efficacy, safety, pharmacokinetics and germline BRCA mutation analysis. (PubMed, BMC Med)
    Fuzuloparib plus apatinib had acceptable safety in patients with advanced OC or TNBC. Fuzuloparib 100 mg bid plus apatinib 500 mg qd was established as the RP2D. With the promising clinical activity observed, this combination is warranted to be further explored as a potential alternative to chemotherapy.
    P1 data • PK/PD data • Journal • Combination therapy • BRCA Biomarker • PARP Biomarker • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    BRCA mutation
    |
    AiTan (rivoceranib) • AiRuiYi (fluzoparib)
    1year
    First-line Maintenance Treatment With Fluzoparib Plus Bevacizumab in Advanced BRCA Wild Type Ovarian Cancer (clinicaltrials.gov)
    P2, N=44, Not yet recruiting, Sun Yat-sen University
    New P2 trial • Combination therapy • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    BRCA wild-type
    |
    Avastin (bevacizumab) • AiRuiYi (fluzoparib)
    1year
    A Clinical Study of Chemoradiotherapy Sequential Fluzoparib in Pan-solid Tumors (clinicaltrials.gov)
    P2, N=120, Not yet recruiting, Chongqing University Cancer Hospital
    New P2 trial
    |
    EGFR (Epidermal growth factor receptor) • ALK (Anaplastic lymphoma kinase) • ROS1 (Proto-Oncogene Tyrosine-Protein Kinase ROS)
    |
    EGFR mutation • ALK mutation • ROS1 mutation
    |
    AiRuiKa (camrelizumab) • capecitabine • AiRuiYi (fluzoparib)
    1year
    Enhanced efficacy of combined fluzoparib and chidamide targeting in natural killer/T-cell lymphoma. (PubMed, Ann Hematol)
    In vivo, this combined regimen also showed synergistic antitumor effects in xenograft mouse models. The combination of fluzoparib and chidamide showed synergistic effects against NKTCL both in vitro and in vivo and deserves further exploration in clinical trials.
    Journal • BRCA Biomarker • PARP Biomarker
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset) • RAD51 (RAD51 Homolog A)
    |
    BRCA2 mutation • BRCA1 mutation
    |
    Epidaza (chidamide) • AiRuiYi (fluzoparib)
    over1year
    Efficacy and safety of fluzoparib combined with anlotinib in extensive stage small cell lung cancer after first-line platinum-based chemotherapy: a multi-center, single-arm prospective phase II clinical study (STAMP study). (PubMed, BMC Cancer)
    The addition of fluzoparib to anlotinib is expected to increase the clinical benefit in ES-SCLC patients after platinum-based chemotherapy.
    P2 data • Journal
    |
    KIT (KIT proto-oncogene, receptor tyrosine kinase) • FGFR (Fibroblast Growth Factor Receptor) • PARP2 (Poly(ADP-Ribose) Polymerase 2) • PARP3 (Poly(ADP-Ribose) Polymerase Family Member 3)
    |
    Avastin (bevacizumab) • sorafenib • Focus V (anlotinib) • thalidomide • AiRuiYi (fluzoparib)
    over1year
    Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, Peking University Cancer Hospital & Institute
    New P1/2 trial • Combination therapy • Metastases
    |
    SF3B1 (Splicing Factor 3b Subunit 1)
    |
    SF3B1 mutation
    |
    temozolomide • AiRuiKa (camrelizumab) • AiRuiYi (fluzoparib)
    over1year
    A Study of Fluzoparib Combined With QL1101 Maintenance Treatment in Patients With Advanced Ovarian Cancer Following Response on Front-Line Platinum-Based Chemotherapy (clinicaltrials.gov)
    P2, N=25, Recruiting, Yongpeng Wang | Not yet recruiting --> Recruiting | Initiation date: Oct 2022 --> Jul 2023
    Enrollment open • Trial initiation date • Metastases
    |
    BRCA1 (Breast cancer 1, early onset) • BRCA2 (Breast cancer 2, early onset)
    |
    AiRuiYi (fluzoparib) • Ankeda (bevacizumab biosimilar)
    over1year
    Phase Ib/II Study of Fluzoparib in Combination With Dalpiciclib in Patients With Locally Advanced or Metastatic Sarcoma (clinicaltrials.gov)
    P2, N=50, Recruiting, Sun Yat-sen University
    New P2 trial • Combination therapy • Metastases
    |
    BRCA (Breast cancer early onset)
    |
    AiRuiYi (fluzoparib) • AiRuiKang (dalpiciclib)