Clinical Trials

Numerous clinical trials across various phases are evaluating fluzoparib in diverse indications, including relapsed ovarian cancer, HER2-negative breast cancer, HRD-altered metastatic colorectal cancer, extensive-stage small cell lung cancer, soft tissue or bone sarcomas, and organ impairment pharmacokinetics. Sponsored by pharmaceutical entities such as Jiangsu HengRui Medicine Co. Ltd. alongside academic institutions including Fudan University and Ruijin Hospital, recruitment statuses range from completed and actively recruiting to not yet recruiting, suspended, or unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07353437 NOT_YET_RECRUITING
Breast Cancer
Fudan University
 2026-03-31 PHASE2
NCT06255392 RECRUITING
Fludzoparib" and Anti-angiogenic; HRD-positive/HER2-negative Advanced Breast Cancer
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
 2024-06-12 PHASE3
NCT07647653 NOT_YET_RECRUITING
Ovarian Cancer
Shandong University
 2026-06-30 PHASE2
NCT07382713 NOT_YET_RECRUITING
Ovarian Cancer
Jinhua Zhou
 2026-02-28 PHASE2
NCT07141771 NOT_YET_RECRUITING
SCLC, Extensive Stage
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2025-12-31 PHASE1; PHASE2
NCT06954584 RECRUITING
Ovarian Cancer
Tongji Hospital
 2025-05-27 PHASE3
NCT05894018 RECRUITING
Sarcoma,Soft Tissue; Brachytherapy; Poly(ADP-ribose) Polymerase Inhibitors
Fujun Zhang
 2023-06-29 PHASE2
NCT07355010 NOT_YET_RECRUITING
Ovarian Cancer
Qinglei Gao
 2025-12-30 PHASE2
NCT07752550 NOT_YET_RECRUITING
Triple-Negative Breast Cancer (TNBC)
Harbin Medical University
 2026-07-30 PHASE2
NCT05891093 RECRUITING
Breast Cancer
Fudan University
 2023-06-01 PHASE3
NCT05582499 RECRUITING
Breast Neoplasm; Breast Cancer; Breast Tumors; Triple-Negative Breast Cancer (TNBC); HER2-positive Breast Cancer; HER2-negative Breast Cancer; Hormone Receptor Positive Tumor; Hormone Receptor Negative Tumor; Early-stage Breast Cancer; Locally Advanced Breast Cancer
Fudan University
 2022-11-01 PHASE2
NCT07321015 RECRUITING
Platinum-sensitive; TNBC, Triple Negative Breast Cancer; BRCA1/2 Mutation or Not
Tianjin Medical University Cancer Institute and Hospital
 2026-01-20 PHASE2
NCT06971211 RECRUITING
Metastatic Castration-resistant Prostate Cancer
Jianbin Bi
 2024-11-27 PHASE2
NCT06612814 ACTIVE_NOT_RECRUITING
Breast Cancer Metastatic
Zhimin Shao
 2024-09-01 PHASE3
NCT05576389 RECRUITING
Germline BRCA-mutated HER2-negative Breast Cancer
Peking University People's Hospital
 2022-10-01 PHASE2
NCT06827717 RECRUITING
Ewing Sarcoma
Sun Yat-sen University
 2025-04-15 PHASE2
NCT06208410 RECRUITING
Advanced Solid Tumors
Risen (Suzhou) Pharma Tech Co., Ltd.
 2024-01-11 PHASE1; PHASE2
NCT05983237 RECRUITING
Melanoma
Jun Guo
 2023-08-15 PHASE1; PHASE2
NCT06913777 RECRUITING
Neoadjuvant Therapy
Fudan University
 2025-04-08 PHASE3
NCT06254066 NOT_YET_RECRUITING
Female Breast Cancer Patients; Histopathologically Confirmed Advanced HR +/HER2-invasive Breast Cancer; HRD Positive Advanced Breast Cancer
Zhejiang Cancer Hospital
 2024-04-16 PHASE2
NCT06552858 NOT_YET_RECRUITING
Ovarian Cancer
Fudan University
 2024-09-01 PHASE2
NCT06074692 RECRUITING
Sarcoma; Sarcoma,Soft Tissue; Sarcoma of Bone
Ruijin Hospital
 2023-06-01 PHASE2
NCT06735326 RECRUITING
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer
Qilu Hospital of Shandong University
 2024-11-27 PHASE2
NCT07047066 NOT_YET_RECRUITING
Glioblastoma
Tongji Hospital
 2025-07-10 PHASE2
NCT06413992 RECRUITING
Endometrial Carcinoma; TP53 Mutation; Recurrent or Metastatic
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2024-05-10 PHASE2
NCT06446206 NOT_YET_RECRUITING
Platinum-sensitive Relapsed Ovarian Cancer
The First Hospital of Jilin University
 2024-06 PHASE2
NCT06541314 UNKNOWN
Ovarian Cancer
Qilu Hospital of Shandong University
 2024-06-18 PHASE2
NCT05656131 SUSPENDED
Advanced HER2 Negative Breast Carcinoma HRD+Breast Cancer
wang shusen
 2022-11-23 PHASE2
NCT07000344 TERMINATED
Ovarian Cancer
Peking Union Medical College Hospital
 2025-07-01
NCT07162051 COMPLETED
HR+/HER2- Early Breast Cancer
Xijing Hospital
 2023-03-03 PHASE2
NCT06561022 UNKNOWN
Breast Cancer
Fudan University
 2024-08-21 PHASE2
NCT05594095 RECRUITING
Breast Neoplasm; Breast Cancer; Hormone Receptor Positive Tumor; HER2-negative Breast Cancer; Advanced Breast Cancer
Fudan University
 2022-12-30 PHASE2
NCT06188455 NOT_YET_RECRUITING
Ovarian Cancer
The First Affiliated Hospital of Xiamen University
 2024-12-01 PHASE3
NCT05585281 UNKNOWN
Ovarian Cancer
Yongpeng Wang
 2023-07-27 PHASE2
NCT05759546 RECRUITING
Breast Cancer Metastatic
Fudan University
 2023-02-01 PHASE2
NCT06539091 NOT_YET_RECRUITING
Epithelial Ovarian Cancer; Efficacy; Safety; Bone Mineral Density; Tolerability
Anhui Provincial Hospital
 2024-10-01 PHASE3
NCT06516445 UNKNOWN
Colorectal Cancer
Huazhong University of Science and Technology
 2023-06-28 PHASE2
NCT05834582 UNKNOWN
TNBC - Triple-Negative Breast Cancer
The First Affiliated Hospital with Nanjing Medical University
 2023-04-08 PHASE2
NCT06161272 UNKNOWN
Ovarian Cancer; High Grade Serous Adenocarcinoma of Ovary; Primary Peritoneal Carcinoma; Fallopian Tube Cancer
Guangxi Medical University
 2023-12-10 PHASE2
NCT06063070 NOT_YET_RECRUITING
Ovarian Cancer; High Grade Serous Adenocarcinoma of Ovary; High Grade Endometrioid Ovarian Cancer; Primary Peritoneal Cancer; Fallopian-tube Cancer
Sun Yat-sen University
 2023-10-18 PHASE2
NCT05938374 COMPLETED
Soft Tissue Sarcoma
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
 2023-05-01 PHASE2
NCT04978012 UNKNOWN
Nasopharyngeal Carcinoma; Nasopharyngeal Cancer
Fudan University
 2021-07-25 PHASE2
NCT06081595 NOT_YET_RECRUITING
Relapsed Ovarian Cancer
Jin Li
 2023-10-30 PHASE2
NCT04937972 UNKNOWN
Non-Small Cell Lung Cancer
Hunan Province Tumor Hospital
 2021-07-01 PHASE2
NCT05952128 UNKNOWN
Sarcoma
Sun Yat-sen University
 2023-07-01 PHASE2
NCT05349409 UNKNOWN
Advanced Solid Tumors
Suzhou Suncadia Biopharmaceuticals Co., Ltd.
 2022-06-09 PHASE2
NCT06055166 UNKNOWN
PARP Inhibitor for Esophageal Squamous Cell Carcinoma
Chongqing University Cancer Hospital
 2023-11-01 PHASE2
NCT05551208 RECRUITING
Ovarian Cancer
Chongqing University Cancer Hospital
 2022-08-15 PHASE2
NCT05932264 UNKNOWN
NSCLC; Non-small Cell Lung Cancer
Sun Yat-sen University
 2023-07 PHASE2
NCT05761470 RECRUITING
Her-2 Negative Breast Cancer; HRR Gene Mutation
Ying Lin
 2022-05-06 PHASE2
NCT05170594 UNKNOWN
Ovarian Cancer
The Second Affiliated Hospital of Shandong First Medical University
 2021-12-24 PHASE2
NCT04694365 COMPLETED
Hepatic Impairment; Healthy Subjects
Jiangsu HengRui Medicine Co., Ltd.
 2021-03-01 PHASE1
NCT05928780 UNKNOWN
TNBC - Triple-Negative Breast Cancer
Fudan University
 2023-07-01 PHASE1; PHASE2
NCT05032235 COMPLETED
Renal Impairment
Jiangsu HengRui Medicine Co., Ltd.
 2021-11-09 PHASE1
NCT05223582 UNKNOWN
High-risk Prostate Cancer; Neoadjuvant Therapy
Fudan University
 2021-05-01 PHASE2
NCT04517357 COMPLETED
Relapsed Ovarian Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2020-10-16 PHASE2
NCT05732129 UNKNOWN
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer
Fudan University
 2023-03-01 PHASE2
NCT05479487 UNKNOWN
Relapsed Ovarian Cancer
Xiaohua Wu MD
 2022-08-01 PHASE2
NCT05085626 UNKNOWN
Advanced HER2 Negative Breast Carcinoma; HRD+Breast Cancer
Tianjin Medical University Cancer Institute and Hospital
 2021-02-08 PHASE2
NCT04229615 UNKNOWN
Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Carcinoma
Jiangsu HengRui Medicine Co., Ltd.
 2020-06-02 PHASE3
NCT04535687 COMPLETED
Renal Cell Carcinoma
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
 2020-12-17 PHASE2
NCT04108247 UNKNOWN
Prostate Cancer Castration-resistant Prostate Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-09-26 PHASE1
NCT04782089 UNKNOWN
Small Cell Lung Cancer
Qilu Hospital of Shandong University
 2021-05-06
NCT04355858 UNKNOWN
Breast Cancer; Metastatic Cancer
Fudan University
 2020-05-01 PHASE2
NCT04425876 UNKNOWN
Pancreatic Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2020-12-17 PHASE1
NCT04828395 UNKNOWN
Non-small Cell Lung Cancer
Tianjin Medical University Cancer Institute and Hospital
 2021-03-01 PHASE2
NCT05732129 Not yet recruiting
Homologous Recombination Deficiency Alterations Metastatic Colorectal Cancer
Fudan University
 2023-03-01 Phase 2
NCT04869488 COMPLETED
Metastatic Castration Resistant Prostate Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2021-07-19 PHASE2
NCT04718740 COMPLETED
Recurrent Ovarian Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2021-06-25 PHASE1
NCT04228601 COMPLETED
Advanced Pancreatic Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2020-01-21 PHASE1; PHASE2
NCT04296370 UNKNOWN
Treatment in HER2-negative Metastatic Breast Cancer Patients With Germline BRCA Mutation
Jiangsu HengRui Medicine Co., Ltd.
 2020-07-13 PHASE3
NCT04300114 TERMINATED
Metastatic Pancreatic Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2020-08-19 PHASE3
NCT04400188 COMPLETED
Small Cell Lung Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2020-06-11 PHASE1; PHASE2
NCT03863860 COMPLETED
Ovarian Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-04-30 PHASE3
NCT05032235 Completed
Renal Impairment
Jiangsu HengRui Medicine Co. Ltd.
 2021-11-09 Phase 1
NCT04102124 TERMINATED
Prostate Cancer; Castration-resistant Prostate Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-04-08 PHASE2
NCT03075462 COMPLETED
Ovarian Cancer; Triple Negative Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2017-03-09 PHASE1
NCT04659785 UNKNOWN
Small Cell Lung Cancer Extensive Stage
Tianjin Medical University Second Hospital
 2020-07-01 PHASE1; PHASE2
NCT04041011 COMPLETED
Small Cell Lung Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-09-17 PHASE1
NCT03945604 COMPLETED
Triple Negative Breast Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-06-04 PHASE1
NCT04694365 Unknown status
Hepatic Impairment|Healthy Subjects
Jiangsu HengRui Medicine Co. Ltd.
 2020-11-06 Phase 1
NCT04517357 Unknown status
Relapsed Ovarian Cancer
Jiangsu HengRui Medicine Co. Ltd.
 2020-10-16 Phase 2
NCT04659785 Unknown status
Small Cell Lung Cancer Extensive Stage
Tianjin Medical University Second Hospital
 2020-07-01 Phase 1|Phase 2
NCT04333134 COMPLETED
Healthy Volunteers
Atridia Pty Ltd.
 2020-04-17 PHASE1
NCT04341077 UNKNOWN
Healthy Adult Male and Female Volunteers
Jiangsu HengRui Medicine Co., Ltd.
 2020-04-10 PHASE1
NCT04013048 COMPLETED
Solid Tumor
Jiangsu HengRui Medicine Co., Ltd.
 2019-07-08 PHASE1
NCT03645200 UNKNOWN
Advanced Cancer
Tianjin Medical University Second Hospital
 2019-07-01 PHASE1
NCT04108676 COMPLETED
Advanced Solid Tumor
Jiangsu HengRui Medicine Co., Ltd.
 2019-09-07 PHASE1
NCT04011124 COMPLETED
Healthy Male Subjects
Jiangsu HengRui Medicine Co., Ltd.
 2019-07-24 PHASE1
NCT04193319 COMPLETED
Advanced Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2019-07-19 PHASE1
NCT03509636 COMPLETED
Ovarian Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2018-04-04 PHASE1
NCT04521192 COMPLETED
Healthy Adult Subjects
Jiangsu HengRui Medicine Co., Ltd.
 2019-05-06 PHASE1
NCT02747342 COMPLETED
Neoplasm; Prostate Cancer
Atridia Pty Ltd.
 2016-09 PHASE1
NCT03182673 TERMINATED
Solid Tumor
Jiangsu HengRui Medicine Co., Ltd.
 2017-07-24 PHASE1
NCT02759666 COMPLETED
Neoplasm; Solid Tumors
Atridia Pty Ltd.
 2016-06-01 PHASE1
NCT02575651 COMPLETED
Advanced Solid Malignancies
Jiangsu HengRui Medicine Co., Ltd.
 2015-04 PHASE1
NCT03026881 UNKNOWN
Recurrent and Metastatic Gastric Cancer
Jiangsu HengRui Medicine Co., Ltd.
 2017-01 PHASE1
NCT03062982 COMPLETED
Solid Tumor
Jiangsu HengRui Medicine Co., Ltd.
 2016-12-21 PHASE1

(data from https://clinicaltrials.gov, updated on 2026-01-20)

Check the Fluzoparib (SHR-3162) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Fluzoparib selectively binds to and inhibits poly(ADP-ribose) polymerase 1 (PARP1), suppressing PARP-mediated base excision repair and trapping PARP-DNA complexes to cause double-strand DNA breaks during replication. This accumulation of DNA damage triggers cell cycle arrest and selective apoptosis in homologous recombination-deficient tumors, demonstrating therapeutic relevance in clinical studies for relapsed ovarian cancer and HER2-negative breast cancer.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.