AiRuiYi (fluzoparib) / Jiangsu Hengrui Pharma - LARVOL DELTA

RAFAS-001: Brachytherapy (Iodine-125 Seeds) and Fluzoparib Combination Therapy for Advanced Unresectable Soft Tissue Sarcoma (clinicaltrials.gov) - P2 | N=32 | Recruiting | Sponsor: Fujun Zhang | Trial completion date: Dec 2024 ➔ Dec 2028 | Trial primary completion date: Jun 2024 ➔ Dec 2028

Trial completion date • Trial primary completion date • Oncology • Sarcoma • Soft Tissue Sarcoma • Solid Tumor

Case Report: Two cases of chemotherapy refractory aggressive variant prostate cancer with extreme durable response to PARP inhibitor. (PubMed, Front Oncol) - "He was treated with docetaxel/albumin-bound paclitaxel and cisplatin in the first line. Second-line therapy was applied with radiotherapy and Olaparib after failure of first-line therapy, resulting in a PSA response sustained for three years...Radiotherapy and Fluzoparib + abiraterone was applied as subsequent treatments with a PSA response for 2 years. These two cases demonstrating a satisfactorily durable response to PARP inhibitors indicating its clinical benefit in AVPC population with detected DNA damage response (DDR) defects. The survival improvement with PARP inhibitors observed in our clinical experiences, along with current advances in tumor sequencing provide more information on future clinical trials and explorations of innovative therapies in AVPC population."

Journal • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA2 • FANCA • HDAC2 • PTEN • RB1 • TP53

Fluzoparib+Bevacizumab/Dietary Intervention vs Fluzoparib Monotherapy as First-line Maintenance in HRD+/- Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=424 | Not yet recruiting | Sponsor: Tongji Hospital

Monotherapy • New P3 trial • Oncology • Ovarian Cancer • Solid Tumor

Phase ib/II study of fluzoparib in combination with dalpiciclib in patients with locally advanced or metastatic sarcoma. (ASCO 2025) - P2 | "Clinical Trial Registration Number: NCT05952128 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Combination therapy • Metastases • P1/2 data • Oncology • Sarcoma • Solid Tumor

Clinical Practice of Poly (ADP-Ribose) Polymerase Inhibitors for Maintenance Treatment of Platinum-Sensitive Recurrent Ovarian Cancer in China. (PubMed, BJOG) - "Clinical trials of three poly (ADP-ribose) polymerase (PARP) inhibitors, olaparib, niraparib and fuzuloparib, in platinum-sensitive recurrent ovarian cancer (PSR OC) in China showed that PARP inhibitors improved progression-free survival and achieved an all-comer indication in this population. We reviewed the efficacy and safety of these PARP inhibitors in patient populations studied in clinical trials and highlighted the positive role of PARP inhibitors in improving patient outcomes using clinical trials and real-world studies conducted in China. This article also discusses the issues encountered in clinical practice and how to evaluate the different indications for PSR OC in China and abroad."

Journal • Platinum sensitive • Review • Oncology • Ovarian Cancer • Solid Tumor

Research Progress of M6A Methylation Modification in Immunotherapy of Colorectal Cancer. (PubMed, Curr Cancer Drug Targets) - "This review has sys-tematically summarized the latest clinical application of six authorized PARPi, including olaparib, rucaparib, niraparib, talazoparib, fuzuloparib and pamiparib, in monotherapy and combination therapies with chemotherapy, radiotherapy, and immunotherapy, in different kinds of cancer. Furthermore, probable challenges in PARPi application and drug resistance mechanisms have also been discussed. Despite these challenges, further development of new PARP1 inhibitors appears promising as a valuable approach to cancer treatment."

Journal • Colorectal Cancer • Oncology • Solid Tumor

Safety and effectiveness of fuzuloparib in patients with ovarian cancer: A nationwide, multicenter, prospective real-world study. (ASCO 2025) - P=N/A | "Clinical Trial Registration Number: NCT05206890 The abstract will be released to the public on May 22, 2025 at 4:00 PM CDT"

Clinical • Real-world • Real-world evidence • Oncology • Ovarian Cancer • Solid Tumor

Engaging an engineered PARP-2 catalytic domain mutant to solve the complex structures harboring approved drugs for structure analyses. (PubMed, Bioorg Chem) - "Consequently, the complex structures of Fluzoparib, Pamiparib, Rucaparib, and Niraparib within PARP-2 were achieved. It suggested that the residues adjacent to Asp766 in the HD and ASL domains and the αJ-αF and ASL-αD interfaces were closely related to the selectivity and trapping mechanism. These results would provide some insights for the design and development of novel PARP-1/2 inhibitors with improved pharmacodynamic properties."

Journal • Oncology • PARP1 • PARP2

Neoadjuvant SNF Precision Therapy Phase III (clinicaltrials.gov) - P3 | N=404 | Not yet recruiting | Sponsor: Fudan University

New P3 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor

Fluzoparib plus apatinib maintenance in patients with platinum-sensitive recurrent ovarian cancer who had received first-line maintenance with a PARP inhibitor (FLASH): A single-arm exploratory trial (SGO 2025) - No abstract available

Clinical • Oncology • Ovarian Cancer • Solid Tumor

Maintenance Therapy with Fuzuloparib plus Adebrelimab for ES-SCLC after First-Line Induction with Fuzuloparib plus Adebrelimab and Chemotherapy: A Prospective, Single-Arm, Phase II Clinical Study (ELCC 2025) - P2 | "Eligible pts will intravenously receive four 21-day cycles of adebrelimab (1200 mg, day 1) and fuzuloparib (100 mg, twice a day) with carboplatin (area under the curve of 5 mg/ml per min, day 1) and etoposide (100 mg/m2 bodysurface area, days 1–3) in induction phase; pts with disease control will receive maintenance treatment with adebrelimab and fuzuloparib until disease progression or no clinical benefit. The secondary endpoints include OS, objective response rate (ORR), duration of response (DoR) and safety. Enrolment of participants is ongoing."

Clinical • IO biomarker • P2 data • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Neoadjuvant fuzuloparib combined with abiraterone for localized high-risk prostate cancer (FAST-PC): A single-arm phase 2 study. (PubMed, Cell Rep Med) - P2 | "Post-treatment genomic analyses reveal reduced MYC amplification and proliferation markers, alongside activated epithelial-mesenchymal transition/activator protein 1 (AP-1) pathways. The trial meets its primary endpoint, demonstrating feasibility and preliminary efficacy, while exploratory biomarkers may guide future studies."

Journal • P2 data • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor • BRCA2 • HRD • MYC

Fluzoparib in Combination With Camrelizumab and Temozolomide in Advanced Melanoma (clinicaltrials.gov) - P1/2 | N=50 | Recruiting | Sponsor: Jun Guo | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Dec 2027 | Trial primary completion date: Dec 2024 ➔ Dec 2026

Enrollment open • Trial completion date • Trial primary completion date • Melanoma • Oncology • Solid Tumor • SF3B1

Response to PARP inhibitor in EGFR-tyrosine kinase inhibitor-resistant metastatic lung adenocarcinoma with germline PALB2 mutation. (PubMed, Anticancer Drugs) - "We present a case of EGFR-tyrosine kinase inhibitor-resistant metastatic lung adenocarcinoma with a germline PALB2 mutation that was treated with fluzoparib (an orally administered PARPi). The treatment achieved surprising results and lasted for more than 4.5 months. Our study provided evidence that metastatic lung adenocarcinoma with germline PALB2 could benefit from PARPi, which improves patient outcomes."

Journal • Lung Adenocarcinoma • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor • EGFR • HRD • PALB2

FZPL-II-201: A Phase 2 Trial of Fluzoparib Combined With Apatinib Versus Fluzoparib Monotherapy in Treatment With Relapsed Ovarian Cancer Patients (clinicaltrials.gov) - P2 | N=100 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Completed | Trial completion date: Mar 2022 ➔ Nov 2024

Monotherapy • Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor

Phase II Study of Irinotecan Liposome (II) Combined With Temozolomide and Fluzoparib in Recurrent or Metastatic Ewing Sarcoma (clinicaltrials.gov) - P2 | N=29 | Not yet recruiting | Sponsor: Sun Yat-sen University

New P2 trial • Ewing Sarcoma • Oncology • Sarcoma • Solid Tumor

Simultaneously delivery of functional gallium ions and hydrogen sulfide to endow potentiated treatment efficacy in chemo- and PARPi-resistant ovarian cancer. (PubMed, J Nanobiotechnology) - "More importantly, the therapeutic efficacy of Ga2S3-BSA NMs and their ability to enhance the sensitivity to carboplatin and fluzoparib with negligible toxicity were further confirmed in a platinum-resistant OC animal model. Altogether, our results demonstrated a potentially safe and practical strategy by using Ga2S3-BSA NMs to combat drug resistance in platinum-resistant OC."

IO biomarker • Journal • Oncology • Ovarian Cancer • Solid Tumor • BCL2

Clinical Application of PARP1 Inhibitors and Challenges in Cancer Therapy. (PubMed, Curr Cancer Drug Targets) - "This review has systematically summarized the latest clinical application of six authorized PARPi, including olaparib, rucaparib, niraparib, talazoparib, fuzuloparib and pamiparib, in monotherapy and combination therapies with chemotherapy, radiotherapy, and immunotherapy, in different kinds of cancer. Furthermore, probable challenges in PARPi application and drug resistance mechanisms have also been discussed. Despite these challenges, further development of new PARP1 inhibitors appears promising as a valuable approach to cancer treatment."

Journal • Oncology

A Trial of SHR3162 Combined With Apatinib Mesylate Tablets or SHR3162 Monotherapy in Patients With Metastatic Castration Resistant Prostate Cancer (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Active, not recruiting ➔ Completed

Monotherapy • Trial completion • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • HRD

Adebrelimab combined with chemotherapy followed by adebrelimab plus albumin-bound paclitaxel/apatinib/fluzoparib as first-line treatment for extensive-stage small cell lung cancer: a prospective, multicenter, open, parallel cohort study (ChiCTR) - P4 | N=105 | Sponsor: The Affiliated Hospital of Xuzhou Medical University; The Affiliated Hospital of Xuzhou Medical University

New P4 trial • Lung Cancer • Oncology • Small Cell Lung Cancer • Solid Tumor

Fluzoparib as Neoadjuvant Treatment for BRCA Germline Mutation HER2-Negative Early Breast Cancer: An Open-Label, Single-Arm, Single-Center Study (ChiCTR) - P2 | N=30 | Recruiting | Sponsor: Beijing Cancer Hospital; Beijing Cancer Hospital

New P2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • Oncology • Solid Tumor • BRCA1 • BRCA2 • HER-2

Sacituzumab Govitecan in the Treatment of Recurrent Triple-Negative Breast Cancer in a Patient with HRD-Positive and BRCA1/2 Wild-Type Germline: A Case Report (ESMO Asia 2024) - P2 | "Neoadjuvant chemotherapy with paclitaxel, doxorubicin, and cyclophosphamide from August to October 2021 demonstrated initial stable disease (SD), followed by progressive disease (PD) after albumin-bound paclitaxel and carboplatin (November 2021-January 2022), and vinorelbine and carboplatin (February-April 2022).Progressive disease occurred after two cycles of each treatment regimen.Post-mastectomy genomic profiling showed wild-type germline BRCA1/2 and a high score for homologous recombination deficiency (HRD)...In May 2023, she enrolled in an Investigator-Initiated Clinical Trial (NCT05085626), receiving fluzoparib and chidamide, which ultimately led to progressive disease...However, liver metastases identified in March 2024 and subsequent treatment with trastuzumab deruxtecan resulted in progressive disease after two cycles...As an ADC with a topoisomerase I inhibitor payload, the activity of sacituzumab govitecan in this setting underscores the potential for..."

Case report • Clinical • IO biomarker • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA1 • BRCA2 • HRD

Adebrelimab plus chemotherapy and bevacizumab induction therapy followed by maintenance therapy with adebrelimab plus fluzoparib and bevacizumab in platinum-sensitive relapsed ovarian cancer (CHANGCHUN): A single-arm, exploratory study (ESMO Asia 2024) - P2, P3 | "Background The phase II OPEB-01/APGOT-OV4 study (NCT04361370) suggested that triplet maintenance therapy of bevacizumab, olaparib, and pembrolizumab achieved durable efficacy and tolerable safety in patients with BRCA wild-type, platinum-sensitive recurrent ovarian cancer. Findings of the Phase III DUO-O trial (NCT03737643) indicated that induction chemotherapy plus bevacizumab with durvalumab, followed by triplet maintenance with durvalumab, bevacizumab, and olaparib could increase progression-free benefit in patients with newly diagnosed advanced ovarian cancer without tumor BRCA1/2 mutation...All patients will receive paclitaxel/carboplatin plus bevacizumab and adebrelimab (a PD-L1 monoclonal antibody) induction therapy followed by maintenance therapy with bevacizumab plus adebrelimab and fluzoparib (a PARP inhibitor) until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator assessment that continuation is..."

Clinical • IO biomarker • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study of Fuzuloparib Combined With Abiraterone Acetate and Prednisone (AA-P) Versus Placebo Combined With AA-P as First-Line Treatment in Patients With Metastatic Castration-Resistant Prostate Cancer (clinicaltrials.gov) - P3 | N=496 | Active, not recruiting | Sponsor: Jiangsu HengRui Medicine Co., Ltd. | Recruiting ➔ Active, not recruiting | N=804 ➔ 496

Enrollment change • Enrollment closed • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • Oncology • Prostate Adenocarcinoma • Prostate Cancer • Solid Tumor • DRD

FASCINATE-N: Fudan University Shanghai Cancer Center Breast Cancer Precision Platform Series Study- Neoadjuvant Therapy (clinicaltrials.gov) - P2 | N=716 | Recruiting | Sponsor: Fudan University | Trial primary completion date: Sep 2024 ➔ Dec 2024

Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • CD8 • FOXC1 • HER-2 • PGR