Paishuning (senaparib) / IMPACT Therap, Huadong Medicine - LARVOL DELTA

Efficacy and Safety of Senaparib Maintenance Therapy in Patients with p53-Abnormal Endometrial Carcinoma After Adjuvant Chemotherapy (ChiCTR) - P=N/A | N=42 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

New trial • P53mut • Endometrial Cancer • Oncology • Solid Tumor • TP53

Multicenter, Single-Arm, Prospective Clinical Study on Senaparib Combined with Bevacizumab for First-Line Maintenance Therapy in Newly Diagnosed BRCA Wild-Type Advanced Ovarian Cancer (ChiCTR) - P4 | N=62 | Recruiting | Sponsor: Women’s Hospital, Zhejiang University School of Medicine; Women’s Hospital, Zhejiang University School of Medicine

New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Real-world study of senaparib capsule as first-line maintenance treatment in patients with newly diagnosed advanced ovarian cancer, primary peritoneal cancer，or fallopian tube cancer (ChiCTR) - P4 | N=30 | Not yet recruiting | Sponsor: Henan Provincial People's Hospita,medical; Henan Provincial People's Hospita,medical

New P4 trial • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A real-world study on the use of Senaparib for first-line maintenance treatment of newly diagnosed BRCAwt advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: The Second Affiliated Hospital of Zhejiang University School of Medicine; The Second Affiliated Hospital of Zhejiang University School of Medicine

New P4 trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor

A Single-Center, Prospective Clinical Study of Senaparib Alone or in Combination with Bevacizumab as First-Line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination-Proficient (HRP) Ovarian Cancer (ChiCTR) - P4 | N=50 | Not yet recruiting | Sponsor: Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sciences); Guangdong Provincial People's Hospital(Guangdong Academy of Medical Sci

New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Study on the efficacy and safety of QL1706 combined with Senaparib in neoadjuvant therapy for ovarian Cancer: A prospective, single-arm clinical study (ChiCTR) - P=N/A | N=20 | Not yet recruiting | Sponsor: The Fourth Hospital of Hebei Medical University; Fourth Hospital of Hebei Medical University

New trial • Oncology • Ovarian Cancer • Solid Tumor

A Single-Arm Prospective Clinical Study of Senaparib as First-Line Maintenance Treatment in HRD-Negative Advanced Epithelial Ovarian Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer (ChiCTR) - P=N/A | N=60 | Recruiting | Sponsor: Sun Yat-sen University Cancer Center (Sun Yat-sen University Cancer Hospital, Sun Yat-sen University Cancer Research Institute); Sun Yat-sen Universit

New trial • Epithelial Ovarian Cancer • Fallopian Tube Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Solid Tumor • HRD • MUC16

Poly (ADP-ribose) polymerase (PARP) inhibitors approved for the treatment of cancer. (PubMed, Pharmacol Res) - "The FDA has approved four PARP inhibitors (olaparib, rucaparib, niraparib, and talazoparib) for the treatment of ovarian, breast, prostate, and pancreatic cancer...The Chinese NMPA has approved three PARP antagonists (fuzuloparib, pamiparib, senaparib) for the treatment of ovarian cancer. All seven of these drugs are orally bioavailable and fall within the criteria of Lipinski's rule of five. Drug resistance develops in most PARP-inhibitor-treated cancer patients within one or two years."

Journal • Review • Breast Cancer • Genito-urinary Cancer • Oncology • Ovarian Cancer • Pancreatic Cancer • Prostate Cancer • Solid Tumor • BRCA1 • BRCA2 • HRD

Unveiling the power of PARP inhibitors: a meta-analysis on newly diagnosed advanced ovarian cancer maintenance therapy. (PubMed, Expert Rev Anticancer Ther) - "Notably, senaparib showed superior PFS efficacy compared to veliparib and niraparib. PARPi showed efficacy in improving PFS as maintenance therapy for newly diagnosed advanced OC, although no OS advantage was observed. PROSPERO (CRD420251020275)."

Journal • Retrospective data • Review • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

PARP Inhibitor Maintenance After First-Line Chemotherapy in Advanced-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-Analysis. (PubMed, JAMA Netw Open) - "Observed treatment efficacy and toxic effects varied across PARP inhibitor regimens; for example, the risk ratio for any recurrence or death in the overall study group ranged from 0.53 (95% CI, 0.40-0.70) for senaparib to 0.83 (95% CI, 0.68-1.00) for olaparib, while the risk ratio for high-grade adverse events ranged from 1.15 (95% CI, 0.64-2.06) for veliparib to 4.73 (95% CI, 2.77-8.07) for niraparib. In this study, no subgroup showed an association between first-line PARP inhibitor maintenance therapy in advanced-stage EOC and improved OS, and findings suggest that the consistency of associated PFS benefits may vary, particularly in homologous recombination proficient and BRCA wild type tumors. Variability in efficacy and toxic effects across subgroups and PARP inhibitor regimens underscores the importance of individualized treatment decisions."

Clinical • Journal • Retrospective data • Review • Epithelial Ovarian Cancer • Oncology • Ovarian Cancer • Solid Tumor • BRCA • HRD

Senaparib plus Bevacizumab as First-Line Maintenance in Ovarian Cancer with Homologous Recombination Proficient and Exploration of Biomarkers (ChiCTR) - P4 | N=37 | Not yet recruiting | Sponsor: Fudan University Shanghai Cancer Center; Fudan University Shanghai Cancer Center

Biomarker • New P4 trial • Oncology • Ovarian Cancer • Solid Tumor • MUC16

Efficacy and safety of maintenance therapy with senaparib in patients with platinum-sensitive recurrent ovarian cancer previously treated with PARP inhibitors (ChiCTR) - P4 | N=40 | Not yet recruiting | Sponsor: Peking Union Medical College Hospital; Peking Union Medical College Hospital

New P4 trial • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MUC16

Senaparib monotherapy for patients (pts) with BRCA1/2 mutated recurrent platinum-sensitive ovarian cancer (PSOC): Final analysis of study SABRINA (ESMO 2025) - P2 | "2 pts reported fatal TEAEs, 1 cerebral haemorrhage and 1 cerebral infarction, both of them were not related to senaparib. Conclusions Senaparib demonstrated clinically meaningful antitumor activity and manageable safety profile in BRCA1/2 mutated recurrent PSOC."

Clinical • Monotherapy • Platinum sensitive • Oncology • Ovarian Cancer • Solid Tumor • BRCA • BRCA1 • BRCA2

PET imaging of PARP-1 expression using a novel 18 F-labeled probe based on Quinazoline-2,4(1 H,3 H)-dione Scaffold (EANM 2025) - "Based on the core binding structure of Senaparib, we aimed to synthesize a novel probe targeting PARP-1 for PET with high feasibility, high binding selectivity, and a favorable tumor-to-background ratio...Conclusion Photocatalytic radiofluorination enables the facile synthesis of a PARP-1-targeted probe with high specificity and favorable contrast. Further studies on treatment response prediction will be performed in preclinical models."

HRD • PARP1

A Study of Absorption-Distribution-Metabolism-Excretion (ADME) of [14C]IMP4297 to China Healthy Male Subjects (clinicaltrials.gov) - P1 | N=6 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fasting Condition (clinicaltrials.gov) - P1 | N=28 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

SABRINA: Study of IMP4297 in Patients With BRCA1/2 Mutation Ovarian Cancer (clinicaltrials.gov) - P2 | N=93 | Completed | Sponsor: Impact Therapeutics, Inc. | Recruiting ➔ Completed | Trial completion date: Aug 2022 ➔ Dec 2024

Trial completion • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA1 • BRCA2 • MUC16

An BE Study to Compare 10mg & 20mg of IMP4297 Capsules in Healthy Chinese Subjects Under Fed Condition (clinicaltrials.gov) - P1 | N=36 | Completed | Sponsor: Impact Therapeutics, Inc. | Not yet recruiting ➔ Completed

Trial completion • Solid Tumor

Combination Therapy of Senaparib and Bevacizumab for First-line Maintenance Therapy in Newly Diagnosed Advanced Homologous Recombination Proficient Ovarian Cancer Based on Exosome Protein Marker (clinicaltrials.gov) - P2 | N=37 | Not yet recruiting | Sponsor: Fudan University

New P2 trial • Oncology • Ovarian Cancer • Solid Tumor

Senaparib: First Approval. (PubMed, Drugs) - "Senaparib (®; Sainapali Jiaonang) is a novel PARP inhibitor that potently inhibits PARP1 and PARP2, which is being developed by IMPACT Therapeutics for the treatment of advanced ovarian cancer and small-cell lung cancer. This article summarizes the milestones in the development of senaparib leading to this first approval for the maintenance treatment of adults with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who achieved a complete or partial response to first-line platinum-based chemotherapy."

Journal • Fallopian Tube Cancer • Lung Cancer • Oncology • Ovarian Cancer • Peritoneal Cancer • Small Cell Lung Cancer • Solid Tumor • PARP2

A Phase I, Open-label, Dose-escalation Study of the Safety and Pharmacokinetics of IMP4297 in Patients with Advanced Solid Tumors (ANZCTR) - P1 | N=30 | Completed | Sponsor: IMPACT Therapeutics Australia Pty Ltd | Recruiting ➔ Completed

Trial completion • Breast Cancer • Ovarian Cancer • Prostate Cancer • Solid Tumor • BRCA

A Bioequivalence Study to Compare Senaparib Manufactured at 2 Sites in Healthy Subjects in Fasting State (clinicaltrials.gov) - P1 | N=32 | Completed | Sponsor: Impact Therapeutics, Inc.

New P1 trial • Solid Tumor

FLAMES: A Study of IMP4297 as Maintenance Treatment Following First-line Chemotherapy in Patients With Advanced Ovarian Cancer (clinicaltrials.gov) - P3 | N=404 | Active, not recruiting | Sponsor: Impact Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial completion date: Dec 2022 ➔ Jun 2026

Enrollment closed • Monotherapy • Trial completion date • Oncology • Ovarian Cancer • Solid Tumor • BRCA • MUC16

An Bioequivalence Study to Compare 10mg & 20mg of Senaparib Capsules in Healthy Chinese Subjects Under Fasting Condition (clinicaltrials.gov) - P1 | N=40 | Completed | Sponsor: Impact Therapeutics, Inc.

New P1 trial • Solid Tumor

Discovery and development of a potent and highly selective ATR inhibitor IMP9064 (AACR 2025) - P1/2 | "IMP9064 has entered a phase 1/2 study to evaluate the safety and efficacy either as monotherapy or in combination with PARP inhibitor Senaparib in patients with advanced solid tumors (ClinicalTrials.gov Identifier: NCT05269316). The recommended phase 2 dose (RP2D) has been determined and IMP9064 is currently in expansion studies for selected tumors."

Colorectal Cancer • Oncology • Solid Tumor • PKMYT1