Clinical Trials

Pamiparib is currently undergoing evaluation across numerous clinical trials spanning Early Phase 1 through Phase 3 for indications including epithelial ovarian cancer, platinum-resistant ovarian carcinoma, advanced solid tumors, non-small-cell lung cancer, and metastatic castration-resistant prostate cancer. Sponsored by both pharmaceutical industry leaders like BeiGene and academic medical centers, these protocols encompass various statuses, including completed, active recruiting, active non-recruiting, pending, and withdrawn. Together, these studies underscore the broad therapeutic potential of pamiparib in monotherapy and combination regimens for advanced malignancies.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05526924 RECRUITING
Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Head and Neck Carcinoma; Head and Neck Cancer Stage IV; Head and Neck Cancers - Throat
University of Chicago
2023-03-07 PHASE1
NCT06692491 NOT_YET_RECRUITING
Rare Tumour
Peking University Shenzhen Hospital
2025-01-01 PHASE2
NCT04796454 WITHDRAWN
Platinum-Sensitive Biliary Tract Cancer
European Organisation for Research and Treatment of Cancer - EORTC
2022-05 PHASE2
NCT04164199 COMPLETED
Advanced Malignancies
BeOne Medicines
2019-12-19 PHASE3
NCT05038839 COMPLETED
Advanced Malignant Solid Neoplasm; Refractory Malignant Solid Neoplasm
M.D. Anderson Cancer Center
2022-02-09 PHASE1
NCT06387056 RECRUITING
Locally Advanced Prostate Cancer; Oligometastatic Prostate Cancer
The First Affiliated Hospital of Xiamen University
2024-04-01 PHASE2
NCT03519230 ACTIVE_NOT_RECRUITING
Ovarian Cancer
BeiGene
2018-05-14 PHASE3
NCT04985721 UNKNOWN
Cancer
Peter MacCallum Cancer Centre, Australia
2022-02-24 PHASE2
NCT05327621 UNKNOWN
Metastatic Castration-resistant Prostate Cancer
Sun Yat-sen University
2022-05-01 PHASE2
NCT05044871 COMPLETED
Ovarian Cancer
Tongji Hospital
2022-07-22 PHASE2
NCT05483543 UNKNOWN
Limited Stage Small Cell Lung Cancer
Fudan University
2022-06-20 PHASE2
NCT05573373 UNKNOWN
Carcinoma, Non-Small-Cell Lung; EGF-R Positive Non-Small Cell Lung Cancer
Affiliated Hospital of Jiangnan University
2022-12-20 PHASE1
NCT05669768 UNKNOWN
Ovarian Cancer
Sun Yat-sen University
2023-01-01 PHASE2
NCT05494580 COMPLETED
Ovarian Cancer; Ovarian Carcinoma; Platinum-resistant Ovarian Cancer; Fallopian Tube Carcinosarcoma; Primary Peritoneal Cancer
Sun Yat-sen University
2022-09-22 PHASE1; PHASE2
NCT05489926 UNKNOWN
Epithelial Ovarian Cancer
Zhejiang Cancer Hospital
2022-08-16 PHASE2
NCT05652283 ACTIVE_NOT_RECRUITING
Ovarian Cancer
Bai-Rong Xia
2022-11-06 PHASE2
NCT05376722 UNKNOWN
Neoadjuvant Therapy
Hongqian Guo
2022-02-22 PHASE2
NCT04614909 COMPLETED
Glioblastoma; Glioblastoma Multiforme; Glioblastoma Multiforme, Adult
Nader Sanai
2021-01-11 EARLY_PHASE1
NCT04603365 WITHDRAWN
Clear Cell Papillary Renal Neoplasm; Collecting Duct Carcinoma; Hereditary Leiomyomatosis and Renal Cell Carcinoma; Hereditary Papillary Renal Cell Carcinoma; Metastatic Renal Cell Carcinoma; Metastatic Unclassified Renal Cell Carcinoma; Papillary Renal Cell Carcinoma; Stage III Renal Cell Cancer American Joint Committee on Cancer (AJCC) v8; Stage IV Renal Cell Cancer AJCC v8; Tubulocystic Renal Cell Carcinoma; Unresectable Renal Cell Carcinoma
Jonsson Comprehensive Cancer Center
2021-10-18 PHASE2
NCT03150810 COMPLETED
Locally Advanced or Metastatic Solid Tumors
BeiGene
2017-06-28 PHASE1
NCT05376722 Recruiting
Neoadjuvant Therapy
Hongqian Guo|First Affiliated Hospital of Zhejiang University|The First Affiliated Hospital of Soochow University|Nanjing First Hospital Nanjing Medical University|The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
2022-02-22 Phase 2
NCT04985721 Recruiting
Cancer
Peter MacCallum Cancer Centre Australia
2022-02-24 Phase 2
NCT03933761 WITHDRAWN
Ovarian Cancer; Carcinosarcoma
Australia New Zealand Gynaecological Oncology Group
2019-07-29 PHASE2
NCT03150862 COMPLETED
Brain and Central Nervous System Tumors
BeiGene USA, Inc.
2017-07-24 PHASE1; PHASE2
NCT02660034 COMPLETED
Solid Tumors
BeiGene
2016-02-02 PHASE1
NCT03333915 COMPLETED
Advanced High-grade Ovarian Cancer; Triple Negative Breast Cancer
BeiGene
2016-12-21 PHASE1; PHASE2
NCT03712930 TERMINATED
Metastatic Castration-Resistant Prostate Cancer (mCRPC); Homologous Recombination Deficiency (HRD)
BeiGene
2019-02-05 PHASE2
NCT03427814 COMPLETED
Advanced or Inoperable Gastric Cancer
BeiGene
2018-07-03 PHASE2
NCT03994211 COMPLETED
Solid Tumor
BeiGene
2019-05-29 PHASE1
NCT03991494 COMPLETED
Advanced Solid Tumors
BeiGene
2019-05-29 PHASE1
NCT03991494 Completed
Advanced Solid Tumors
BeiGene
2019-05-29 Phase 1

(data from https://clinicaltrials.gov, updated on 2026-03-04)

Check the Pamiparib product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Pamiparib potently and selectively binds to PARP1 and PARP2, inhibiting poly(ADP-ribosyl)ation and trapping PARP complexes onto damaged DNA to disrupt single-strand break repair. This persistence of unrepaired single-strand breaks generates lethal DNA double-strand breaks during cell replication, driving synthetic lethality and tumor cell apoptosis in clinical indications such as advanced epithelial ovarian cancer and solid tumors.

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>).

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