{"entity":{"id":"saruparib","kind":"drug","name":"Saruparib","aka":[],"tldr":"Saruparib is an experimental DNA-repair inhibitor in advanced trials for selected breast and prostate cancers. It selectively blocks PARP1.","summary":"Saruparib selectively inhibits PARP1. PETRA (NCT04644068) is active but not recruiting, with 702 actual participants in its current registry record. A 2026 conference abstract for module 6 of saruparib plus camizestrant reported eight confirmed partial responses among 35 evaluable patients with previously treated ER-positive/HER2-negative breast cancer (22.9%); 38 were treated. Median progression-free survival was 4.4 months (80% CI 2.0-5.6). The nine evaluable BRCA/PALB2-altered patients had a 33.3% response rate; these small, uncontrolled groups do not establish benefit in TNBC. EvoPAR-Breast01 (NCT06380751) is recruiting and selects HR-positive/HER2-negative advanced breast cancer with BRCA1/2 or PALB2 alterations; it is not a TNBC study. Phase 3 prostate studies and a planned HRD-signature-selected phase 2 solid-tumour study expand the pipeline. PARP1 selectivity aims to improve the therapeutic window but does not prove freedom from marrow toxicity.","status":"phase-3","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov: trials of Saruparib","url":"https://clinicaltrials.gov/search?intr=AZD5305"},{"label":"ClinicalTrials.gov NCT04644068","url":"https://clinicaltrials.gov/study/NCT04644068"},{"label":"ClinicalTrials.gov NCT06380751","url":"https://clinicaltrials.gov/study/NCT06380751"},{"label":"ClinicalTrials.gov NCT07832630","url":"https://clinicaltrials.gov/study/NCT07832630"},{"label":"PETRA module 6 conference abstract","url":"https://doi.org/10.1158/1557-3265.sabcs25-ps1-10-28"}],"tags":["pipeline","ctgov-ingest"],"related":[],"cancers":["prostate","ovarian","nsclc","endometrial"],"sections":[],"technologies":[],"targets":["parp"],"drugs":[],"companies":["astrazeneca"],"institutions":[],"pathways":[],"terms":[],"trials":["nct06952803","nct06120491","nct05797168","nct05367440","nct05123482","nct07336446","nct04644068","nct07446855","nct06380751","nct02264678","nct07711002","nct04550104","nct07060365","nct07832630","nct06899061","nct05938270","nct06769126","nct05573724","nct06713369"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo ingestion (ClinicalTrials.gov v2 + sponsor pipeline pages)","editedOn":"2026-09-11"},"code":"AZD5305","modality":"small molecule","mechanism":"PARP1-selective inhibitor and trapper (AZD5305).","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/saruparib/","neighbours":{"cancer":[{"id":"advanced-recurrent-endometrial-cancer","kind":"cancer","name":"Advanced or recurrent endometrial cancer","route":"/cancers/advanced-recurrent-endometrial-cancer/"},{"id":"endometrial","kind":"cancer","name":"Endometrial cancer","route":"/cancers/endometrial/"},{"id":"prostate-mcrpc","kind":"cancer","name":"Metastatic castration-resistant prostate cancer","route":"/cancers/prostate-mcrpc/"},{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"},{"id":"ovarian","kind":"cancer","name":"Ovarian cancer","route":"/cancers/ovarian/"},{"id":"platinum-sensitive-ovarian-cancer","kind":"cancer","name":"Platinum-sensitive ovarian cancer","route":"/cancers/platinum-sensitive-ovarian-cancer/"},{"id":"prostate","kind":"cancer","name":"Prostate cancer","route":"/cancers/prostate/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"company":[{"id":"astrazeneca","kind":"company","name":"AstraZeneca","route":"/companies/astrazeneca/"}],"trial":[{"id":"nct07060365","kind":"trial","name":"A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer","route":"/trials/nct07060365/"},{"id":"nct05123482","kind":"trial","name":"A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies","route":"/trials/nct05123482/"},{"id":"nct04550104","kind":"trial","name":"A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC","route":"/trials/nct04550104/"},{"id":"nct06952803","kind":"trial","name":"A Study of Metastases Free Survival With Saruparib vs Placebo Added to a Standard RT/ADT in Men With High-risk Prostate Cancer With a BRCA Mutation","route":"/trials/nct06952803/"},{"id":"nct05938270","kind":"trial","name":"A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.","route":"/trials/nct05938270/"},{"id":"nct07336446","kind":"trial","name":"A Trial to Learn How Safe AZD9750 is and How Well it Works in People With Metastatic Prostate Cancer When Given With or Without Other Anticancer Drugs","route":"/trials/nct07336446/"},{"id":"nct02264678","kind":"trial","name":"Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents","route":"/trials/nct02264678/"},{"id":"nct06713369","kind":"trial","name":"AZD5305 hADME in Patients With Advanced Solid Malignancies","route":"/trials/nct06713369/"},{"id":"nct05573724","kind":"trial","name":"Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies","route":"/trials/nct05573724/"},{"id":"nct06899061","kind":"trial","name":"Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib","route":"/trials/nct06899061/"},{"id":"nct05797168","kind":"trial","name":"Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors","route":"/trials/nct05797168/"},{"id":"nct06380751","kind":"trial","name":"Saruparib (AZD5305) Plus Camizestrant or Plus Endocrine Therapy, Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer","route":"/trials/nct06380751/"},{"id":"nct06120491","kind":"trial","name":"Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents","route":"/trials/nct06120491/"},{"id":"nct07711002","kind":"trial","name":"Saruparib in Combination With Physician's Choice of ARPI in Patients With mHSPC Previously Treated With Docetaxel or 177Lu-PSMA Therapy Without Disease Progression and PSA ≥ 0.2 ng/mL (EvoPAR-PR05)","route":"/trials/nct07711002/"},{"id":"nct07832630","kind":"trial","name":"Saruparib in HRDsig+ Solid Tumors","route":"/trials/nct07832630/"},{"id":"nct07446855","kind":"trial","name":"Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours","route":"/trials/nct07446855/"},{"id":"nct04644068","kind":"trial","name":"Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies","route":"/trials/nct04644068/"},{"id":"nct05367440","kind":"trial","name":"Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer","route":"/trials/nct05367440/"},{"id":"nct06769126","kind":"trial","name":"Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study","route":"/trials/nct06769126/"}]}}