# Saruparib

Source: https://onco.cc/drugs/saruparib/  
OnCo record `saruparib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: phase-3
- Last checked: 2026-10-06
- Tags: pipeline; ctgov-ingest
- Code: AZD5305
- Modality: small molecule
- Mechanism: PARP1-selective inhibitor and trapper (AZD5305).

## Sources

- ClinicalTrials.gov: trials of Saruparib: https://clinicaltrials.gov/search?intr=AZD5305
- ClinicalTrials.gov NCT04644068: https://clinicaltrials.gov/study/NCT04644068
- ClinicalTrials.gov NCT06380751: https://clinicaltrials.gov/study/NCT06380751
- ClinicalTrials.gov NCT07832630: https://clinicaltrials.gov/study/NCT07832630
- PETRA module 6 conference abstract: https://doi.org/10.1158/1557-3265.sabcs25-ps1-10-28

## Connected records

- cancers: [Advanced or recurrent endometrial cancer](https://onco.cc/cancers/advanced-recurrent-endometrial-cancer/), [Endometrial cancer](https://onco.cc/cancers/endometrial/), [Metastatic castration-resistant prostate cancer](https://onco.cc/cancers/prostate-mcrpc/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/), [Ovarian cancer](https://onco.cc/cancers/ovarian/), [Platinum-sensitive ovarian cancer](https://onco.cc/cancers/platinum-sensitive-ovarian-cancer/), [Prostate cancer](https://onco.cc/cancers/prostate/)
- targets: [PARP](https://onco.cc/targets/parp/)
- companies: [AstraZeneca](https://onco.cc/companies/astrazeneca/)
- trials: [A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer](https://onco.cc/trials/nct07060365/), [A Phase I/IIa Study of AZD8205 Given Alone or Combined, in Participants With Advanced/Metastatic Solid Malignancies](https://onco.cc/trials/nct05123482/), [A Platform Study of Novel Agents in Combination With Radiotherapy in NSCLC](https://onco.cc/trials/nct04550104/), [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](https://onco.cc/trials/nct06952803/), [A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.](https://onco.cc/trials/nct05938270/), [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](https://onco.cc/trials/nct07336446/), [Ascending Doses of Ceralasertib in Combination With Chemotherapy and/or Novel Anti Cancer Agents](https://onco.cc/trials/nct02264678/), [AZD5305 hADME in Patients With Advanced Solid Malignancies](https://onco.cc/trials/nct06713369/), [Drug-drug Interaction Study With AZD5305 and Itraconazole in Patients With Advanced Solid Malignancies](https://onco.cc/trials/nct05573724/), [Modular Clinical Pharmacology Study to Evaluate the Drug-drug Interaction Potential and Relative Bioavailability of Saruparib](https://onco.cc/trials/nct06899061/), [Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors](https://onco.cc/trials/nct05797168/), [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](https://onco.cc/trials/nct06380751/), [Saruparib (AZD5305) vs Placebo in Men With Metastatic Castration-Sensitive Prostate Cancer Receiving Physician's Choice New Hormonal Agents](https://onco.cc/trials/nct06120491/), [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)](https://onco.cc/trials/nct07711002/), [Saruparib in HRDsig+ Solid Tumors](https://onco.cc/trials/nct07832630/), [Study of AZD4956 as Monotherapy and in Combination With Anti-Cancer Agents in Participants With Advanced/Metastatic Homologous Recombination Deficient Solid Tumours](https://onco.cc/trials/nct07446855/), [Study of AZD5305 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies](https://onco.cc/trials/nct04644068/), [Study of AZD5305 When Given in Combination With New Hormonal Agents in Patients With Metastatic Prostate Cancer](https://onco.cc/trials/nct05367440/), [Using Biomarker Tests to Select and Test New, Personalized Treatments for Extensive Stage Small Cell Lung Cancer, PRISM Study](https://onco.cc/trials/nct06769126/)

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