Saruparib (AZD5305)

DRUG4 trials

Sponsors

AstraZeneca

Conditions

Advanced Breast CancerEndometrial CancerLocally Advanced or Metastatic Solid TumorLung AdenocarcinomaOvarian CancerProstate Cancer

Phase 1

Phase I/IIa Study of AZD5335 as Monotherapy and Combination Therapy in Participants With Solid Tumors

RecruitingNCT05797168

AstraZenecaEndometrial Cancer, Lung Adenocarcinoma, Ovarian Cancer

Start: 2023-06-05End: 2028-01-06Target: 506Updated: 2026-03-02

A Study to Investigate the Biological Effects of Saruparib (AZD5305), Darolutamide, and in Combination in Men With Newly Diagnosed Prostate Cancer.

RecruitingNCT05938270

AstraZenecaProstate Cancer

Start: 2023-09-21End: 2026-08-17Target: 120Updated: 2026-02-24

AZD5305 hADME in Patients With Advanced Solid Malignancies

RecruitingNCT06713369

AstraZenecaLocally Advanced or Metastatic Solid Tumor

Start: 2025-04-02End: 2026-10-02Target: 8Updated: 2026-03-04

Phase 3

Saruparib (AZD5305) Plus Camizestrant 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

RecruitingNCT06380751

AstraZenecaAdvanced Breast Cancer

Start: 2024-08-01End: 2030-10-18Target: 500Updated: 2026-03-12

Related Papers

Abstract PS1-10-28: Phase 1/2a trial of new generation PARP1-selective inhibitor saruparib + next generation selective ER degrader (SERD) camizestrant in patients (pts) with advanced/relapsed ER+/HER2-negative or low (HER2−) breast cancer (PETRA Module 6)

Clinical Cancer Research2026-02-17

Abstract P2-10-17: A randomized phase III study of first-line saruparib (AZD5305) + camizestrant vs CDK4/6i plus physician’s choice endocrine therapy or + camizestrant in patients w/ BRCA1/BRCA2/PALB2 mutations & HR+/HER2- advanced breast cancer (EvoPAR-Breast01)

Clinical Cancer Research2025-06-131 citations

Abstract P2-09-23: Differential outcomes of patients with HR-positive/HER2-negative metastatic breast cancer and a pathogenic BRCA1/2 or PALB2 variant under first line CDK4/6 inhibition

Clinical Cancer Research2025-06-13

Abstract 4201: Combination of the PARP1-selective inhibitor saruparib with androgen receptor pathway inhibition provides combination benefit in preclinical models of prostate cancer with or without homologous recombination repair deficiency

Cancer Research2025-04-21

Abstract LB406: Synergistic antitumor effect of FRα TOP1i antibody drug conjugate, AZD5335, in combination with the PARP1 inhibitor, saruparib (AZD5305), in preclinical models of ovarian cancer

Cancer Research2024-04-05

ASCERTAIN: An open-label, randomized, phase 1, window-of-opportunity study to investigate the biological effects of AZD5305 and darolutamide alone or in combination in men with prostate cancer eligible for radical prostatectomy.

Journal of Clinical Oncology2024-01-291 citations

Modulatory Potential of Poly (ADP‐Ribose) Polymerase 1 (PARP1) in BRCA‐Mutated Tumors

European Journal of Cancer Care2024-01-011 citations