A Master Protocol Study to Investigate Biomarker-guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy in Participants With Advanced/Recurrent Ovarian Cancer

NCT07060365 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: D9724C00001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The main purpose of this study is to investigate the safety, tolerability, preliminary efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of biomarker-guided novel anticancer agent(s) as monotherapy or combination therapy for the treatment of participants with advanced/recurrent ovarian cancer. Substudy 1 will investigate the safety, tolerability, preliminary efficacy, PK and PD of saruparib monotherapy in participants with BReast CAncer gene (BRCA) mutated epithelial ovarian, fallopian tube, or primary peritoneal cancer.

Conditions

Advanced/Recurrent Ovarian Cancer

Keywords

Novel Anticancer Agent; Biomarker-Guided; Novel PARPi; BRCA1/2m; Neoadjuvant treatment

Outcome Measures

Primary Outcomes (1)

• Number of participants with treatment-emergent adverse event (TEAEs), serious adverse events (SAEs), and adverse events (AEs) leading to discontinuation

  To assess the safety and tolerability of novel biomarker guided treatment in participants with advanced/recurrent ovarian cancer.

  From Day 1 to Survival Follow up (approximately 6 months)

Secondary Outcomes (7)

• Substudy 1: Estimate of objective response rate (ORR) defined as proportion of participants who have a complete or partial response

  From Day 1 to IDS surgery (within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

• Substudy 1: Estimate of confirmed cancer antigen 125 (CA125) response rate defined as at least 50% reduction in serum CA-125 levels from pre-treatment levels

  Screening (Day -28), Day 1 (Cycle 1) and Day 15 (Cycle 2) (28-day cycles), End of Treatment (7 days after final dose), Pre-surgery Follow up

• Substudy 1: Proportion of participants with pathological complete response (pCR) defined as no macroscopic residual and no microscopic (viable) disease on histologic evaluation of all surgical specimens

  IDS Follow up period (IDS surgery within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

• Substudy 1: Proportion of participants with complete surgical resection of tumour at IDS defined as no macroscopic tumour remains after surgery

  IDS Follow up period (IDS surgery within 6 weeks after conclusion of study intervention treatment [Day 1 until 12 weeks])

• Substudy 1: Area under the plasma drug concentration-time curve (AUC)

  Day 1 (Cycle 1 and Cycle 3) (28-day cycles)

Study Arms (1)

Saruparib

EXPERIMENTAL

Participants will receive saruparib via oral administration.

Drug: Saruparib

Interventions

Saruparib DRUG

Participants will receive saruparib via oral administration.

Saruparib

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Master Protocol:
• Participants who have histologically or cytologically documented advanced or recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, considered to be suitable for treatment with study intervention, as applicable to each substudy.
• Participants must provide sufficient archival or fresh tumour sample for biomarker testing.
• Life expectancy at the time of screening ≥ 12 weeks in the opinion of the Investigator.
• Measurable disease as per RECIST 1.1 criteria: at least one lesion that can be accurately measured at baseline as ≥ 10 mm in the longest diameter.
• ECOG PS of 0 to 1, with no deterioration over the previous 2 weeks prior to baseline at screening, and prior to study intervention administration.
• Adequate organ and marrow function.
• Substudy 1:
• Participants must have histologically or cytologically confirmed newly diagnosed FIGO 2014 Stage III/IV epithelial ovarian\*, fallopian tube, or primary peritoneal cancer who are eligible for neoadjuvant treatment with planned IDS.
• Participants who are treatment-naïve.
• Participants with evidence of predicted loss of function tBRCA1/2m (by local testing) as assessed by a commercially available diagnostic test.

You may not qualify if:

• Master Protocol:
• Any history of persisting (\> 2 weeks) severe pancytopenia due to any cause (absolute neutrophil count \< 0.5 × 10/Liters (L) or platelets \< 50 × 10/L).
• Spinal cord compression or brain metastases unless asymptomatic, treated, and stable and not requiring continuous corticosteroids prednisone/day or dexamethasone or equivalent for at least 4 weeks prior to start of study intervention. Participants with leptomeningeal carcinomatosis are excluded.
• Active primary immunodeficiency/active infectious disease(s).
• Participants with any known predisposition to bleeding (eg, active peptic ulceration, recent \[within 6 months\] haemorrhagic stroke, proliferative diabetic retinopathy).
• Cardiac criteria, including history of arrhythmia and cardiovascular disease.
• Prior malignancy that required treatment within 2 years prior to screening.
• Previous allogeneic bone marrow or solid organ transplant.
• As judged by the Investigator, any evidence of severe or uncontrolled systemic diseases or active uncontrolled infections.
• Known allergy or hypersensitivity to investigational product(s) or any of the excipients of the investigational product(s) (as applicable to a substudy).
• Concomitant use of drugs that are known to prolong or shorten QT and have a known risk of (Torsades de Pointes) TdP.
• During the 4 weeks prior to the first dose, receiving continuous corticosteroids prednisone/day or equivalent for any reason.
• Major surgical procedure (excluding placement of vascular access) or significant traumatic injury.
• Any concurrent anticancer therapy.
• Substudy 1:

Sponsors & Collaborators

• AstraZeneca: lead
• Parexel: collaborator

Study Sites (1)

Research Site

Barcelona, 08028, Spain

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 11, 2025
• Study Start: September 2, 2025
• Primary Completion: December 19, 2025
• Study Completion: December 19, 2025
• Last Updated: February 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA PhRMA Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosuree.
• Access Criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Locations

ES (1)