A Master Protocol Phase I/II Study to Investigate Biomarker-Guided Novel Anticancer Agent(s) as Monotherapy or Combination Therapy for the Treatment of Participants With Advanced/Recurrent Ovarian Cancer (Ovarian Platform)
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.
⁃ 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.