Clinical trialPhase 2Not yet recruiting
Saruparib in HRDsig+ Solid Tumors
A Phase II Study of Saruparib in Patients With Platinum-Sensitive, HRDsig+ Solid Tumors
- Outcome
- Ongoing
- Phase
- Phase 2
- Status
- Not yet recruiting
- Study type
- Interventional
- Start
- 1 November 2026
- Expected end
- 1 November 2030
- Enrollment
- 124 participants
- Sites
- 1
- Primary outcomes
- Best objective response as determined by RECIST v.1.1
- Sponsor type
- Academic / other
- Results posted
- No
- Last update
- 2 November 2026
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Brief summary public domain (ClinicalTrials.gov)
The main purpose of this study is to study the effect of saruparib, an experimental PARP inhibitor, on tumors that have an Homologous Recombination Deficiency Signature (HRDsig) positive tumor by the investigational FoundationOne®CDx clinical trial assay.
Detailed description public domain (ClinicalTrials.gov)
This is an open-label, phase II study of saruparib in patients with locally advanced or metastatic solid tumors that are HRDsig+ by FoundationOneCDx (Foundation Medicine, Inc). Patients in Cohort A must also have a pathogenic germline or somatic variant in BRCA1, BRCA2, PALB2, RAD51B, RAD51C, RAD51D or BARD1. The primary endpoint is overall response rate in Cohort A.