drugset / Trial / NCT06177171

Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors

NCT06177171

Non-randomizedSequentialOpen-labelTreatment

Summary

This is a single center, phase I/Ib clinical trial evaluating the combination of the poly adenosine diphosphate-ribose polymerase (PARP) inhibitor olaparib with the DNA methyltransferase (DNMT) inhibitor ASTX727, which is an oral formulation of decitabine with cedazuridine (a cytidine deaminase inhibitor that allows for oral administration). The study population consists of adults with advanced/metastatic solid tumor malignancies with germline or somatic mutations in the HRR pathway (i.e., BReast CAncer gene 1 (BRCA1), BReast CAncer gene 2(BRCA2), Partner And Localizer of BRCA2 (PALB2), ATM, and/or Checkpoint kinase 2 (CHEK2) mutations).

Timeline

Start
2024-02-07
Primary completion
2028-01-31
Completion
2028-01-31

Drugs

EvaluationDrugModalityDoseRoute
Subject ASTX727 Unknown 35 mg Oral
Subject ASTX727 Unknown 100 mg Oral
Subject Olaparib Small molecule 300 mg Oral