At a glance
ClinicalIndex Comparison Record- ✓Histologically or cytologically confirmed advanced solid tumors
- ✓Germline and/or somatic mutation in BRCA1, BRCA2, PALB2, ATM, and/or CHEK2 (Phase I: any; Phase Ib Cohort A: germline; Phase Ib Cohort B: germline and/or somatic)
- ✓Measurable disease per RECIST 1.1
- ✓Age ≥18 years
- ✕Systemic anticancer therapies within 3 weeks, radiation within 2 weeks, antibody therapy within 4 weeks prior to first dose
- ✕Not recovered from prior anticancer therapy adverse events to ≤grade 1 (CTCAE v5.0) or baseline, other than alopecia
- ✕Receipt of other investigational agents or devices within 3 weeks
- ✕Unable to swallow oral medications
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase I/Ib Study of Olaparib and ASTX727 in BRCA1/2- and HRD-mutated Tumors
In Brief
A Phase 1 clinical trial evaluating Olaparib and ASTX727 for BRCA1 Mutation and 5 related conditions. Currently recruiting, targeting 18 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
Given orally
Given Orally