Actively Recruiting
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
Led by Pamela Munster · Updated on 2026-02-02
18
Participants Needed
1
Research Sites
207 weeks
Total Duration
On this page
Sponsors
P
Pamela Munster
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Histologically or cytologically confirmed advanced solid tumors with germline and/or somatic mutation in BRCA1, BRCA2, PALB2, ATM, and/or CHEK2 genes
- Measurable disease according to RECIST 1.1 criteria
- Refractory or intolerant to or unwilling to receive currently approved therapies
- Prior PARP inhibitor treatment allowed if no dose reductions, delays, or allergic reactions occurred
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2 or Karnofsky score greater than 60%
- Adequate bone marrow, liver, and kidney function as specified
- Ability to understand and willing to sign informed consent
- HIV-infected individuals on effective therapy with undetectable viral load within 6 months
- Chronic hepatitis B infection with undetectable viral load on therapy
- Treated and cured hepatitis C infection or currently treated with undetectable viral load
- Treated brain metastases with no progression for at least 4 weeks and no steroid treatment for at least 14 days prior to treatment
- Agree to use adequate contraception if of childbearing potential and for required duration after treatment
- Prior or concurrent malignancy allowed if it does not interfere with safety or efficacy assessment
You will not qualify if you...
- Received systemic anticancer therapies within 3 weeks, radiation within 2 weeks, or antibody therapy within 4 weeks prior to study
- Not recovered from prior therapy adverse events to grade 1 or baseline except alopecia
- Received other investigational agents or devices within 3 weeks prior to trial
- Unable to swallow oral medications
- Currently breastfeeding or chest-feeding
- Pregnant or positive pregnancy test within 72 hours prior to first dose
- Diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
- Taking prohibited medications that cannot be safely discontinued or substituted
- Any condition or circumstance that impairs ability to comply with study or safety as judged by investigator
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of California, San Francisco
San Francisco, California, United States, 94143
Actively Recruiting
Research Team
E
Early Phase Cancer Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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