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NCT06177171

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

Recruiting now Phase 1 Last updated 2 February 2026
What this trial tests

Phase 1 trial testing Olaparib in BRCA1 Mutation in 18 participants. Currently enrolling.

Timeline
7 February 2024
Primary endpoint
31 January 2028
31 January 2028

Quick facts

Lead sponsorPamela Munster
PhasePhase 1
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationnon randomized
Designsequential
Maskingnone
Primary purposetreatment
Enrollment18
Start date7 February 2024
Primary completion31 January 2028
Estimated completion31 January 2028
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pamela Munster — full company profile →

Who can join

18 and older, any sex, with BRCA1 Mutation or BRCA2 Mutation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Epigenetic drugs in cancer therapy.
    Suraweera A, O'Byrne KJ, Richard DJ. · · 2025 · cited 50× · PMID 40011240 · DOI 10.1007/s10555-025-10253-7
  2. Germline Genetic Mutations in Adult Patients with Sarcoma: Insight into the Middle East Genetic Landscape.
    Abu-Hijlih R, Sharaf B, Salah S, Bani Hani H, et al · · 2024 · cited 2× · PMID 38730621 · DOI 10.3390/cancers16091668
  3. A phase 1 study of ASTX727 plus talazoparib in patients with triple-negative or hormone resistant/HER2-negative metastatic breast cancer.
    Miller KD, Thomas A, Althouse S, Zang Y, et al · · 2026 · PMID 41980055 · DOI 10.1002/cncr.70407
  4. DNA methyltransferase inhibitors in oncology: clinical progress, limitations and future directions.
    Michael DC, Mehdipour P. · · 2026 · PMID 41762718 · DOI 10.1080/17501911.2026.2637418
  5. Antitumor activity and structure-activity relationship of poly (ADP-ribose) polymerase (PARP)-based dual inhibitors.
    Yang C, Shang Y, Li X, Li J, et al · · 2026 · PMID 41395847 · DOI 10.1080/14756366.2025.2598478

Verify or expand the search:

Other trials of Olaparib

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06177171.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing