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NCT06177171
Olaparib and ASTX727 in BRCA1/2- and Homologous Recombination Deficient (HRD)-Mutated Tumors
Phase 1 trial testing Olaparib in BRCA1 Mutation in 18 participants. Currently enrolling.
31 January 2028
Quick facts
| Lead sponsor | Pamela Munster |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 18 |
| Start date | 7 February 2024 |
| Primary completion | 31 January 2028 |
| Estimated completion | 31 January 2028 |
| Sites | 1 location across United States |
Drugs / interventions tested
Conditions studied
- BRCA1 Mutation — all drugs for BRCA1 Mutation →
- BRCA2 Mutation — all drugs for BRCA2 Mutation →
- BRCA Mutation — all drugs for BRCA Mutation →
- PALB2 Gene Mutation — all drugs for PALB2 Gene Mutation →
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):
-
Epigenetic drugs in cancer therapy.
Suraweera A, O'Byrne KJ, Richard DJ. · · 2025 · cited 50× · PMID 40011240 · DOI 10.1007/s10555-025-10253-7 -
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 -
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 -
DNA methyltransferase inhibitors in oncology: clinical progress, limitations and future directions.
Michael DC, Mehdipour P. · · 2026 · PMID 41762718 · DOI 10.1080/17501911.2026.2637418 -
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:
- PubMed search for NCT06177171
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Olaparib
Trials testing the same drug.
- NCT05522491 — Olaparib in the Treatment of BRCA1/2 Unmutated and BRCA1 Promoter Methylated Recurrent and Metastatic Triple-negative Br · Phase 2 · not yet recruiting
- NCT05128734 — Temozolomide Monotherapy or in Combination With Olaparib in Patients With Triple Negative Breast Cancer (TNBC) · Phase 2 · not yet recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07407452 — Iparomlimab and Tuvonralimab (QL1706) Combined With Standard Chemotherapy or Combined With Intraperitoneal Perfusion Che · Phase 2 · not yet recruiting
- NCT06915025 — Phase 3 Trial Evaluating the Safety & Efficacy of IMNN-001 Administered in Combination w/ Standard NACT & Adjuvant Chemo · Phase 3 · recruiting
Other recruiting trials for BRCA1 Mutation
Currently open trials in the same condition.
- NCT06972719 — Hormone Replacement Therapy After Risk Reducing Salpingo-oophorectomy · NA · recruiting
- NCT07253051 — BRCA Mutation Carriers' Platform a Multicenter Study · recruiting
- NCT06201234 — Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+ · Phase 2 · recruiting
- NCT06488378 — Phase Ib Study of Axatilimab in Combination With Olaparib in BRCA1/2 and PALB2- Associated Metastatic HER2-negative Brea · Phase 1 · recruiting
- NCT05485766 — Novel Neoadjuvant and Adjuvant Strategy for Germline BRCA 1/2 Mutated Triple Negative Breast Cancer · Phase 2 · recruiting
Other Pamela Munster trials
Trials by the same sponsor.
- NCT05472220 — Alpelisib in Combination With Carboplatin in Patients With Solid Tumors and HPV-Positive Squamous Cell Carcinoma · Phase 1 · withdrawn
- NCT04498520 — Abexinostat, Palbociclib, and Fulvestrant for the Treatment of Breast or Gynecologic Cancer · Phase 1 · withdrawn
- NCT03318445 — Rucaparib and Irinotecan in Cancers With Mutations in DNA Repair · Phase 1 · completed
- NCT02620839 — Phase Ib Study of Alpelisib With Cisplatin in Patients With HPV+ Solid Tumor Malignancies · Phase 1 · terminated
- NCT02358200 — Study of BMN-673 With Carboplatin and Paclitaxel in Patients With Advanced BRCA-mutated Solid Tumor or Triple Negative M · Phase 1 · terminated
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06177171 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Pamela Munster
- Last refreshed: 2 February 2026
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