18 and older, female only, with Gynecologic Neoplasms or Epithelial Ovarian Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Phase 1b (PLX2853 + Carboplatin Combination): Establish the Number of Participants Reaching MTD/RP2D for the Combination of PLX2853 and CarboplatinPrimary· From time of first dose of PLX2853 and carboplatin until 30 days of end of treatment an average of 6 months.
MTD is defined as the maximum tolerated dose, which is determined from dose-limiting toxicity. If DLTs are observed in 2 or more of 6 subjects (or ≥33% of the cohort) at a dose level, the dose at which this occurs will be considered intolerable and the MTD will have been exceeded. The MTD is the dose below the intolerable dose.
RP2D is the recommended Phase 2 dose, which was determined to be 80 mg
Time frame: Through 30 days after last dose of study drug, an average of 6 months.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this research study is to evaluate safety, pharmacokinetics, pharmacodynamics and preliminary efficacy of the investigational drug PLX2853 in Advanced Gynecological Malignancies with a Known ARID1A Mutation and PLX2853/Carboplatin Combination Therapy in Platinum-Resistant Epithelial Ovarian Cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03787498 — A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
· Phase 1
· completed
NCT03297424 — A Study of PLX2853 in Advanced Malignancies.
· Phase 1
· completed
Other recruiting trials for Gynecologic Neoplasms
Currently open trials in the same condition.
NCT05185947 — Study of Intravenous and Intraperitoneal Paclitaxel and Oral Nilotinib for Peritoneal Carcinomatosis From Colorectal, Ap
· Phase 2
· active not recruiting
Other Opna Bio LLC trials
Trials by the same sponsor.
NCT04556617 — PLX2853 in Combination With Abiraterone Acetate and Prednisone and in Combination With Olaparib in Subjects With Metasta
· Phase 1, PHASE2
· terminated
NCT03787498 — A Study of PLX2853 in Relapsed or Refractory Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
· Phase 1
· completed
NCT03297424 — A Study of PLX2853 in Advanced Malignancies.
· Phase 1
· completed
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 Opna Bio LLC
Last refreshed: 4 November 2024
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/NCT04493619.