A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG.
| Condition(s) | Advanced or Metastatic Solid Tumors, Breast Cancer, Ovarian Cancer, Prostate Cancer, Epithelial Ovarian Cancer, BRCA2 Mutation, ER+ Breast Cancer, Castrate Resistant Prostate Cancer, BRCA1 Mutation, B |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | This is a two-part, open-label, multicenter, dose escalation and dose expansion study designed to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PDx), and anti- tumor activity of ETX-19477, a novel reversible small molecule inhibitor of PARG. |
| Who can participate | Inclusion Criteria: * Males and females of age ≥ 18 years at the time of signing the informed consent document. * Histologically or cytologically confirmed advanced (incurable recurrent, unresectable, or metastatic) solid cancer, excluding primary central nervous system (CNS) tumors. * Any solid tumor malignancy, excluding primary CNS tumors, with progression on or after or intolerance to most recent systemic therapy. Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function. * Measurable disease per RECIST v1.1. * ECOG performance status 0-1. * Progression on or after or intolerance to most recent systemic therapy. Prior treatment in the recurrent/metastatic setting; patients must have received approved standard therapy that i |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | 858 Therapeutics, Inc. |
| Locations | Phoenix, Arizona, United States; New Haven, Connecticut, United States; Jacksonville, Florida, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Rochester, Minnesota, United States (+8 more sites) |
| Start date | 2024-05-13 |
| NCT ID | NCT06395519 |
| Official listing | https://clinicaltrials.gov/study/NCT06395519 |