OncoMatch/Clinical Trials/NCT06395519
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
Is NCT06395519 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies ETX-19477 for advanced or metastatic solid tumors.
Treatment: ETX-19477 — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Tumor Agnostic
Breast Carcinoma
Ovarian Cancer
Prostate Cancer
Endometrial Cancer
Colorectal Cancer
Gastric Cancer
Biomarker criteria
Allowed: BRCA2 mutation resulting in loss of function
Preferential enrollment consideration will be made for patients with known BRCA2 mutations resulting in loss of function.
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: systemic therapy — recurrent/metastatic
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 is available to the patient that is known to confer clinical benefit, unless this therapy is contraindicated, intolerable to the patient, or is declined by the patient.
Cannot have received: investigational agent
No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.
Cannot have received: definitive radiotherapy
Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.
Lab requirements
Kidney function
No acute or chronic uncontrolled renal disease.
Liver function
No acute or chronic uncontrolled liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment).
Cardiac function
No history of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure. Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) >470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT/QTc interval, or history of additional risk factors for torsades de pointes (Tdp).
Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of ETX-19477 and no history of bowel obstruction within 6 months and/or peritoneal fluid drainage within 8 weeks prior to the first dose of study drug. Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease (with exception of patients with Gilbert's Syndrome, asymptomatic gallstones, liver metastases, or stable chronic liver disease per Investigator assessment). Resting ECG with QT interval calculated using the Fridericia's formula (QTcF) >470 msec on 2 or more timepoints within a 24-hour period, or history or family history of congenital long QT syndrome, or taking concomitant medications that are known to prolong the QT/QTc interval, or history of additional risk factors for torsades de pointes (Tdp). History of myocardial infarction or unstable angina within 6 months prior to enrollment, or clinically significant cardiac disease, such as ventricular arrhythmia requiring therapy, uncontrolled hypertension, clinically significant uncontrolled arrhythmias, or any history of symptomatic congestive heart failure.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mayo Clinic · Phoenix, Arizona
- Yale University, Yale Cancer Center · New Haven, Connecticut
- Mayo Clinic · Jacksonville, Florida
- University of Chicago Medical Center · Chicago, Illinois
- Massachusetts General Hospital · Boston, Massachusetts
Showing up to 5 US sites. See all sites on ClinicalTrials.gov →
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