A Study of ETX-19477 for Advanced Solid Tumors
This study is testing a new oral medication called ETX-19477 for people with advanced solid cancers, including breast, ovarian, and prostate cancer. The medication works by targeting a protein called PARG, which plays a role in how cancer cells repair their DNA. Researchers want to see how safe ETX-19477 is and what dose works best. They will also look at how your body handles the drug and if it helps shrink tumors. You may be able to join if you are at least 18 years old and have an advanced solid cancer that has spread or come back. The study is currently unclear on its recruitment status.
- Study design
- This is an open-label study, meaning you and your doctors will know you are receiving ETX-19477. It will involve about 120 participants and has two parts: one to find the right dose and another to expand on those findings.
- What's involved
- You would take the oral medication ETX-19477 daily. The study will assess safety and tolerability, and determine the maximum tolerated dose or recommended dose within 6 months.
- Compensation
- Not stated in the trial record.
- Follow-up
- The primary endpoints for safety and tolerability, and the maximum tolerated dose, are measured at 6 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06395519
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
Recruiting
PHASE1Ages 18+InterventionalTreatment858 Therapeutics, Inc.
~120 participants
Updated 2026-03-27 on ClinicalTrials.gov
What's tested:ETX-19477
At a glance
Recruiting sites
14 of 14 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To characterize the safety and tolerability of ETX-19477, the maximum tolerated dose (MTD) and/or RP2D of ETX-19477
Measured over 6 months
Conditions
Where it's being run
14 sites across 13 statesNew York2
Arizona1
Connecticut1
Florida1
Illinois1
Massachusetts1
Minnesota1
Ohio1
Study leadership
- Daniel McCormick · STUDY_DIRECTOR · 858 Therapeutics, Inc.
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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 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.
No investigational agent within 3 weeks or 5 half-lives (whichever is shorter; minimum of 2 weeks) prior to first dose of study drug.
Life expectancy of at least 3 months.
Exclusion
Receiving continuous corticosteroids at prednisone-equivalent dose of \>10 mg/day. Chronic systemic corticosteroid therapy for physiologic replacement (≤10 mg/day of prednisone equivalents) and the use of non-systemic corticosteroids (e.g., inhaled, topical, intra-nasal, intra-articular, or ophthalmic) are permitted.
Definitive radiotherapy within 6 weeks and palliative radiation within 2 weeks prior to the first dose of study drug.
Symptomatic untreated or progressing brain metastases. Stable, treated brain metastases are allowed if no evidence of radiologic or clinical progression or increasing corticosteroid use for at least 4 weeks.
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.
Known symptomatic and radiologically progressing or leptomeningeal disease (LMD). If LMD has been reported radiographically on baseline magnetic resonance imaging (MRI), but is not suspected clinically by the Investigator, the patient must be free of neurological symptoms of LMD.
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.
Known active or chronic infection (viral, bacterial, or fungal), including tuberculosis, hepatitis B, hepatitis C, or AIDS-related illness. Controlled infections, including HIV and "cured" hepatitis C (no active fever, no evidence of systemic inflammatory response syndrome) that are stable with undetectable viral load on antiviral treatment are not exclusionary.
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).
Known other previous/current malignancy requiring treatment within ≤2 years except for limited disease treated with curative intent, such as carcinoma in situ, squamous or basal cell skin carcinoma, or superficial bladder carcinoma and not requiring ongoing chemotherapy.
Patients receiving proton pump inhibitors (PPIs), strong cytochrome P450 (CYP)3A inhibitors and inducers, or P-glycoprotein (P-gp) inhibitors. Patients should not receive PPIs within 7 days prior to first dose of study drug. Strong CYP3A inducers or inhibitors or strong P-gp inhibitors should not be given within 6 half-lives prior to first dose of study drug.
Patients currently treated with therapeutic doses of warfarin sodium (Coumadin®) or any other coumarin-derivative anticoagulants
What this trial measures
- To characterize the safety and tolerability of ETX-19477, the maximum tolerated dose (MTD) and/or RP2D of ETX-194776 months
Frequency of dose-limiting toxicities (DLTs), frequency and severity of AEs, including abnormal ECG parameters, and serious adverse events (SAEs)