New daily pill hopes to control advanced cancers
NCT ID NCT06395519
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial is testing a new daily oral medication called ETX-19477 in about 120 adults with advanced solid tumors, including breast, ovarian, prostate, and other cancers. The drug blocks a protein called PARG to interfere with cancer cells' ability to repair themselves. The main goals are to find a safe dose and see if the drug can help control tumor growth.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ETX-19477 (a daily oral pill that blocks a protein called PARG to potentially stop cancer cells from repairing themselves)
- What this could lead to
- If this works, it could offer a new daily treatment option for people with advanced solid tumors, especially those with BRCA mutations, helping to control their cancer.
- What could go wrong
- This is an early Phase 1/2 trial with only 120 participants, so it's too soon to know if the drug is effective. It may cause side effects or fail to shrink tumors.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
14 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fred Hutchinson Cancer Center
RECRUITINGSeattle, Washington, 98109, United States
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Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
RECRUITINGNew York, New York, 10016, United States
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MD Anderson Cancer Center
RECRUITINGHouston, Texas, 77030, United States
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Massachusetts General Hospital
RECRUITINGBoston, Massachusetts, 02114, United States
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Mayo Clinic
RECRUITINGPhoenix, Arizona, 85054, United States
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Mayo Clinic
RECRUITINGJacksonville, Florida, 32224, United States
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Mayo Clinic
RECRUITINGRochester, Minnesota, 55905, United States
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Memorial Sloan Kettering Cancer Center
RECRUITINGNew York, New York, 10065, United States
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START Center for Cancer Care - Mountain Region
RECRUITINGSalt Lake City, Utah, 84112, United States
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Stefanie Spielman Comprehensive Breast Center
RECRUITINGColumbus, Ohio, 43212, United States
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Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
RECRUITINGPhiladelphia, Pennsylvania, 19107, United States
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University of Chicago Medical Center
RECRUITINGChicago, Illinois, 60637, United States
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Virginia Cancer Specialists
RECRUITINGFairfax, Virginia, 22031, United States
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Yale University, Yale Cancer Center
RECRUITINGNew Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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- Can a Patient's own immune cells fight ovarian cancer?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- Ovarian Cancer's spread: scientists probe abdominal fluid for clues
- A scanner in the operating room could show surgeons exactly where prostate cancer remains
- New PET tracer aims to light up hidden cancer targets