Actively Recruiting
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
Led by 858 Therapeutics, Inc. · Updated on 2026-03-27
120
Participants Needed
14
Research Sites
133 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Males and females aged 18 years or older at the time of signing informed consent
- Histologically or cytologically confirmed advanced solid cancer excluding primary central nervous system tumors
- Solid tumor malignancy with progression after or intolerance to recent systemic therapy
- Preferential enrollment for patients with known BRCA2 loss-of-function mutations
- Measurable disease according to RECIST v1.1
- ECOG performance status of 0 or 1
- Prior treatment in recurrent/metastatic setting with available approved standard therapy unless contraindicated, intolerable, or declined
- No investigational agents within 3 weeks or 5 half-lives (minimum 2 weeks) before first dose
- Life expectancy of at least 3 months
You will not qualify if you...
- Receiving continuous corticosteroids at prednisone-equivalent dose greater than 10 mg/day
- Definitive radiotherapy within 6 weeks or palliative radiation within 2 weeks before first dose
- Symptomatic untreated or progressing brain metastases; stable treated brain metastases allowed if no progression or increased corticosteroid use for at least 4 weeks
- Gastrointestinal impairment or disease affecting absorption of ETX-19477, no bowel obstruction within 6 months or peritoneal fluid drainage within 8 weeks prior to first dose
- Known symptomatic and progressing or leptomeningeal disease unless no neurological symptoms present
- Resting ECG QTcF greater than 470 msec on 2 or more timepoints or history/family history of long QT syndrome or use of QT prolonging meds
- History of myocardial infarction or unstable angina within 6 months, clinically significant cardiac disease
- Active or chronic infections including tuberculosis, hepatitis B or C, AIDS-related illness; controlled infections with stable viral load are allowed
- Acute or chronic uncontrolled renal disease, pancreatitis, or liver disease except stable chronic liver disease
- Other malignancies requiring treatment within 2 years except certain limited diseases treated with curative intent
- Use of proton pump inhibitors within 7 days, strong CYP3A or P-gp inhibitors or inducers within 6 half-lives prior to first dose
- Current therapeutic use of warfarin sodium or other coumarin-derivative anticoagulants
AI-Screening
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Trial Site Locations
Total: 14 locations
1
Mayo Clinic
Phoenix, Arizona, United States, 85054
Actively Recruiting
2
Yale University, Yale Cancer Center
New Haven, Connecticut, United States, 06510
Actively Recruiting
3
Mayo Clinic
Jacksonville, Florida, United States, 32224
Actively Recruiting
4
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
5
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
6
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
7
Laura & Isaac Perlmutter Cancer Center at NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
8
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
9
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, United States, 43212
Actively Recruiting
10
Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
11
MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
12
START Center for Cancer Care - Mountain Region
Salt Lake City, Utah, United States, 84112
Actively Recruiting
13
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Actively Recruiting
14
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
Research Team
8
858 Therapeutics, Inc.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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