RecruitingPhase 1Phase 2NCT06395519

A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies

Sponsor

858 Therapeutics, Inc.

Enrollment

120 participants

Start Date

May 13, 2024

Study Type

INTERVENTIONAL

Conditions

Breast Cancer Ovarian Cancer Endometrial Cancer Prostate Cancer BRCA Mutation ER+ Breast Cancer BRCA1 Mutation BRCA2 Mutation Advanced or Metastatic Solid Tumors Epithelial Ovarian Cancer Castrate Resistant Prostate Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study tests a new experimental drug called ETX-19477 — which works by blocking a DNA repair protein called PARG — in patients with advanced solid tumors, particularly those with certain genetic mutations that make cancer cells more vulnerable to DNA damage. **You may be eligible if...** - You have an advanced solid tumor that has not responded to standard treatments - Your tumor may have specific DNA repair gene mutations (such as BRCA1/2 or others) - You are at least 18 years old with adequate organ function - You are willing to undergo tumor biopsies as required by the study **You may NOT be eligible if...** - You have active brain metastases requiring treatment - You have had prior treatment with a PARG or PARP inhibitor (depending on study arm) - You have serious infections or autoimmune conditions - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGETX-19477

Oral medication taken daily

Locations(14)

Mayo Clinic

Phoenix, Arizona, United States

Yale University, Yale Cancer Center

New Haven, Connecticut, United States

Mayo Clinic

Jacksonville, Florida, United States

University of Chicago Medical Center

Chicago, Illinois, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

Laura & Isaac Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States

Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

START Center for Cancer Care - Mountain Region

Salt Lake City, Utah, United States

Virginia Cancer Specialists

Fairfax, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

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NCT06395519

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