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NCT06395519 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer and Prostate Cancer, sponsored by 858 Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
120
Enrollment target
12
Study locations

NCT06395519 is a Phase 1 study of Breast Cancer and Prostate Cancer that is actively recruiting participants, run by 858 Therapeutics. The registered enrollment target is 120 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 12 study locations across 11 states.

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The verdict

NCT06395519, a Phase 1 study of Breast Cancer and Prostate Cancer, is actively recruiting participants, sponsored by 858 Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
120 participants
Enrollment target
12
Study locations

Study 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.

Conditions Studied

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

Interventions

  • DRUG ETX-19477

Study Locations (12)

New York

  • Laura & Isaac Perlmutter Cancer Center at NYU Langone Health - New York
  • Memorial Sloan Kettering Cancer Center - New York

Arizona

  • Mayo Clinic - Phoenix

Connecticut

  • Yale University, Yale Cancer Center - New Haven

Florida

  • Mayo Clinic - Jacksonville

Massachusetts

  • Massachusetts General Hospital - Boston

Minnesota

  • Mayo Clinic - Rochester

Pennsylvania

  • Thomas Jefferson University, Sidney Kimmel Comprehensive Cancer Center - Philadelphia

Texas

  • MD Anderson Cancer Center - Houston

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2024-05-13
Est. Completion 2026-12
Phase Phase 1

Sponsor

858 Therapeutics

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06395519

The ClinicalTrials.gov registry entry for NCT06395519 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The listed sponsor is 858 Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which ETX-19477 is the first listed.

NCT06395519 reports 12 study locations spanning 11 distinct geographic areas - top geographies include New York, Arizona, Connecticut.

Frequently Asked Questions

What is clinical trial NCT06395519 about?

NCT06395519 is a clinical study titled "A Study of PARG Inhibitor ETX-19477 in Patients With Advanced Solid Malignancies". 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.

What is the current status of trial NCT06395519?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2024-05-13. Estimated completion is 2026-12.

What conditions does trial NCT06395519 study?

This clinical trial studies the following conditions: Breast Cancer, Prostate Cancer, Ovarian Cancer, Epithelial Ovarian Cancer, Advanced or Metastatic Solid Tumors.

What interventions are being tested in trial NCT06395519?

The interventions under investigation include: ETX-19477 (DRUG).

Who is sponsoring clinical trial NCT06395519?

This trial is sponsored by 858 Therapeutics, which has 1 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06395519 being conducted?

This trial has 12 study locations across Arizona, Connecticut, Florida, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.