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NCT07356453 · ClinicalTrials.gov registry record · Phase 1

A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.

A Phase 1 study of Advanced Solid Tumors, sponsored by FoRx Therapeutics.

Recruiting
Registry status
Phase 1
Development phase
40
Enrollment target
8
Study locations

NCT07356453 is a Phase 1 study of Advanced Solid Tumors that is actively recruiting participants, run by FoRx Therapeutics. The registered enrollment target is 40 participants, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (80% lower). The trial reports 8 study locations across 6 states.

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The verdict

NCT07356453, a Phase 1 study of Advanced Solid Tumors, is actively recruiting participants, sponsored by FoRx Therapeutics.

RECRUITING
Registry status
Phase 1
Development phase
40 participants
Enrollment target
8
Study locations

Study Summary

The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-48 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 as monotherapy.

Conditions Studied

Advanced Solid Tumors

Interventions

  • DRUG FORX-428

Study Locations (8)

California

  • Stanford University Medical Center - Palo Alto
  • University of California, San Francisco - San Francisco

Texas

  • University of Texas - MD Anderson Cancer Center - Houston
  • START - San Antonio - San Antonio

Michigan

  • START - Midwest - Grand Rapids

Missouri

  • Washington University St. Louis - St Louis

Oregon

  • Knight Cancer Institute - Portland

Virginia

  • NEXT - Virginia Cancer Specialists - Fairfax

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2025-07-22
Est. Completion 2028-04
Phase Phase 1

Sponsor

FoRx Therapeutics

1 total trials

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What the Registry Record Tells You About NCT07356453

The ClinicalTrials.gov registry entry for NCT07356453 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 198-participant average among 144 other Advanced Solid Tumors trials with a reported enrollment target (80% lower). The listed sponsor is FoRx Therapeutics, which has 1 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Advanced Solid Tumors appearing as the primary indexed condition, and to 1 intervention - of which FORX-428 is the first listed.

NCT07356453 reports 8 study locations spanning 6 distinct geographic areas - top geographies include California, Texas, Michigan.

Frequently Asked Questions

What is clinical trial NCT07356453 about?

NCT07356453 is a clinical study titled "A Study of PARG Inhibitor FORX-428 in Patients With Advanced Solid Tumors.". The goal of this interventional study is to evaluate the safety and tolerability of escalating doses of FORX-48 as monotherapy in patients with select advanced solid tumors with BRCA1/2 mutations or other DDR deficiencies or high replication stress, and to determine the maximum tolerated dose (MTD) ...

What is the current status of trial NCT07356453?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2025-07-22. Estimated completion is 2028-04.

What conditions does trial NCT07356453 study?

This clinical trial studies the following conditions: Advanced Solid Tumors.

What interventions are being tested in trial NCT07356453?

The interventions under investigation include: FORX-428 (DRUG).

Who is sponsoring clinical trial NCT07356453?

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

Where is trial NCT07356453 being conducted?

This trial has 8 study locations across California, Michigan, Missouri, Oregon, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.