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

NCT07356453 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-21

No results posted yet for this 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

Interventions

DRUG

FORX-428

FORX-428 drug product is formulated as immediate release tablets for oral administration in 3 dosage strengths containing 10 mg, 50 mg, and 100 mg FORX-428 drug substance.

Sponsors & Collaborators

  • FoRx Therapeutics AG

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-22
Primary Completion
2027-06-30
Completion
2028-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07356453 on ClinicalTrials.gov