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FORX-428 for Advanced Solid Tumors

This study is testing a new oral medication called FORX-428 for people with advanced solid tumors. You might be able to join if your cancer has specific genetic changes (like BRCA1/2 mutations) or other issues with DNA repair or high replication stress. To join, you must be at least 18 years old and have already received at least one standard treatment for your advanced or metastatic cancer that didn't work well enough. The main goals are to find a safe dose of FORX-428 and see how well it is tolerated. Researchers will also look for early signs that the drug might be effective against cancer. This study is for people whose cancer has progressed after previous treatments.

Study design
This is an interventional study with a planned enrollment of 40 participants. It will test different doses of FORX-428 given as a single treatment.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety and side effects will be measured for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07356453

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
FoRx Therapeutics AG
~40 participants
Updated 2026-01-21 on ClinicalTrials.gov
What's tested:FORX-428

At a glance

Recruiting sites
8 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs)
Measured over 1 year.
+10 more outcomes measured

Conditions

Advanced Solid Tumors

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Where it's being run

8 sites across 6 states
California2
Texas2
Michigan1
Missouri1
Oregon1
Virginia1

Who to contact

Jens Wuerthner, MD, PhD
[email protected]
+1 513-579-9911
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Platelet count \>/=100 × 10\^9/L (\>/=100,000/μL) (absence of platelet transfusion within 1 week);
Hemoglobin \>/=90 g/L (\>/=5.6 mmol/L) (absence of red blood cell transfusion within 2 weeks);
Absolute neutrophil count \>/=1.5 × 10\^9/L (\>/=1500/μL) (absence of growth factors within 2 weeks);
Aspartate aminotransferase and alanine aminotransferase \</=2.5 × upper limit normal (ULN) or \</=5 × ULN for patients with liver metastases;
Total bilirubin \</=1.5 × ULN, or \</=3.0 × ULN for patients with liver metastases or Gilbert's syndrome;
Estimated glomerular filtration rate \>/=60 mL/min calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration Equation; and
Adequate coagulation test results defined by activated partial thromboplastin time \</=1.5 × ULN, international normalized ratio (INR) \</=2.0 with the exception of INR 2 to 3 acceptable for patients on warfarin anticoagulation or direct oral anticoagulants. 7. Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 with \>/=3 months of life expectancy for Dose Escalation cohorts, and an ECOG PS of 0 to 1 with \>/=3 months of life expectancy for backfilling and Dose Expansion cohorts; 8. Patient is able to swallow tablets and has no gastrointestinal conditions affecting absorption.

What this trial measures

  • Dose Escalation Phase: Incidence of Dose-Limiting Toxicities (DLTs)1 year.
  • Dose Escalation Phase: Incidence of treatment-emergent serious adverse events (TESAEs)1 year.
  • Dose Escalation Phase: Incidence and severity of Treatment-emergent adverse event (TEAEs) and laboratory abnormalities1 year.

    Adverse events will be recorded and severity graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

  • Dose Escalation Phase: Incidence of treatment discontinuations and treatment modifications due to adverse events (AEs) and laboratory abnormalities1 year.
  • Dose Escalation Phase: Change in vital signs measurements, clinical laboratory assessment, 12-lead electrocardiograms (ECGs), physical examinations (including Eastern Cooperative Oncology Group [ECOG] Performance Status [PS]), and urinalyses1 year.
  • Dose Escalation Phase: Establishing the Maximum Tolerated Dose (MTD) and Recommended Cohort Expansion Dose (RCED) of FORX-428 administered as monotherapy1 year.
  • Dose Expansion Phase: Tumor response: Best Overall Response (BOR)1 year.

    BOR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Dose Expansion Phase: Tumor response: Overall Response Rate (ORR)1 year.

    ORR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Dose Expansion Phase: Tumor response: Disease Control Rate (DCR)1 year.

    DCR will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Dose Expansion Phase: Tumor response: Progression-free Survival (PFS)1 year.

    PFS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

  • Dose Expansion Phase: Tumor response: Overall Survival (OS)1 year.

    OS will be measured according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1