Phase 2 study

Recruiting Phase 2

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Phase 2
Sponsor ModeX Therapeutics, An OPKO Health Company
Registry number NCT07110584
Started 1 October 2025 Today 16 October 2026 Estimated completion 30 June 2031

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
Liverpool Hospital Liverpool NSW Recruiting
Calvary Mater Newcastle Waratah NSW Recruiting
Princess Alexandra Hospital Woolloongabba QLD Recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years and over
Sex Anyone, regardless of sex
Healthy volunteers Not accepted
Enrolment target 235

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

Inclusion Criteria:

* Participant must be ≥ 18 years of age.

* Histologically or cytologically confirmed diagnosis of locally advanced or metastatic malignancy.

* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

* All participants should have at least 1 measurable site of disease according to RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.

* Adequate hematologic, hepatic and renal function.

* All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

* Capable of giving signed informed consent.

Exclusion Criteria:

* Any clinically significant cardiac disease.

* Unresolved toxicities from previous anticancer therapy.

* Known untreated, active, or uncontrolled brain metastases.

* Previous Grade 3 or 4 immune-related toxicity that led to the discontinuation of treatment, within 6 months prior to the first dose of MDX2004.

* Active medical condition requiring chronic systemic steroid use (\>10 mg/day prednisone or equivalent) or immunosuppressive therapy, within 6 months prior to the first dose of MDX2004.

* Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infection requiring intravenous treatment.

* Prior solid organ or hematologic transplant

* Require supplemental oxygen for activities of daily living

* Participant is not suitable for participation, whatever the reason, as judged by the Investigator including medical or clinical conditions.

Dates on the record

Started 1 October 2025
Estimated completion 30 June 2031
Registry last updated 5 March 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 5 March 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.