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New drug MDX2004 targets advanced tumors in early trial

NCT ID NCT07110584

Disease control Sponsor: ModeX Therapeutics, An OPKO Health Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug, MDX2004, in 235 adults with advanced solid tumors that have spread or cannot be removed. The main goals are to check safety, find the best dose, and see if the drug can shrink tumors. Participants must be 18 or older, in good daily function, and have at least one measurable tumor.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 235 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2025

Expected to finish

Jun 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced tumors

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    6 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Calvary Mater Newcastle

    RECRUITING

    Waratah, New South Wales, 2298, Australia

    Contact Email: •••••@•••••

  • Hadassah University Hospital-Ein Kerem

    RECRUITING

    Jerusalem, 9574409, Israel

    Contact Email: •••••@•••••

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

    Contact Email: •••••@•••••

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

    Contact Email: •••••@•••••

  • Rambam Health Care Campus

    RECRUITING

    Haifa, 3109601, Israel

    Contact Email: •••••@•••••

  • Tel Aviv Sourasky Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

    Contact Email: •••••@•••••

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