Testing MDX2004 at increasing doses in adults with advanced tumors

A Phase 1/2, Multi-Center, Open-Label Clinical Study Evaluating MDX2004 In Participants With Advanced Tumors

This will test whether different doses of the experimental drug MDX2004 are safe and can shrink tumors in adults with advanced or metastatic cancer.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 235 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: ModeX Therapeutics, An OPKO Health Company (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 6 sites (Liverpool, New South Wales and 5 other locations)
• Trial ID: NCT07110584 on ClinicalTrials.gov

What this trial studies

This Phase 1/2 program uses a dose-escalation phase to identify a tolerable dose of MDX2004 followed by a dose-expansion phase to gather additional safety and anti-tumor activity data. Eligible adults must have histologically confirmed locally advanced or metastatic malignancy, ECOG performance status 0–1, measurable disease per RECIST v1.1, and adequate organ function. Key exclusions include significant cardiac disease, unresolved toxicities from prior anticancer therapy, active untreated brain metastases, and prior severe immune-related toxicity that caused treatment discontinuation. Participants will receive MDX2004 and be monitored for adverse events, laboratory changes, and tumor response.

Who should consider this trial

Good fit: Adults aged 18 or older with histologically or cytologically confirmed locally advanced or metastatic malignancy, ECOG 0–1, at least one measurable lesion, and adequate hematologic, hepatic, and renal function are candidates.

Not a fit: Patients with uncontrolled or untreated brain metastases, clinically significant cardiac disease, unresolved toxicities from prior therapy, or prior grade 3–4 immune-related toxicity leading to treatment stop are unlikely to be eligible or benefit.

Why it matters

Potential benefit: If effective, MDX2004 could provide tumor control or clinical benefit for some patients with advanced cancers who have limited treatment options.

How similar studies have performed: Dose-escalation followed by expansion is a common approach and similar investigational anti-cancer agents have shown activity in some tumor types, but MDX2004 itself is investigational and unproven.

Eligibility criteria

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.

Where this trial is running

Liverpool, New South Wales and 5 other locations

• Liverpool Hospital — Liverpool, New South Wales, Australia (Recruiting)
• Calvary Mater Newcastle — Waratah, New South Wales, Australia (Recruiting)
• Princess Alexandra Hospital — Woolloongabba, Queensland, Australia (Recruiting)
• Rambam Health Care Campus — Haifa, Israel (Recruiting)
• Hadassah University Hospital-Ein Kerem — Jerusalem, Israel (Recruiting)
• Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Recruiting)

Study contacts

• Study coordinator: ModeX Therapeutics, An OPKO Health Company

Conditions Advanced Tumors