Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors

Recruiting now · Phase 1/Phase 2

Conditions studied: Advanced Tumors

In brief

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.

Key facts

Study ID

NCT07110584

Run by

ModeX Therapeutics, An OPKO Health Company

People needed

235

Starts

2025-10-01

Expected to finish

2031-06-30

Last updated by the study team

2026-03-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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