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Clinical Trials in Australia / NCT07110584
Recruiting Phase 1/2

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

NCT07110584 · tracked via the Priya Life Science Australia tracker
Phase
Phase 1/2
Started
2025-10-01
Last updated
2026-03-05

Condition(s) studied

Advanced Tumors

Investigational drug(s) / intervention(s)

MDX2004

MDX2004: MDX2004 intravenous infusion

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Liverpool Hospital Liverpool New South Wales Recruiting
Calvary Mater Newcastle Waratah New South Wales Recruiting
Princess Alexandra Hospital Woolloongabba Queensland 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

More ModeX Therapeutics, An OPKO Health Company trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07110584 on ClinicalTrials.gov ↗ ← All trials in Australia