Actively Recruiting
Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-03-05
235
Participants Needed
6
Research Sites
299 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
CONDITIONS
Official Title
Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older
- Confirmed diagnosis of locally advanced or metastatic malignancy by histology or cytology
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- At least one measurable tumor site according to RECIST v1.1; irradiated lesions count only if progression is shown
- Adequate blood, liver, and kidney function
- Use contraception consistent with local regulations during the study
- Able to provide signed informed consent
You will not qualify if you...
- Any clinically significant heart disease
- Unresolved side effects from previous anticancer treatments
- Known untreated, active, or uncontrolled brain metastases
- Previous severe immune-related toxicity (Grade 3 or 4) leading to stopping treatment within 6 months before starting MDX2004
- Chronic use of systemic steroids over 10 mg/day prednisone equivalent or immunosuppressive therapy within 6 months before starting MDX2004
- Known HIV infection, active hepatitis B or C, or ongoing infections needing intravenous treatment
- Prior solid organ or blood stem cell transplant
- Need for supplemental oxygen for daily activities
- Considered unsuitable for participation by the investigator for any reason including medical or clinical conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 locations
1
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
2
Calvary Mater Newcastle
Waratah, New South Wales, Australia, 2298
Actively Recruiting
3
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Actively Recruiting
4
Rambam Health Care Campus
Haifa, Israel, 3109601
Actively Recruiting
5
Hadassah University Hospital-Ein Kerem
Jerusalem, Israel, 9574409
Actively Recruiting
6
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel, 6423906
Actively Recruiting
Research Team
M
ModeX Therapeutics, An OPKO Health Company
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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