NCT07110584 Dose Escalation and Dose Expansion Study of MDX2004 in Participants With Advanced Tumors
| NCT ID | NCT07110584 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | ModeX Therapeutics, An OPKO Health Company |
| Condition | Advanced Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 235 participants |
| Start Date | 2025-10-01 |
| Primary Completion | 2031-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 235 participants in total. It began in 2025-10-01 with a primary completion date of 2031-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2004 in patients with advanced tumors.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07110584 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07110584 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07110584 currently recruiting?
Yes, NCT07110584 is actively recruiting participants. Contact the research team at info@modextx.com for enrollment information.
Where is the NCT07110584 trial being conducted?
This trial is being conducted at Liverpool, Australia, Waratah, Australia, Woolloongabba, Australia, Haifa, Israel and 2 additional locations.
Who is sponsoring the NCT07110584 clinical trial?
NCT07110584 is sponsored by ModeX Therapeutics, An OPKO Health Company. The trial plans to enroll 235 participants.