RecruitingPhase 1Phase 2NCT07110584

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

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

Sponsor

ModeX Therapeutics, An OPKO Health Company

Enrollment

235 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

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.

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.