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Dose Escalation and Dose Expansion Study of MDX2001 in Patients With Advanced Solid Tumors

Eligible age

18+ yrs

Accepts

All genders

Locations

5 states

Healthy volunteers

No

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About this study

This study is designed to characterize the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors.

Sponsor: ModeX Therapeutics, An OPKO Health Company

You may qualify if…

  • Patients must be ≥ 18 years of age
  • Histologically or cytologically confirmed diagnosis of metastatic solid tumors
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • All patients should have at least 1 measurable disease per RECIST v1.1. An irradiated lesion can be considered measurable only if progression has been demonstrated on the irradiated lesion.
  • All contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Adequate hematologic, hepatic and renal function
  • Capable of giving signed informed consent

You may not qualify if…

  • Any clinically significant cardiac disease
  • Unresolved toxicities from previous anticancer therapy
  • Prior solid organ or hematologic transplant
  • Known untreated, active, or uncontrolled brain metastases
  • Known positivity with human immunodeficiency virus (HIV), known active hepatitis B or C, or uncontrolled chronic or ongoing infectiion requiring intravenous treatment.
  • Receipt of a live-virus vaccination within 28 days of planned treatment start
  • Patient not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions.
  • Participation in a concurrent clinical study in the treatment period.

Where it's recruiting

Colorado

Denver

Florida

Miami

Tennessee

Nashville

Texas

Houston · San Antonio

Source: ClinicalTrials.gov · NCT06239194 · last updated 2026-05-06

Dose Escalation and Dose Expansion Study of MDX2001 in Patients With A · TrialPath