Actively Recruiting

Phase 1
Phase 2
Age: 18Years +
All Genders
NCT06239194

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

Led by ModeX Therapeutics, An OPKO Health Company · Updated on 2026-05-06

285

Participants Needed

6

Research Sites

242 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 MDX2001 in patients with advanced solid tumors.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must be 18 years of age or older
  • Confirmed diagnosis of metastatic solid tumors by tissue analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • At least one measurable tumor lesion per RECIST v1.1 criteria
  • Use of contraception according to local clinical study regulations for men and women
  • Adequate blood, liver, and kidney function
  • Able to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Clinically significant heart disease
  • Unresolved side effects from previous cancer treatments
  • Previous solid organ or blood transplant
  • Untreated, active, or uncontrolled brain metastases
  • Known HIV infection, active hepatitis B or C, or uncontrolled infections requiring IV treatment
  • Receipt of live-virus vaccination within 28 days before treatment start
  • Deemed unsuitable for participation by the investigator due to medical or clinical reasons
  • Participation in another clinical study during the treatment period
  • Known allergy to MDX2001 or its ingredients
  • Use of supplemental oxygen for daily activities

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Sarah Cannon Research Institute

Denver, Colorado, United States, 80218

Actively Recruiting

2

Sylvester Comprehensive Cancer Center - University of Miami Health System

Miami, Florida, United States, 33136

Actively Recruiting

3

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

4

Sarah Cannon Research Institute

Nashville, Tennessee, United States, 37203

Actively Recruiting

5

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

6

NEXT Oncology

San Antonio, Texas, United States, 78229

Actively Recruiting

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Research Team

E

Email recommended

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SEQUENTIAL

Primary Purpose

TREATMENT

Number of Arms

4

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