RecruitingPhase 1Phase 2NCT06239194

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

A Phase 1/2a, Multicenter, First-in-human, Open-label Clinical Trial Evaluating MDX2001 Monotherapy in Patients With Advanced Solid Tumors


Sponsor

ModeX Therapeutics, An OPKO Health Company

Enrollment

115 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new investigational drug called MDX2001 in people with advanced solid tumors. This is a dose escalation and dose expansion trial — meaning researchers are first figuring out the right dose, then expanding to more patients. It is an early-phase trial focusing primarily on safety. **You may be eligible if...** - You are 18 or older - You have a confirmed advanced solid tumor cancer (any type that has spread) - You have at least one measurable tumor on scans - Your general health status is good (ECOG 0–1) - Your heart, liver, kidneys, and blood counts are functioning adequately **You may NOT be eligible if...** - You have significant heart disease - You have unresolved side effects from prior cancer treatment - You have had an organ or bone marrow transplant - You have untreated or uncontrolled brain metastases - You are HIV positive, or have active hepatitis B or C - You have received a live vaccine within 28 days of starting treatment - You are currently enrolled in another treatment trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDX2001

MDX2001 intravenous infusion


Locations(6)

Sarah Cannon Research Institute

Denver, Colorado, United States

Sylvester Comprehensive Cancer Center - University of Miami Health System

Miami, Florida, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

MD Anderson Cancer Center

Houston, Texas, United States

NEXT Oncology

San Antonio, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT06239194


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