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

Study summary

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

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedMDX2001

The study team can explain what participation involves.

Who it may be forNon-small cell lung cancer (NSCLC) · Mesothelioma

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 15, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Recruiting

The study is currently accepting participants.

What kind of study?Phase 1 / Phase 2

Interventional

Where is it offered?6 U.S. locations

Locations may change over time.

Who runs it?ModeX Therapeutics, An OPKO Health Company

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1 / Phase 2
Sponsor: ModeX Therapeutics, An OPKO Health Company
Interventions being studied: Drug: MDX2001

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Cancer type

Non-small cell lung cancer (NSCLC)→Mesothelioma→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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

Reasons someone may not be able to joinExclusion criteria

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.
Known hypersensitivity to MDX2001 or any of its ingredients
Supplemental oxygen use for activities of daily living The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

Sarah Cannon Research InstituteDenver, Colorado
Sylvester Comprehensive Cancer Center - University of Miami Health SystemMiami, Florida
Massachusetts General HospitalBoston, Massachusetts
Sarah Cannon Research InstituteNashville, Tennessee
MD Anderson Cancer CenterHouston, Texas
NEXT OncologySan Antonio, Texas

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 15, 2026. Always confirm current availability with the study team.

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