RecruitingPhase 1 / Phase 2NCT06239194

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

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

Checked against the public recordLast updated May 6, 2026 · Source: ClinicalTrials.gov

StatusRecruiting
PhasePhase 1 / Phase 2
U.S. locations6
SponsorModeX Therapeutics, An OPKO Health Company
01
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
02
Explore related studies

How this study is categorized

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

03
Public criteria

Who may be able to participate

Inclusion 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 Exclusion 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.

04
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: May 6, 2026. Always confirm current availability with the study team.

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