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NCT06239194 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study of Breast Cancer and Head and Neck Cancer, sponsored by ModeX Therapeutics, An OPKO Health Company.

Recruiting
Registry status
Phase 1
Development phase
115
Enrollment target
6
Study locations

NCT06239194: Recruiting Phase 1 study of Breast Cancer and Head and Neck Cancer, sponsored by ModeX Therapeutics, An OPKO Health Company.

NCT06239194 is a Phase 1 study of Breast Cancer and Head and Neck Cancer that is actively recruiting participants, run by ModeX Therapeutics, An OPKO Health Company. The registered enrollment target is 115 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06239194, a Phase 1 study of Breast Cancer and Head and Neck Cancer, is actively recruiting participants, sponsored by ModeX Therapeutics, An OPKO Health Company.

RECRUITING
Registry status
Phase 1
Development phase
115 participants
Enrollment target
6
Study locations

Study Summary

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

Primary Outcome

Incidence and severity of AEs and serious AEs (SAEs) graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0 including changes in clinical laboratory parameters

Interventions

  • DRUG MDX2001

Study Locations (6)

Texas

  • MD Anderson Cancer Center - Houston
  • NEXT Oncology - San Antonio

Colorado

  • Sarah Cannon Research Institute - Denver

Florida

  • Sylvester Comprehensive Cancer Center - University of Miami Health System - Miami

Massachusetts

  • Massachusetts General Hospital - Boston

Tennessee

  • Sarah Cannon Research Institute - Nashville

Trial Details

FieldValue
Enrollment Target 115 participants
Start Date 2024-06-12
Est. Completion 2029-02
Phase Phase 1

What NCT06239194 shows while recruiting

NCT06239194 is an interventional study that assigns participants to a tested intervention. The registered 115 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (96% lower).

The record links to 10 conditions, with Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which MDX2001 is the first listed.

NCT06239194 lists 6 locations in 5 states (Texas, Colorado, Florida).

Frequently Asked Questions

What is clinical trial NCT06239194 about?

NCT06239194 is a clinical study titled "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.

What is the current status of trial NCT06239194?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 115 participants. The study started on 2024-06-12. Estimated completion is 2029-02.

What conditions does trial NCT06239194 study?

This clinical trial studies the following conditions: Breast Cancer, Head and Neck Cancer, Endometrial Cancer, Gastric Cancer, Cervical Cancer.

What interventions are being tested in trial NCT06239194?

The interventions under investigation include: MDX2001 (DRUG).

Who is sponsoring clinical trial NCT06239194?

This trial is sponsored by ModeX Therapeutics, An OPKO Health Company, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06239194 being conducted?

This trial has 6 study locations across Colorado, Florida, Massachusetts, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06239194's enrollment target sits among peer trials

115 523rd of 1224 higher than 697 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06239194, the US trial registry maintained by the National Library of Medicine. NCT06239194 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.