Study on MDX2001 for Patients with Advanced Solid Tumors

Sponsor: ModeX Therapeutics, An OPKO Health Company

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06239194

Provider View

This clinical trial is testing a new drug, MDX2001, to see if it is safe and effective in treating patients with advanced solid tumors. The study will also determine the best dose for future research.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the safety and effectiveness of a new drug called MDX2001 in patients with advanced solid tumors. The study is divided into different phases to find the best dose and to see how well the drug works against tumors. Participants will be monitored for about 10 months, including screening, treatment, and follow-up periods.

Description

This study is divided into several phases:

  • Phase 1a: The focus is on finding a safe dose of MDX2001 for patients with advanced solid tumors.
  • Phase 1b: The study will expand to more patients to further test the drug's safety and start evaluating its effectiveness against tumors.
  • Phase 2a: The study will continue to assess how well MDX2001 works in treating specific types of advanced solid tumors.

Primary Goals:

  • To ensure MDX2001 is safe and well-tolerated by patients.
  • To find the best dose for future studies.
  • To evaluate the drug's effectiveness in shrinking tumors.

Secondary Goals:

  • To gather more information on how MDX2001 affects tumors.
  • To study how the body processes the drug.
  • To understand how the drug interacts with the immune system.
  • To explore the relationship between tumor characteristics and treatment benefits.

Participants will be involved in the study for about 10 months, which includes screening, treatment, and follow-up.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Have a confirmed diagnosis of advanced solid tumors.
  • Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
  • Have at least one measurable tumor that can be tracked using standard criteria.
  • Use contraception as required by local regulations.
  • Have adequate blood, liver, and kidney function.
  • Be able to provide informed consent.

Exclusion Criteria

  • Have significant heart disease.
  • Have unresolved side effects from previous cancer treatments.
  • Have had a solid organ or blood cell transplant.
  • Have untreated or uncontrolled brain cancer.
  • Test positive for HIV, active hepatitis B or C, or have uncontrolled infections.
  • Have received a live vaccine within 28 days before starting the study.
  • Be deemed unsuitable for the study by the investigator for any reason.
  • Be participating in another clinical study during the treatment period.
  • Have an allergy to MDX2001 or its ingredients.

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