Testing MDX2001 for advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety, tolerability, and anti-tumor activity of MDX2001 in patients with advanced solid tumors, including biliary tract, breast, cervical, colon, and endometrial cancers. It consists of a Phase 1a dose escalation to determine the recommended Phase 2 dose, followed by a Phase 1b and Phase 2a expansion focusing on a single indication. The study aims to assess the drug's efficacy and further characterize its pharmacokinetics and immunogenicity.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sarah Cannon Research Institute
  Denver, Colorado, United States Recruiting
• Sylvester Comprehensive Cancer Center - University of Miami Health System
  Miami, Florida, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Sarah Cannon Research Institute
  Nashville, Tennessee, United States Recruiting
• MD Anderson Cancer Center
  Houston, Texas, United States Recruiting
• NEXT Oncology
  San Antonio, Texas, United States Recruiting

Study contacts

• Study coordinator: Email recommended
• Email: info@modextx.com
• Phone: (857) 233-9936

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.