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

Summary

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

Interventions

• MDX2001 · DRUG

  MDX2001 intravenous infusion

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (6)

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