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

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.