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. Anirradiated lesion can be considered measurable only if progression has beendemonstrated on the irradiated lesion.

• All contraceptive use by men and women should be consistent with local regulationsregarding 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 Bor C, or uncontrolled chronic or ongoing infectious 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 theInvestigator, including medical or clinical conditions.

• Participation in a concurrent clinical study in the treatment period.

• Known hypersensitivity to MDX2001 or any of its ingredients

The above information is not intended to contain all considerations relevant to the potential participation in a clinical trial.