A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors

Exclusion Criteria

• •Eastern Cooperative Oncology Group (ECOG) performance score \>1.
• •Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study.
• •Any prior organ transplantation.
• •History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment.
• •History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
• •Prior splenectomy.
• •New and progressive brain lesions.
• •Poor bone marrow reserve resulting in low blood cell count.
• •Poor liver and kidney functions, abnormal coagulation tests.
• •Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
• •Maintenance therapy with prednisolone \>7.5 mg/day orally or equivalent during the study.
• •Non-resolution of any prior treatment related toxicity to Grade \<2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies.
• •Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment.
• •Central nervous system lymphoma.
• •Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma.
• •Autologous HSCT less than 90 days prior to initiation of study intervention.
• •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.