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

Inclusion criteria: * At least 18 years of age * Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase). * Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases). * Minimum 3 lesions enrollment. * Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement). * A lesion amenable for additional tumor biopsy. * Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. * Life expectancy more than 3 months. * Willingness to provide mandatory tumor biopsy. * Male and female patients who agree to use effective contraceptive methods. * Signed informed consent. 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.