Trial Identifiers
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Scientific Title
A Phase 1/1b First-in-human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of SAR439459 Administered Intravenously as Monotherapy and in Combination With Cemiplimab in Adult Patients With Advanced Solid Tumors
Commercial Sponsor
Sanofi Aventis
Summary
This is a dose escalation and expansion trial, which will involve escalation monotherapy (SAR439459 administered intravenously every 2 weeks in a 14-day cycle) and escalation combination (SAR439459 + cemiplimab combination administered intravenously every 2 weeks in a 14-day cycle or every 3 weeks in a 21-day cycle), followed by expansion monotherapy (every three weeks in a 21-day cycle, as per the recommended dose) and expansion combination. Only the expansion phases will be randomised.