Debbie Robbrecht, Jean-Jacques Grob, Oliver Bechter, Matteo Simonelli, Bernard Doger, Ivan Borbath, Marcus O Butler, Tina Cheng, Patricia Martin Romano, Elvire Pons-Tostivint, Massimo Di Nicola, Giuseppe Curigliano, Min-Hee Ryu, Alejo Rodriguez-Vida, Dirk Schadendorf, Elena Garralda, Giovanni Abbadessa, Brigitte Demers, Amele Amrate, Hong Wang, Joon Sang Lee, Robert Pomponio, Rui Wang
SAR439459, a 'second-generation' human anti-transforming growth factor-beta (TGFβ) monoclonal antibody, inhibits all TGFβ isoforms and improves the antitumor activity of anti-programmed cell death protein-1 therapeutics. This study reports the pharmacodynamics (PD) and biomarker results from phase I/Ib first-in-human study of SAR439459 ± cemiplimab in patients with advanced solid tumors (NCT03192345). In dose-escalation phase (Part 1), SAR439459 was administered intravenously at increasing doses either every 2 weeks (Q2W) or every 3 weeks (Q3W) with cemiplimab IV at 3 mg/kg Q2W or 350 mg Q3W, respectively, in patients with advanced solid tumors...
February 2024: Clinical and Translational Science