Phase I/Ib Study of NIS793 in Combination With PDR001 in Patients With Advanced Malignancies.

Summary

To characterize the safety and tolerability of NIS793 as single agent and in combination with PDR001 and to identify recommended doses for future studies.

Timeline

Start

2017-04-25

Primary completion

2021-06-18

Completion

2021-06-18

Publications

• Bauer TM, Santoro A, Lin CC, Garrido-Laguna I, Joerger M, Greil R, Spreafico A, Yau T, Goebeler ME, Hutter-Kronke ML, Perotti A, Juif PE, Lu D, Barys L, Cremasco V, Pelletier M, Evans H, Fabre C, Doi T. Phase I/Ib, open-label, multicenter, dose-escalation study of the anti-TGF-beta monoclonal antibody, NIS793, in combination with spartalizumab in adult patients with advanced tumors. J Immunother Cancer. 2023 Nov 29;11(11):e007353. doi: 10.1136/jitc-2023-007353.
• Dodagatta-Marri E, Meyer DS, Reeves MQ, Paniagua R, To MD, Binnewies M, Broz ML, Mori H, Wu D, Adoumie M, Del Rosario R, Li O, Buchmann T, Liang B, Malato J, Arce Vargus F, Sheppard D, Hann BC, Mirza A, Quezada SA, Rosenblum MD, Krummel MF, Balmain A, Akhurst RJ. alpha-PD-1 therapy elevates Treg/Th balance and increases tumor cell pSmad3 that are both targeted by alpha-TGFbeta antibody to promote durable rejection and immunity in squamous cell carcinomas. J Immunother Cancer. 2019 Mar 4;7(1):62. doi: 10.1186/s40425-018-0493-9.

Drugs

Indications