Sasanlimab (PF-06801591, PD-1 Inhibitor) in Participants With Advanced Malignancies

Summary

This is a Phase 1b/2 protocol to evaluate pharmacokinetics, safety, efficacy, and pharmacodynamics of PF-06801591, a programmed death-1(PD-1) antagonist monoclonal antibody (mAb) in participants with advanced malignancies. This study consists of 2 parts: Phase 1b part (dose escalation and dose expansion) in patients with advanced malignancies in Asia and a global Phase 2 part in non small cell lung cancer (NSCLC) patients.

Timeline

Start

2020-03-18

Primary completion

2022-03-03

Completion

2026-05-13

Publications

• Penkov K, Bondarenko I, Saenko DV, Kulyaba Y, Guo J, Gong Y, Yamamoto N, Hotko YS, Boyko V, Fadeeva NV, Ursol GM, Ahn HK, Kislov NV, Shen CI, Davis C, Kowalski K, Michelon E, Pavlov D, Hirohashi T, Cho BC. Pharmacokinetics, safety, and efficacy of an alternative dosing regimen of sasanlimab in participants with advanced NSCLC and other malignancies. Ther Adv Med Oncol. 2024 Sep 11;16:17588359241274592. doi: 10.1177/17588359241274592. eCollection 2024.

Drugs

Indications