NCT04181788

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

A Phase 1b/2 Open-Label Study to Evaluate Pharmacokinetics, Safety, Efficacy, and Pharmacodynamics of PF-06801591 (PD-1 Inhibitor) in Participants With Advanced Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Advanced Malignancies
• Non-small-cell Lung Cancer

Interventions

Type	Name	Description
DRUG	PF-06801591	A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.

Timeline

• Start date: 2020-03-18
• Primary completion: 2022-03-03
• Completion: 2026-06-09
• First posted: 2019-11-29
• Last updated: 2026-03-18
• Results posted: 2023-05-08

Locations

48 sites across 6 countries: China, Japan, Russia, South Korea, Taiwan, Ukraine

Regulatory

• FDA-regulated drug study