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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

Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 24 Feb 2025

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At a glance

  • Drugs Sasanlimab (Primary)
  • Indications Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Pfizer

Most Recent Events

  • 18 Feb 2025 Phase changed from I/II to II.
  • 18 Feb 2025 Planned End Date changed from 17 Jan 2025 to 30 Apr 2025.
  • 15 Mar 2022 Planned primary completion date changed from 1 Mar 2023 to 11 May 2022.

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