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

NCT04181788 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 155

Last updated 2026-04-27

Study results available
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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

DRUG

PF-06801591

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-18
Primary Completion
2022-03-03
Completion
2026-06-09
FDA Drug
Yes

Countries

  • China
  • Japan
  • Russia
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04181788 on ClinicalTrials.gov