CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 155 enrolled / 155 target
Drug / intervention
PF-06801591drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04181788
NCT04181788Phase 1CompletedMonitor (2.0/mo)Completion was 51mo ago
CompareCT.gov

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

Pfizer·interventional·Posted Nov 29, 2019·Updated Jun 15, 2026

In Brief

A Phase 1 clinical trial evaluating PF-06801591 for Advanced Malignancies and Non-small-cell Lung Cancer. Completed, enrolled 155 participants across 49 sites in 6 countries.

Signals

Enrolling slower than its timeline implies

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAdvanced Malignancies, Non-small-cell Lung Cancer
CountriesChina, Japan, Russia, South Korea, Taiwan, Ukraine
Collaborators--

Timeline

Phase 1CompletedFinished
2020202120222023202420252026
First PostedNov 29, 2019
Enrollment StartMar 18, 2020
Primary CompletionMar 3, 2022
Study CompletionMay 13, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.6 years ago

Arms & Interventions

Arm A1 (Phase 1b)experimental

Drug: PF-06801591
Arm B1 (Phase 1b)experimental

Drug: PF-06801591
Arm A2 (Phase 2)experimental

Drug: PF-06801591
Arm B2 (Phase 2)experimental

Drug: PF-06801591

Interventions

PF-06801591drug

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