At a glance

ClinicalIndex Comparison Record

Phase 1Completed· 661 enrolled

Drug / intervention

Atezolizumabdrug

Likely dose

Atezolizumab 20 mg/kgfrom 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/NCT01375842

NCT01375842Phase 1Completed

Compare CT.gov

A Phase I, Open-Label, Dose-Escalation Study of the Safety and Pharmacokinetics of Atezolizumab (MPDL3280A) Administered Intravenously as a Single Agent to Patients With Locally Advanced or Metastatic Solid Tumors or Hematologic Malignancies

Genentech, Inc.·interventional·Posted Jun 17, 2011·Updated Dec 11, 2018

In Brief

A Phase 1 clinical trial evaluating Atezolizumab for Tumors and Hematologic Malignancies. Completed, enrolled 661 participants across 21 sites in 4 countries.

Detailed Summary

This Phase I, multicenter, first-in-human, open-label, dose-escalation study will evaluate the safety, tolerability, and pharmacokinetics of atezolizumab (MPDL3280A) administered as single agent to participants with locally advanced or metastatic solid malignancies or hematologic malignancies. The study will be conducted in two cohorts: Dose-escalation cohort and Expansion cohort.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsTumors, Hematologic Malignancies

CountriesFrance, Spain, United Kingdom, United States

Collaborators--

Timeline

Phase 1CompletedFinished

201220132014201520162017201820192020202120222023202420252026

First PostedJun 2011

Enrollment StartJun 2011

Primary CompletionSep 2018

TodayJul 2026

First PostedJun 17, 2011

Enrollment StartJun 21, 2011

Primary CompletionSep 30, 2018

TodayJul 2, 2026

Enrollment to primary: 7.3 yearsPosted 15.0 years ago

Interventions

Atezolizumabdrug

Atezolizumab will be administered as IV infusion at eight dose levels (0.01, 0.03, 0.1, 0.3, 1, 3, 10, 20 mg/kg) in dose escalation cohort and at a dose which result in total drug exposure \</= exposures achieved at the MTD or MAD, will be selected for expansion cohort.