A Study of Atezolizumab (an Engineered Anti-Programmed Death-Ligand 1 [PDL1] Antibody) to Evaluate Safety, Tolerability and Pharmacokinetics in Participants With Locally Advanced or Metastatic Solid Tumors

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Genentech, Inc.
Study ID
NCT01375842
Phase
PHASE1
Status
Completed

Conditions

  • Hematologic Malignancies
  • Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    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.

Study Details

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.

Key Dates

Start date
Jun 21, 2011
Status verified
Dec 2018
Primary completion
Sep 30, 2018
Completion
Sep 30, 2018

Study Design

Enrollment
661 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Escalation Cohort: Atezolizumab 0.01 mg/kg
    Participants will receive intravenous (IV) infusion of atezolizumab 0.01 milligrams per kilogram (mg/kg) every 3 weeks (q3w) until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 0.03 mg/kg
    Participants will receive IV infusion of atezolizumab 0.03 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 0.1 mg/kg
    Participants will receive IV infusion of atezolizumab 0.1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 0.3 mg/kg
    Participants will receive IV infusion of atezolizumab 0.3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 1 mg/kg
    Participants will receive IV infusion of atezolizumab 1 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 3 mg/kg
    Participants will receive IV infusion of atezolizumab 3 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 10 mg/kg
    Participants will receive IV infusion of atezolizumab 10 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Dose Escalation Cohort: Atezolizumab 20 mg/kg
    Participants will receive IV infusion of atezolizumab 20 mg/kg q3w until DLT is reached or up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first.
  • Experimental: Expansion Cohort (Atezolizumab)
    Participants will receive IV infusion of atezolizumab q3w up to end of study or treatment discontinuation or death or until initiation of another anti cancer therapy, whichever occurs first. The dose which result in total drug exposure less than or equal to (\</=) exposures achieved at the MTD or maximum administered dose (MAD), will be selected for expansion cohort.

Primary Outcome Measure

Number of Participants With Dose Limiting Toxicities (DLTs) [ Time Frame: Day 1 up to Day 21 ]

Locations (16)

FacilityCityStateZIPSite coordinators
HonorHealth Research Institute - Pima CenterScottsdaleArizona85258-
The Angeles ClinicLos AngelesCalifornia90025-
Stanford Univ Medical Center; Dept Central PharmacyStanfordCalifornia94305-
Yale Cancer CenterNew HavenConnecticut06520-
Moffitt Cancer CenterTampaFlorida33647-
Uni of ChicagoChicagoIllinois60637-
Johns Hopkins Univ Med CenterBaltimoreMaryland21231-
Beth Israel Deaconess Med CtrBostonMassachusetts02215-
Dana Farber Can InsBostonMassachusetts02215-
Massachusetts General Hospital.BostonMassachusetts02114-
Comprehensive Cancer Centers of Nevada - Eastern AvenueLas VegasNevada89169-
New York Oncology Hematology, P.C.AlbanyNew York12206-
Carolina BioOncology Institute; Can Therapy & Res CtrHuntersvilleNorth Carolina28078-
Sarah Cannon Research Inst.NashvilleTennessee37203-
VanderbiltNashvilleTennessee37232-
Virginia Oncology AssociatesNorfolkVirginia23502-

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By research site
HonorHealth Research Institute - Pima Center· Scottsdale, AZThe Angeles Clinic· Los Angeles, CAStanford Univ Medical Center; Dept Central Pharmacy· Stanford, CAYale Cancer Center· New Haven, CTMoffitt Cancer Center· Tampa, FLUni of Chicago· Chicago, IL

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