A Study of GDC-0919 and Atezolizumab Combination Treatment in Participants With Locally Advanced or Metastatic Solid Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

July 28, 2015

Primary Completion Date

October 2, 2019

Study Completion Date

October 2, 2019

Conditions
Solid Tumor
Interventions
DRUG

Atezolizumab

Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle with the exception of biopsy cohort A, where atezolizumab administration will start on Cycle 2 Day 1.

DRUG

GDC-0919

Participants will receive GDC-0919 by mouth (PO) twice daily (BID), specifically every 12 hours. During the dose-escalation stage, the first cohort will receive GDC-0919 at a starting dose of 50 mg PO BID. Dosing will commence on Day -1 for Cycle 1 and follow subsequent 21-day (Days 1 to 21) dosing cycles. The dose will be modified based upon evaluation of DLTs, with single dose escalations not to exceed 2.5-fold of the previous dose. The proposed dosages for evaluation are 50, 100, 200, 400, 600, and 1000 mg PO BID. During the expansion stage, selected solid tumor types will be treated at the MTD or MAD as determined during the dose-escalation stage.

Trial Locations (18)

6351

Samsung Medical Center, Seoul

10065

Memorial Sloan Kettering Cancer Center, New York

13015

Hopital Nord AP-HM, Marseille

21231

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

28050

Hospital Universitario HM Sanchinarro-CIOCC, Madrid

33612

H. Lee Moffitt Cancer Center and Research Inst., Tampa

37203

Sarah Cannon Research Institute, Nashville

46010

Hospital Clinico Universitario de Valencia, Valencia

85258

HonorHealth Research Institute - Bisgrove, Scottsdale

90025

The Angeles Clinic and Research Institute, Santa Monica Office, Santa Monica

94805

Institut Gustave Roussy, Villejuif

80045-2517

University of Colorado, Aurora

06520

Yale Cancer Center, New Haven

02215

Beth Israel Deaconess Medical Center, Boston

Dana Farber Cancer Institute, Boston

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center - Oncology, Seoul

08035

Hospital Universitari Vall d'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY