Safety and Pharmacokinetics (PK) of Escalating Doses of Tiragolumab as a Single Agent and in Combination With Atezolizumab and/or Other Anti-Cancer Therapies in Locally Advanced or Metastatic Tumors

PHASE1CompletedINTERVENTIONAL
Enrollment

518

Participants

Timeline

Start Date

May 23, 2016

Primary Completion Date

November 13, 2024

Study Completion Date

November 13, 2024

Conditions
Advanced/Metastatic Tumors
Interventions
DRUG

Atezolizumab

Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle.

DRUG

Tiragolumab

Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and/or other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and/or other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit.

DRUG

Carboplatin

Carboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion.

DRUG

Cisplatin

Cisplatin 75 milligram per square meter (mg/m\^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.

DRUG

Pemetrexed

Pemetrexed 500 mg/m\^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab.

DRUG

Paclitaxel

Paclitaxel 200 mg/m\^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab.

DRUG

Etoposide

Etoposide 100 mg/m\^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab.

DRUG

Capecitabine

Capecitabine 1250 mg/m\^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.

DRUG

Bevacizumab

Bevacizumab 15 mg/kg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.

DRUG

Pembrolizumab

Pembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab.

Trial Locations (28)

2010

Kinghorn Cancer Centre; St Vincents Hospital, Darlinghurst

3051

Peter MacCallum Cancer Center, North Melbourne

10065

Memorial Sloan-Kettering Cancer Center, New York

21287

Johns Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

28050

Hospital Universitario HM Sanchinarro-CIOCC; Oncología Médica, Madrid

31008

Clinica Universitaria de Navarra; Servicio de oncología, Pamplona

31059

Institut Claudius Regaud; Departement Oncologie Medicale, Toulouse

33000

Institut Bergonie CLCC Bordeaux, Bordeaux

37203

Tennessee Oncology - Nashville, Nashville

46010

Hospital Clinico Universitario de Valencia, Valencia

48202

Henry Ford Hospital, Detroit

69008

Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes, Lyon

75005

Institut Curie, Paris

85258

Honor Health Research Institute, Scottsdale

90404

University of California Los Angeles, Santa Monica

94805

Institut Gustave Roussy, Villejuif

06520

Yale Cancer Center, New Haven

02215

Dana Farber Cancer Institute, Boston

M4X 1K9

Princess Margaret Hospital, Toronto

104-0045

National Cancer Center Hospital, Tokyo

135-8550

The Cancer Institute Hospital of Japanese Foundation For Cancer Research, Tokyo

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08908

ICO L'Hospitalet; Servicio de oncologia medica, L'Hospitalet de Llobregat

08740

Hospital Univ Vall d'Hebron; Servicio de Oncologia, Sant Andreu de la Barca

08003

Hospital del Mar, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Genentech, Inc.

INDUSTRY