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A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Sponsor: Hoffmann-La Roche
Summary
This open-label, exploratory study is designed to evaluate the safety and efficacy of targeted therapies or immunotherapy as single agents or combinations, in participants with metastatic colorectal cancer (mCRC) whose tumors are biomarker positive as per treatment arm-specific definition. Eligible participants with mCRC will be enrolled into specific treatment arms based on their biomarker assay results.
Official title: A Phase I/Ib Global, Multicenter, Open-label Umbrella Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
542
Start Date
2021-10-22
Completion Date
2030-08-31
Last Updated
2026-03-31
Healthy Volunteers
No
Conditions
Interventions
Inavolisib
Inavolisib will be administered orally as per schedule specified in the respective arms.
Bevacizumab
Bevacizumab IV will be administered as per schedule specified in the respective arm.
Cetuximab
Cetuximab IV will be administered as per schedule specified in the respective arm.
Atezolizumab
Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.
Tiragolumab
Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.
SY-5609
SY-5609 will be administered by mouth as per schedule specified in the respective arm.
Divarasib
Divarasib will be administered orally as per schedule specified in the respective arms.
FOLFOX
FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.
FOLFIRI
FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.
FoundationOne®Liquid CDx
FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.
Locations (74)
UAB Comprehensive Cancer Center
Birmingham, Alabama, United States
Mayo Clinic Arizona
Phoenix, Arizona, United States
City of Hope Comprehensive Cancer Center
Duarte, California, United States
cCare
Encinitas, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
UCLA
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Stanford Cancer Center
Stanford, California, United States
University of Colorado Cancer Center
Aurora, Colorado, United States
Yale Cancer Center
New Haven, Connecticut, United States
Eastern Ct Hema/Onco Assoc
Norwich, Connecticut, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Mary Bird Perkins Cancer Ctr
Baton Rouge, Louisiana, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Karmanos Cancer Institute
Detroit, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
New York Cancer & Blood Specialists - New Hyde Park
New Hyde Park, New York, United States
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
New York, New York, United States
New York Cancer & Blood Specialists
Port Jefferson Station, New York, United States
New York Cancer & Blood Specialists - Bronx
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Hematology Oncology Salem
Salem, Oregon, United States
UPMC - Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
Sarah Cannon Research Institute / Tennessee Oncology
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Lumi Research
Kingwood, Texas, United States
Swedish Cancer Inst.
Seattle, Washington, United States
Medical Oncology Associates
Spokane, Washington, United States
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
McGill University Health Center
Montreal, Quebec, Canada
Rigshospitalet, Onkologisk Klinik
København Ø, Denmark
Charité Universitätsmedizin Berlin
Berlin, Germany
Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
Bochum, Germany
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
Dresden, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Asklepios Klinik Altona
Hamburg, Germany
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
Heilbronn, Germany
Klinikum der Universität München, Campus Großhadern
München, Germany
Universitätsklinikum Ulm
Ulm, Germany
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, Italy
Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
Milan, Lombardy, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Veneto, Italy
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
Krakow, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, Poland
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
Warsaw, Poland
National Cancer Center
Goyang-si, South Korea
Chonnam National University Hwasun Hospital
Jeollanam-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda, Madrid, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
Madrid, Spain
START Madrid. Centro Integral Oncologico Clara Campal
Madrid, Spain
Hospital Clínico Universitario de Valencia
Valencia, Spain
National Cheng Kung University Hospital
Tainan, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
National Taiwan University Hospital
Zhongzheng Dist., Taiwan
Addenbrookes Hospital
Cambridge, United Kingdom
Velindre Cancer Centre
Cardiff, United Kingdom
Royal Free Hospital
London, United Kingdom
Royal Marsden Hospital;Dept of Med-Onc
London, United Kingdom
Sarah Cannon Research Institute
London, United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
The Christie NHS Foundation Trust
Manchester, United Kingdom
Royal Marsden Hospital
Sutton, United Kingdom