RecruitingPhase 1NCT04929223

A Study Evaluating the Safety and Efficacy of Targeted Therapies in Subpopulations of Patients With Metastatic Colorectal Cancer (INTRINSIC)

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)

Sponsor

Hoffmann-La Roche

Enrollment

542 participants

Start Date

Oct 22, 2021

Study Type

INTERVENTIONAL

Conditions

Metastatic Colorectal Cancer

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests several targeted drug therapies in patients with advanced colorectal cancer (cancer of the large intestine that has spread), where each treatment is matched to a specific genetic change in the tumor. **You may be eligible if...** - You have been diagnosed with metastatic colorectal cancer (cancer that has spread beyond the colon or rectum) - You are 18 or older - Your tumor has been tested and found to have a specific genetic mutation or biomarker that matches one of the study's treatment groups - You have had prior treatment for your colorectal cancer **You may NOT be eligible if...** - Your tumor does not have one of the specific genetic changes being studied - You have not had prior treatment for colorectal cancer - You are pregnant or breastfeeding - You have certain other serious health conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInavolisib

Inavolisib will be administered orally as per schedule specified in the respective arms.

DRUGBevacizumab

Bevacizumab IV will be administered as per schedule specified in the respective arm.

DRUGCetuximab

Cetuximab IV will be administered as per schedule specified in the respective arm.

DRUGAtezolizumab

Atezolizumab IV infusion will be administered as per schedule specified in the respective arm.

DRUGTiragolumab

Tiragolumab IV infusion will be administered as per schedule specified in the respective arm.

DRUGSY-5609

SY-5609 will be administered by mouth as per schedule specified in the respective arm.

DRUGDivarasib

Divarasib will be administered orally as per schedule specified in the respective arms.

DRUGFOLFOX

FOLFOX (5-fluorouracil, leucovorin, oxaliplatin) IV will be administered as per schedule specified in the respective arm.

DRUGFOLFIRI

FOLFIRI (leucovorin, 5-fluorouracil, irinotecan) IV will be administered as per schedule specified in the respective arm.

DIAGNOSTIC_TESTFoundationOne®Liquid CDx

FoundationOne®Liquid CDx is used to identify presence of genomic alterations for participant cohort assignment.

Locations(76)

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

Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

Meldola, Emilia-Romagna, 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

Uniwersyteckie Centrum Kliniczne, O?rodek Bada? Klinicznych Wczesnych Faz

Gdansk, Poland

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

View Full Details on ClinicalTrials.gov

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NCT04929223

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