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)

Status: Recruiting
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Signed cohort-specific Informed Consent Form

• Age \>= 18 years at time of signing Informed Consent Form

• Biomarker eligibility as determined by:

‣ A validated test approved by local health authorities for detection of the specified biomarkers/mutations.

⁃ A validated test performed at a College of American Pathologists/clinical laboratory improvement amendments (CAP/CLIA) -certified or equivalently accredited diagnostic laboratory using a validated test for detection of the specified biomarkers.

⁃ Prior test results completed before signing cohort-specific Informed Consent Form or local test results generated prior to or during screening, and availability of a full report of the testing results OR

⁃ Blood-based FoundationOne Liquid CDx biomarker eligibility test result generated prior to or during screening or, in case of re-enrollment after treatment discontinuation, prior to starting a new anti-cancer therapy.

• Eastern Cooperative Oncology Group (ECOG) Performance Status of \<= 1

• Life expectancy \>= 3 months, as determined by the investigator

• Histologically confirmed adenocarcinoma originating from the colon or rectum

• Metastatic disease

• Prior therapies for metastatic disease

• Ability to comply with the study protocol, in the investigators judgment

• Measurable disease (at least one target lesion) according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)

• Baseline tumor tissue samples will be collected from all participants for exploratory biomarker research

• Adequate hematologic and organ function within 14 days prior to initiation of study treatment

• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures

• For men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm

Locations
United States
Alabama
UAB Comprehensive Cancer Center
WITHDRAWN
Birmingham
Arizona
Mayo Clinic Arizona
COMPLETED
Phoenix
California
City of Hope Comprehensive Cancer Center
ACTIVE_NOT_RECRUITING
Duarte
cCare
WITHDRAWN
Encinitas
Cedars-Sinai Medical Center
ACTIVE_NOT_RECRUITING
Los Angeles
UCLA
RECRUITING
Los Angeles
USC Norris Cancer Center
RECRUITING
Los Angeles
Hoag Memorial Hospital Presbyterian
WITHDRAWN
Newport Beach
Stanford Cancer Center
COMPLETED
Stanford
Colorado
University of Colorado Cancer Center
ACTIVE_NOT_RECRUITING
Aurora
Connecticut
Yale Cancer Center
RECRUITING
New Haven
Eastern Ct Hema/Onco Assoc
RECRUITING
Norwich
Florida
Mayo Clinic in Florida
ACTIVE_NOT_RECRUITING
Jacksonville
Moffitt Cancer Center
ACTIVE_NOT_RECRUITING
Tampa
Louisiana
Mary Bird Perkins Cancer Ctr
RECRUITING
Baton Rouge
Massachusetts
Massachusetts General Hospital
ACTIVE_NOT_RECRUITING
Boston
Michigan
Karmanos Cancer Institute
WITHDRAWN
Detroit
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
Duke University Medical Center
COMPLETED
Durham
New York
New York Cancer & Blood Specialists - New Hyde Park
RECRUITING
New Hyde Park
New York Cancer and Blood Specialists-Central Park Hematology & Oncology
RECRUITING
New York
New York Cancer & Blood Specialists
RECRUITING
Port Jefferson Station
New York Cancer & Blood Specialists - Bronx
RECRUITING
The Bronx
Oregon
Hematology Oncology Salem
ACTIVE_NOT_RECRUITING
Salem
Pennsylvania
UPMC - Hillman Cancer Center
ACTIVE_NOT_RECRUITING
Pittsburgh
Tennessee
Sarah Cannon Research Institute / Tennessee Oncology
COMPLETED
Nashville
Vanderbilt University Medical Center
ACTIVE_NOT_RECRUITING
Nashville
Texas
Lumi Research
WITHDRAWN
Kingwood
Washington
Swedish Cancer Inst.
COMPLETED
Seattle
Medical Oncology Associates
WITHDRAWN
Spokane
Other Locations
Australia
Peter Maccallum Cancer Centre
RECRUITING
Melbourne
Canada
Jewish General Hospital
WITHDRAWN
Montreal
McGill University Health Center
WITHDRAWN
Montreal
Princess Margaret Cancer Center
ACTIVE_NOT_RECRUITING
Toronto
Denmark
Rigshospitalet, Onkologisk Klinik
RECRUITING
København Ø
Germany
Charité Universitätsmedizin Berlin
RECRUITING
Berlin
Katholisches Klinikum Bochum gGmbH - St. Josef-Hospital
RECRUITING
Bochum
Universitätsklinik Carl Gustav Carus der Technischen Universität Dresden
RECRUITING
Dresden
Universitätsklinikum Düsseldorf
RECRUITING
Düsseldorf
Asklepios Klinik Altona
RECRUITING
Hamburg
SLK-Kliniken Heilbronn GmbH;Klinik für Innere Medizin III
RECRUITING
Heilbronn
Klinikum der Universität München, Campus Großhadern
RECRUITING
München
Universitätsklinikum Ulm
RECRUITING
Ulm
Italy
Azienda Socio Sanitaria Territoriale Niguarda (Ospedale Niguarda Ca' Granda)
RECRUITING
Milan
Irccs Istituto Nazionale Dei Tumori (Int)
RECRUITING
Milan
Università degli Studi della Campania Luigi Vanvitelli
RECRUITING
Napoli
IRCCS Istituto Oncologico Veneto (IOV)
RECRUITING
Padua
Policlinico Universitario Agostino Gemelli IRCCS
RECRUITING
Rome
Poland
Szpital Uniwersytecki w Krakowie, Oddzia? Kliniczny Kliniki Onkologii
SUSPENDED
Krakow
Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITING
Poznan
Narodowy Instytut Onkologii im. M. Sklodowskiej-Curie
SUSPENDED
Warsaw
Republic of Korea
National Cancer Center
RECRUITING
Goyang-si
Chonnam National University Hwasun Hospital
RECRUITING
Jeollanam-do
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Vall d?Hebron Institute of Oncology (VHIO), Barcelona
RECRUITING
Barcelona
START Madrid-FJD, Hospital Fundacion Jimenez Diaz
RECRUITING
Madrid
START Madrid. Centro Integral Oncologico Clara Campal
WITHDRAWN
Madrid
Hospital Clínico Universitario de Valencia
RECRUITING
Valencia
Taiwan
National Cheng Kung University Hospital
RECRUITING
Tainan City
Taipei Veterans General Hospital
RECRUITING
Taipei
National Taiwan University Hospital
RECRUITING
Zhongzheng Dist.
United Kingdom
Addenbrookes Hospital
RECRUITING
Cambridge
Velindre Cancer Centre
RECRUITING
Cardiff
Imperial College Healthcare NHS Trust
ACTIVE_NOT_RECRUITING
London
Royal Free Hospital
SUSPENDED
London
Royal Marsden Hospital;Dept of Med-Onc
RECRUITING
London
Sarah Cannon Research Institute
ACTIVE_NOT_RECRUITING
London
The Christie NHS Foundation Trust
RECRUITING
Manchester
Royal Marsden Hospital
RECRUITING
Sutton
Contact Information
Primary
Reference Study ID Number: WO42758 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S. and Canada)
Time Frame
Start Date: 2021-10-22
Estimated Completion Date: 2028-11-07
Participants
Target number of participants: 542
Treatments
Experimental: Inavolisib + Cetuximab
Participants will receive 9 milligrams (mg) of inavolisib by mouth once daily (QD) on Days 8-28 of Cycle 1, then QD on Days 1-28 from Cycle 2 onwards (1 cycle=28 days).~Participants will also receive cetuximab intravenous (IV) infusion 400 mg/m2 body surface area on Day 1 of Cycle 1. All subsequent weekly (QW) doses will be 250 mg/m2 each. This arm is active, and not recruiting participants.
Experimental: Inavolisib + Bevacizumab
Participants will receive 9 mg of inavolisib by mouth QD combined with bevacizumab 15 milligram/kilogram (mg/kg) IV once every three weeks (Q3W) on Day 1 of each cycle (1 cycle=21 days). This arm is active, and not recruiting participants.
Experimental: Atezolizumab + Tiragolumab + Bevacizumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle, combined with tiragolumab at a dose of 600 mg IV infusion on Day 1 of each cycle and bevacizumab IV infusion at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
Experimental: Atezolizumab + Tiragolumab
Participants in this randomized cohort will receive 1200 mg of atezolizumab by IV infusion on Day 1 of each cycle combined with tiragolumab 600 mg IV infusion on Day 1 of each cycle. (Cycle length=21 days) This arm is active, and not recruiting participants.
Experimental: Atezolizumab + SY-5609
Participants will receive 1680 mg of atezolizumab by IV infusion on Day 1 of each cycle Q4W in repeated 28-day cycles combined with SY-5609 at a dose of 3, 4, 5, 6, 7 or 10 mg by mouth for 7 days, followed by 7 days off. (Cycle length=28 days) This arm is closed.
Experimental: Divarasib + Cetuximab + FOLFOX
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFOX on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Experimental: Divarasib + Cetuximab
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
Experimental: Divarasib + Cetuximab + FOLFIRI
Participants will receive cetuximab IV 500 mg/m2 body surface area on Days 1 and 15 and FOLFIRI on Days 1 and 15 with divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is active, and not recruiting participants.
Experimental: Divarasib + Bevacizumab + FOLFOX
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFOX on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Experimental: Divarasib + Bevacizumab + FOLFIRI
Participants will receive Bevacizumab 5 mg/kg by IV infusion on Days 1 and 15 and FOLFIRI on Days 1 and 15 with Divarasib PO QD on Days 1-28. (Cycle length=28 days) This arm is recruiting participants.
Related Therapeutic Areas
Sponsors
Leads: Hoffmann-La Roche

This content was sourced from clinicaltrials.gov