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Sotorasib Activity in Subjects With Advanced Solid Tumors With KRAS p.G12C Mutation (CodeBreak 101)

Program Status

Recruiting

Phase

PHASE1

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

No

Drugs

afatinib, AMG 404, Atezolizumab, carboplatin, pemetrexed, docetaxel, everolimus, FOLFIRI, FOLFOX, MVASI® (bevacizumab-awwb), palbociclib, panitumumab, Pembrolizumab, RMC-4630, Sotorasib, TNO155, Trametinib

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

Combination of targeted-to-the-mutation therapy PLUS several other anti-cancer therapies (targeted therapies and chemotherapies, in the case of the arms of the trial that admit CRC patients).
AMG 510: targeted therapy against the KRAS G12C mutation.
Only key inclusion criteria listed in the trial record:
Having a locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing.
(NO mention of prior immunotherapy, prior targeted therapy, measurable or just evaluable disease, how many lines of prior therapy required, etc.)
AMG 510 monotherapy: minimal activity in CRC (NCT03600883; see Helpful Links), hence the combinations tested in this trial.

Early data from this trial’s phase 1b dose exploration (n=8) and expansion (n=18) cohorts showed promising antitumor activity for the combination of Soto and panitumumab (Pmab) (see Helpful Links)

Location Location Status
United States
Arizona Oncology Associates Professional Corporation
Tucson, Arizona 85711
RECRUITING
City of Hope National Medical Center
Duarte, California 91010
RECRUITING
University of California San Diego Moores Cancer Center
La Jolla, California 92093
COMPLETED
Loma Linda University Cancer Center
Loma Linda, California 92354
RECRUITING
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles, California 90033
RECRUITING
University of California Davis Medical Center
Sacramento, California 95817
RECRUITING
University of California at SF
San Francisco, California 94115
RECRUITING
University of California Los Angeles
Santa Monica, California 90404
RECRUITING
Rocky Mountain Cancer Centers Denver Midtown
Denver, Colorado 80218
RECRUITING
Sarah Cannon Research Institute at HealthONE
Denver, Colorado 80218
RECRUITING
Yale Cancer Center
New Haven, Connecticut 06520
RECRUITING
Norwalk Hospital
Norwalk, Connecticut 06856
RECRUITING
Memorial Cancer Institute
Pembroke Pines, Florida 33028
RECRUITING
Moffitt Cancer Center
Tampa, Florida 33612
RECRUITING
Emory University
Atlanta, Georgia 30322
RECRUITING
Northwestern University
Chicago, Illinois 60637
RECRUITING
University of Chicago Medical Center
Chicago, Illinois 60637
RECRUITING
Indiana University
Indianapolis, Indiana 46202
RECRUITING
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242
RECRUITING
Johns Hopkins Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland 21224
RECRUITING
University of Michigan
Ann Arbor, Michigan 48109-5912
RECRUITING
Henry Ford Health System
Detroit, Michigan 48202
RECRUITING
Washington University
Saint Louis, Missouri 63110-1093
RECRUITING
Montefiore Medical Center
Bronx, New York 10461
TERMINATED
Roswell Park Cancer Institute
Buffalo, New York 32224
RECRUITING
Icahn School of Medicine at Mount Sinai
New York, New York 10029
COMPLETED
Columbia University Medical Center
New York, New York 10032
RECRUITING
Memorial Sloan Kettering Cancer Center
New York, New York 10065
RECRUITING
Levine Cancer Institute
Charlotte, North Carolina 28204
RECRUITING
Duke University Medical Center
Durham, North Carolina 27710
RECRUITING
University of Cincinnati Medical Center
Cincinnati, Ohio 45267
RECRUITING
Cleveland Clinic
Cleveland, Ohio 44195
TERMINATED
Providence Portland Medical Center
Portland, Oregon 97213
COMPLETED
Oregon Health and Science University
Portland, Oregon 97239
RECRUITING
Thomas Jefferson University
Philadelphia, Pennsylvania 19107
RECRUITING
Fox Chase Cancer Center
Philadelphia, Pennsylvania 19111
TERMINATED
University of Pennsylvania
Philadelphia, Pennsylvania 19111
RECRUITING
University of Pittsburgh Medical Center Cancer Pavillion
Pittsburgh, Pennsylvania 15232
RECRUITING
Gibbs Cancer Center and Research Institute - Spartanburg
Spartanburg, South Carolina 29303
RECRUITING
Avera Cancer Institute
Sioux Falls, South Dakota 57108
TERMINATED
Henry Joyce Cancer Center
Nashville, Tennessee 37232
RECRUITING
Texas Oncology - Austin Midtown
Austin, Texas 78705
RECRUITING
Mary Crowley Cancer Research
Dallas, Texas 75230
RECRUITING
University of Texas Southwestern Medical Center
Dallas, Texas 75390
RECRUITING
Oncology Consultants
Houston, Texas 77030
RECRUITING
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
RECRUITING
United States Oncology Regulatory Affairs Corporate Office
The Woodlands, Texas 77380
RECRUITING
US Oncology Research Investigational Products Center
The Woodlands, Texas 77380
RECRUITING
Texas Oncology Northeast Texas
Tyler, Texas 75702
TERMINATED
Huntsman Cancer Institute
Salt Lake City, Utah 84112
RECRUITING
University of Virginia
Charlottesville, Virginia 22903
RECRUITING
Virginia Cancer Specialists, PC
Fairfax, Virginia 22031
RECRUITING
Fred Hutchinson Cancer Center
Seattle, Washington 98109
RECRUITING
Northwest Medical Specialties, PLLC
Tacoma, Washington 98405
RECRUITING
Northwest Cancer Specialists - Vancouver
Vancouver, Washington 98684
COMPLETED
Australia
Nepean Cancer Centre
Kingswood, New South Wales 2747
RECRUITING
GenesisCare -North Shore Oncology
St Leonards, New South Wales 2065
RECRUITING
Icon Cancer Care South Brisbane
South Brisbane, Queensland 4101
RECRUITING
The Queen Elizabeth Hospital
Woodville South, South Australia 5011
RECRUITING
St John of God Healthcare
Subiaco, Western Australia 6008
RECRUITING
Austria
Medizinische Universitaet Graz
Graz 8036
RECRUITING
Landeskrankenhaus Salzburg
Salzburg 5020
RECRUITING
Belgium
Universite Catholique de Louvain Cliniques Universitaires Saint Luc
Bruxelles 1200
RECRUITING
Universitair Ziekenhuis Antwerpen
Edegem 2650
RECRUITING
Canada
CHU de Quebec Hopital de l Enfant Jesus
Quebec G1J 1Z4
RECRUITING
Germany
Charite Universitaetsmedizin Berlin, Campus Virchow
Berlin 13353
COMPLETED
Universitaetsklinikum Dresden
Dresden 01307
COMPLETED
Universitaetsklinikum Essen
Essen 45147
RECRUITING
Universitatsklinikum Koln
Koeln 50937
RECRUITING
Italy
Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda
Milano 20162
RECRUITING
Azienda Ospedaliero Universitaria Pisana
Pisa 56126
RECRUITING
Centro Ricerche Cliniche Di Verona Societa responsabilita limitata
Verona 37126
RECRUITING
Japan
Aichi Cancer Center
Nagoya-shi, Aichi 464-8681
RECRUITING
National Cancer Center Hospital East
Kashiwa-shi, Chiba 277-8577
RECRUITING
The Cancer Institute Hospital of Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
RECRUITING
Korea, Republic of
Seoul National University Hospital
Seoul 03080
COMPLETED
The Catholic University of Korea Seoul St Marys Hospital
Seoul 06591
RECRUITING
Asan Medical Center
Seoul 138-736
RECRUITING
Netherlands
Universitair Medisch Centrum Utrecht
Utrecht 3584 CX
RECRUITING
Spain
Hospital Universitari Vall d Hebron
Barcelona, Cataluña 08035
RECRUITING
Hospital Clinic i Provincial de Barcelona
Barcelona, Cataluña 08036
RECRUITING
Institut Catala d Oncologia Hospitalet Hospital Duran i Reynals
Hospitalet de Llobregat, Cataluña 08908
RECRUITING
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid 28222
RECRUITING
Hospital Universitario Ramon y Cajal
Madrid 28034
RECRUITING
Hospital Universitario 12 de Octubre
Madrid 28041
RECRUITING
Taiwan
National Cheng Kung University Hospital
Tainan 70403
RECRUITING
National Taiwan University Hospital
Taipei 10002
RECRUITING
Taipei Veterans General Hospital
Taipei 11217
RECRUITING
Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation
Taoyuan 33305
RECRUITING
United Kingdom
Sarah Cannon Research Institute UK
London W1G 6AD
RECRUITING

Contacts

Amgen Call Center
CONTACT
866-572-6436 medinfo@amgen.com

Inclusion Criteria

Inclusion Criteria:

* Men or women greater than or equal to 18 years old.
* Pathologically documented, locally-advanced or metastatic malignancy with, KRAS p.G12C mutation identified through molecular testing performed according to in-country requirements. In the United States, this test must be performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory.

Exclusion Criteria

Exclusion Criteria:

* Primary brain tumor.
* Spinal cord compression, or untreated, or symptomatic, or active brain metastases, or leptomeningeal disease from non-brain tumors.
* Myocardial infarction within 6 months of study day 1.
* Gastrointestinal (GI) tract disease causing the inability to take oral medication.

NCT ID

NCT04185883

Date Trial Added

2019-12-04

Updated Date

2024-06-27