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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

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)

Helpful Links

https://www.annalsofoncology.org/article/S0923-7534(22)04268-5/fulltext

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 San Francisco Mission Bay Campus 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 Denver, Colorado 80218	Recruiting
Yale New Haven Hospital New Haven, Connecticut 06520	Recruiting
Norwalk Hospital Norwalk, Connecticut 06856	Recruiting
Memorial Cancer Institute Pembroke Pines, Florida 33028	Completed
Moffitt Cancer Center Tampa, Florida 33612	Recruiting
Emory University Atlanta, Georgia 30322	Recruiting
Northwestern University Chicago, Illinois 60611	Recruiting
University of Chicago Chicago, Illinois 60637	Recruiting
Indiana University Indianapolis, Indiana 46202	Recruiting
University of Iowa Hospitals and Clinics Iowa City, Iowa 52242	Recruiting
Johns Hopkins University Baltimore, Maryland 21224	Recruiting
University of Michigan Ann Arbor, Michigan 48109-5912	Recruiting
Henry Ford Cancer Detroit (Brigitte Harris Cancer Pavilion) 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	Completed
Icahn School of Medicine at Mount Sinai New York, New York 10029	Completed
Columbia University Irving 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 Durham, North Carolina 27710	Recruiting
University of Cincinnati Medical Center Cincinnati, Ohio 45267	Completed
Cleveland Clinic Foundation 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 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
Vanderbilt University Medical Center Nashville, Tennessee 37232	Terminated
Texas Oncology Central-South Austin, Texas 78705	Recruiting
Mary Crowley Cancer Research Dallas, Texas 75230	Completed
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 Cancer Center 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	Terminated
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	Completed
Asan Medical Center Seoul 138-736	Completed
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

2025-03-25