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A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)

Program Status

Active, not recruiting

Phase

Phase 1 Phase 2

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Drugs

Anti PD-1/L1, Midazolam, Sotorasib

Tags

MSS/ MMRp

Comments

Key inclusion/ exclusion criteria: patient needs to have a KRAS p.G12C mutation
Measurable or EVALUABLE disease –non measurable– acceptable.
For the first part –Part 1 (Dose Exploration); that is, no–, archived tumor samples are ok, or undergoing a biopsy too.
Need to have received some prior treatment
Subject able to eat a standardized high-fat, high-caloric meal within 25 minutes Subject able to fast for greater than or equal to 10 hours Subject able to handle collection of his/her urine over a 24 hour period.
Update sept 19: minimal activity as monotherapy in CRC (ESMO;see Helpful Links). DEC19: new trial in combination with immunotherapy: NCT04185883

Location	Location Status
United States
City of Hope National Medical Center Duarte, California 91010	Active, not recruiting
University of California Los Angeles Los Angeles, California 90095	Active, not recruiting
University of California at SF San Francisco, California 94115	Active, not recruiting
Sarcoma Oncology Research Center LLC Santa Monica, California 90403	Active, not recruiting
Rocky Mountain Cancer Centers Denver, Colorado 80218	Active, not recruiting
Sarah Cannon Research Institute at HealthONE Denver, Colorado 80218	Active, not recruiting
Smilow Cancer Hospital at Yale New Haven New Haven, Connecticut 06510	Active, not recruiting
Medical Oncology Hematology Consultants Helen F Graham Cancer Center Newark, Delaware 19713	Active, not recruiting
University of Florida Health Gainesville, Florida 32610	Active, not recruiting
AdventHealth Orlando Infusion Center Orlando, Florida 32804	Active, not recruiting
Moffitt Cancer Center Tampa, Florida 33612	Active, not recruiting
Winship Cancer Institute Atlanta, Georgia 30322	Active, not recruiting
Indiana University Indianapolis, Indiana 46202	Active, not recruiting
American Oncology Partners of Maryland, PA Bethesda, Maryland 20817	Active, not recruiting
Massachusetts General Hospital Boston, Massachusetts 02114	Active, not recruiting
Dana Farber Cancer Institute Boston, Massachusetts 02215	Active, not recruiting
University of Michigan Ann Arbor, Michigan 48109	Active, not recruiting
Henry Ford Health System Detroit, Michigan 48202	Active, not recruiting
Washington University St Louis, Missouri 63110-1093	Active, not recruiting
Roswell Park Cancer Institute Buffalo, New York 14263	Active, not recruiting
Laura and Isaac Perlmutter Cancer Center at New York University Langone New York, New York 10016	Active, not recruiting
Memorial Sloan Kettering Cancer Center New York, New York 10065	Active, not recruiting
Duke University Medical Center, Morris Cancer Clinic Durham, North Carolina 27710	Active, not recruiting
University Hospitals Cleveland Medical Center Cleveland, Ohio 44106	Active, not recruiting
Cleveland Clinic Cleveland, Ohio 44195	Active, not recruiting
University of Pennsylvania Philadelphia, Pennsylvania 19104	Active, not recruiting
Fox Chase Cancer Center Philadelphia, Pennsylvania 19111	Active, not recruiting
University of Pittsburgh Medical Center Cancer Pavillion Pittsburgh, Pennsylvania 15232	Active, not recruiting
Gibbs Cancer Center and Research Institute - Spartanburg Spartanburg, South Carolina 29303	Active, not recruiting
Vanderbilt University Ingram Cancer Center Nashville, Tennessee 37232	Active, not recruiting
Texas Oncology - Austin Central Austin, Texas 78731	Active, not recruiting
Texas Oncology - Baylor Dallas, Texas 75246	Active, not recruiting
University of Texas Southwestern Medical Center Dallas, Texas 75390	Active, not recruiting
University of Texas MD Anderson Cancer Center Houston, Texas 77030	Active, not recruiting
Huntsman Cancer Institute Salt Lake City, Utah 84112	Active, not recruiting
US Oncology Research Investigational Products Center Fairfax, Virginia 22031	Active, not recruiting
Virginia Cancer Specialists PC Fairfax, Virginia 22031	Active, not recruiting
Blue Ridge Cancer Care Salem, Virginia 24153	Active, not recruiting
Seattle Cancer Care Alliance Seattle, Washington 98109	Active, not recruiting
Australia
Scientia Clinical Research Ltd Randwick, New South Wales 2031	Active, not recruiting
Princess Alexandra Hospital Woolloongabba, Queensland 4102	Active, not recruiting
The Queen Elizabeth Hospital Woodville South, South Australia 5011	Active, not recruiting
Peter MacCallum Cancer Centre Parkville, Victoria 3050	Active, not recruiting
Austria
Medizinische Universitaet Graz Graz 8036	Active, not recruiting
Medizinische Universitaet Innsbruck Innsbruck 6020	Active, not recruiting
Universitaetsklinikum Krems Krems 3500	Active, not recruiting
Universitaetsklinikum Allgemeines Krankenhaus Wien Vienna 1090	Active, not recruiting
Krankenhaus Nord - Klinik Floridsdorf Vienna 1210	Active, not recruiting
Belgium
Institut Jules Bordet Brussels B-1070	Active, not recruiting
Grand Hopital de Charleroi Charleroi 6000	Active, not recruiting
Universitair Ziekenhuis Antwerpen Edegem 2650	Active, not recruiting
Ziekenhuis Oost-Limburg Genk 3600	Active, not recruiting
Universitair Ziekenhuis Gent Ghent 9000	Active, not recruiting
Jessa Ziekenhuis - Campus Virga Jesse Hasselt 3500	Active, not recruiting
Universitair Ziekenhuis Leuven - Campus Gasthuisberg Leuven 3000	Active, not recruiting
Centre Hospitalier Universitaire de Liege Liège 4000	Active, not recruiting
AZ Delta Campus Rumbeke Roeselare 8800	Active, not recruiting
Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre, Nucleo de Novos Tratamentos em Cancer Porto Alegre, Rio Grande do Sul 90050-170	Active, not recruiting
Hospital Sao Lucas da Pontificia Universidade Catolica do Rio Grande do Sul Porto Alegre, Rio Grande do Sul 90610-000	Active, not recruiting
Hospital de Base de Sao Jose do Rio Preto São José do Rio Preto, São Paulo 15090-000	Active, not recruiting
Sociedade Beneficente de Senhoras Hospital Sirio Libanes São Paulo, São Paulo 01308-050	Active, not recruiting
Oncologia Rede D´Or São Paulo, São Paulo 04501-000	Active, not recruiting
Instituto Coi Rio de Janeiro 20231-050	Active, not recruiting
Canada
Tom Baker Cancer Centre Calgary, Alberta T2N 4N2	Active, not recruiting
Cross Cancer Institute Edmonton, Alberta T6G 1Z2	Active, not recruiting
London Regional Cancer Program, London Health Sciences Centre London, Ontario N6A 5W9	Active, not recruiting
The Ottawa Hospital Cancer Centre Ottawa, Ontario K1H 8L6	Active, not recruiting
Princess Margaret Cancer Centre Toronto, Ontario M5G 2M9	Active, not recruiting
McGill University Health Centre Glen Site Montreal, Quebec H4A 3J1	Active, not recruiting
France
Institut Bergonie Bordeaux 33076	Active, not recruiting
Centre Hospitalier Intercommunal de Créteil Créteil 94010	Active, not recruiting
Hopital de la Timone Marseille 13385	Active, not recruiting
Institut Curie Paris 75005	Active, not recruiting
Institut Claudius Regaud Toulouse 31059	Active, not recruiting
Gustave Roussy Villejuif 94805	Active, not recruiting
Germany
Universitatsklinikum Koln Cologne 50937	Active, not recruiting
Universitätsklinikum Essen Essen 45147	Active, not recruiting
Klinikum der Universität München Campus Grosshadern München 81377	Active, not recruiting
Greece
Henry Dunant Hospital Center Athens 11526	Active, not recruiting
Metropolitan Hospital Athens 18547	Active, not recruiting
University Hospital of Heraklion Heraklion - Crete 71500	Active, not recruiting
Theagenion Cancer Hospital Thessaloniki 54007	Active, not recruiting
Agios Loukas Clinic Thessaloniki 55236	Active, not recruiting
Hungary
Semmelweis Egyetem Budapest 1083	Active, not recruiting
Orszagos Koranyi Pulmonologiai Intezet Budapest 1121	Active, not recruiting
Somogy Megyei Kaposi Mor Oktato Korhaz Kaposvár 7400	Active, not recruiting
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz Székesfehérvár 8000	Active, not recruiting
Szent Borbala Korhaz Tatabánya 2800	Active, not recruiting
Tudogyogyintezet Torokbalint Törökbálint 2045	Active, not recruiting
Japan
Aichi Cancer Center Nagoya, Aichi-ken 464-8681	Active, not recruiting
National Cancer Center Hospital East Kashiwa-shi, Chiba 277-8577	Active, not recruiting
National Hospital Organization Shikoku Cancer Center Matsuyama, Ehime 791-0280	Active, not recruiting
National Hospital Organization Kyushu Cancer Center Fukuoka, Fukuoka 811-1395	Active, not recruiting
National Hospital Organization Hokkaido Cancer Center Sapporo, Hokkaido 003-0804	Active, not recruiting
St Marianna University Hospital Kawasaki-shi, Kanagawa 216-8511	Active, not recruiting
Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center Yokohama, Kanagawa 241-8515	Active, not recruiting
Sendai Kousei Hospital Sendai, Miyagi 980-0873	Active, not recruiting
Niigata Cancer Center Hospital Niigata, Niigata 951-8566	Active, not recruiting
Okayama University Hospital Okayama, Okayama-ken 700-8558	Active, not recruiting
Kansai Medical University Hospital Hirakata-shi, Osaka 573-1191	Active, not recruiting
Osaka International Cancer Institute Osaka, Osaka 541-8567	Active, not recruiting
Shizuoka Cancer Center Sunto-gun, Shizuoka 411-8777	Active, not recruiting
The Cancer Institute Hospital of Japanese Foundation for Cancer Research Koto-ku, Tokyo 135-8550	Active, not recruiting
Wakayama Medical University Hospital Wakayama, Wakayama 641-8510	Active, not recruiting
Portugal
Fundacao Champalimaud Lisbon 1400-038	Active, not recruiting
Centro Hospitalar Universitario de Lisboa Norte EPE - Hospital Pulido Valente Lisbon 1769-001	Active, not recruiting
Unidade Local de Saude de Matosinhos, EPE - Hospital Pedro Hispano Matosinhos Municipality 4464-513	Active, not recruiting
Centro Hospitalar Universitario do Porto EPE - Hospital de Santo Antonio Porto 4099-001	Active, not recruiting
Hospital Cuf porto Porto 4100-180	Active, not recruiting
Romania
Institutul Oncologic, Prof Dr Alexandru Trestioreanu Bucharest 022328	Active, not recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca Cluj-Napoca 400015	Active, not recruiting
SC Medisprof SRL Cluj-Napoca 400641	Active, not recruiting
Centrul de Radioterapie Amethyst Cluj Cluj-Napoca 407280	Active, not recruiting
Centrul de Oncologie Sf Nectarie SRL Craiova 200347	Active, not recruiting
Institutul Regional de Oncologie Iasi Iași 700483	Active, not recruiting
Spitalul Municipal Ploiesti Ploieşti 100337	Active, not recruiting
SC Oncomed SRL Timișoara 300239	Active, not recruiting
South Korea
National Cancer Center Goyang-si Gyeonggi-do 10408	Active, not recruiting
Seoul National University Bundang Hospital Seongnam-si, Gyeonggi-do 13620	Active, not recruiting
Seoul National University Hospital Seoul 03080	Active, not recruiting
Severance Hospital Yonsei University Health System Seoul 03722	Active, not recruiting
Asan Medical Center Seoul 05505	Active, not recruiting
Samsung Medical Center Seoul 06351	Active, not recruiting
The Catholic University of Korea Seoul St Marys Hospital Seoul 06591	Active, not recruiting
Spain
Hospital Universitari Germans Trias i Pujol Badalona, Catalonia 08916	Active, not recruiting
Hospital General Universitario de Valencia Valencia, Valencia 46014	Active, not recruiting
Hospital General Universitario Gregorio Marañon Madrid 28009	Active, not recruiting
Clinica Universidad de Navarra Madrid 28027	Active, not recruiting
Fundacion Jimenez Diaz Madrid 28040	Active, not recruiting
Hospital Universitario Madrid Sanchinarro Madrid 28050	Active, not recruiting
Switzerland
Universitaetsspital Basel Basel 4031	Active, not recruiting
Hopitaux Universitaires de Geneve Geneva 1211	Active, not recruiting
Universitaetsspital Zuerich Zurich 8091	Active, not recruiting

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.

Exclusion Criteria

* Active brain metastases 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

NCT03600883

Date Trial Added

2018-07-26

Updated Date

2025-11-20