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Search / Trial NCT06252649

Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation

Launched by AMGEN · Feb 8, 2024

Trial Information

Current as of July 22, 2025

Recruiting

Keywords

Sotorasib Panitumumab Folfiri Bevacizumab Awwb Oncology

ClinConnect Summary

This clinical trial is studying a new treatment approach for patients with metastatic colorectal cancer that has a specific genetic change known as the KRAS p.G12C mutation. Researchers want to see if combining three medications—sotorasib, panitumumab, and FOLFIRI—works better than the standard treatment of FOLFIRI alone or with another drug called bevacizumab. The main goal is to find out if this new combination can help patients live longer without their cancer getting worse.

To participate in this trial, you must have a confirmed diagnosis of metastatic colorectal cancer with the KRAS p.G12C mutation. Other requirements include having measurable cancer that meets specific criteria and being in fairly good overall health. If you join, you will receive either the new treatment combination or the standard treatment for comparison. This study is currently looking for participants, and it welcomes individuals aged 65 and older, regardless of gender. It's an important step in exploring better options for patients facing this challenging condition.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.
  • Central confirmation of KRAS p.G12C mutation
  • Measurable metastatic disease per RECIST v1.1 criteria.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.
  • Adequate organ function.
  • Exclusion Criteria:
  • Active, untreated brain metastases.
  • Leptomeningeal disease
  • Previous treatment with a KRAS p.G12C inhibitor
  • History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan

About Amgen

Amgen is a leading global biotechnology company dedicated to discovering, developing, manufacturing, and delivering innovative human therapeutics. With a strong focus on areas such as oncology, cardiovascular disease, and inflammation, Amgen leverages advanced science and technology to address complex medical needs. The company is committed to improving patient outcomes through rigorous clinical trials and robust research initiatives, ensuring the highest standards of safety and efficacy in its products. With a rich pipeline of cutting-edge therapies, Amgen continues to be at the forefront of biopharmaceutical advancements, making a significant impact on healthcare worldwide.

Locations

Nice, , France

Copenhagen, , Denmark

Bangkok, , Thailand

Madrid, , Spain

Madrid, , Spain

Paris, , France

Detroit, Michigan, United States

Sapporo, Hokkaido, Japan

Atlanta, Georgia, United States

Philadelphia, Pennsylvania, United States

Enschede, , Netherlands

Woodville South, South Australia, Australia

Toowoomba, Queensland, Australia

Essen, , Germany

Bedford Park, South Australia, Australia

Norwalk, Connecticut, United States

Maidstone, , United Kingdom

Odense C, , Denmark

Santander, Cantabria, Spain

Granada, , Spain

Gent, , Belgium

Chuo Ku, Tokyo, Japan

Seoul, , Korea, Republic Of

Cordoba, , Spain

Taichung, , Taiwan

Taichung, , Taiwan

Sevilla, , Spain

Creteil, , France

Seoul, , Korea, Republic Of

Athens, , Greece

Athens, , Greece

Seoul, , Korea, Republic Of

Izmir, , Turkey

Seoul, , Korea, Republic Of

Wolfsburg, , Germany

Brno, , Czechia

Rock Hill, South Carolina, United States

Niigata Shi, Niigata, Japan

Sunto Gun, Shizuoka, Japan

Monterrey, , Mexico

Buenos Aires, , Argentina

Praha 10, , Czechia

Barcelona, , Spain

Ploiesti, , Romania

Bucharest, , Romania

Cordoba, , Argentina

Dresden, , Germany

Budapest, , Hungary

Lyon, , France

Praha 5, , Czechia

Northwood, , United Kingdom

Graz, , Austria

Ulm, , Germany

Tallinn, , Estonia

Hradec Kralove, , Czechia

Santiago, , Chile

Pikeville, Kentucky, United States

Aarhus N, , Denmark

Grand Rapids, Michigan, United States

Pisa, , Italy

Chemnitz, , Germany

Brescia, , Italy

Elche, Comunidad Valenciana, Spain

Taipei, , Taiwan

Aalborg, , Denmark

Paris Cedex 10, , France

Milano, , Italy

Larissa, , Greece

Jacksonville, Florida, United States

Skokie, Illinois, United States

Firenze, , Italy

Nashville, Tennessee, United States

Maastricht, , Netherlands

London, , United Kingdom

Zuerich, , Switzerland

Kowloon, , Hong Kong

Burgos, , Spain

Seoul, , Korea, Republic Of

Yokohama Shi, Kanagawa, Japan

Iasi, , Romania

Malaga, , Spain

Camperdown, New South Wales, Australia

Suita Shi, Osaka, Japan

Debrecen, , Hungary

Durham, North Carolina, United States

Monterrey, Nuevo León, Mexico

Hong Kong, , Hong Kong

Madrid, , Spain

Coimbra, , Portugal

Poitiers Cedex, , France

Oviedo, Asturias, Spain

Piraeus, , Greece

Montpellier Cedex 5, , France

Fukuoka Shi, Fukuoka, Japan

Olomouc, , Czechia

Heidelberg, Victoria, Australia

Paris Cedex 13, , France

Wien, , Austria

Thessaloniki, , Greece

Valencia, Comunidad Valenciana, Spain

Itajai, Santa Catarina, Brazil

Chiba Shi, Chiba, Japan

Tokushima Shi, Tokushima, Japan

Matsuyama Shi, Ehime, Japan

Cluj Napoca, , Romania

Plovdiv, , Bulgaria

Pamplona, Navarra, Spain

Kashiwa Shi, Chiba, Japan

Koto Ku, Tokyo, Japan

Bruxelles, , Belgium

Barcelona, Cataluña, Spain

Seoul, , Korea, Republic Of

Lisboa, , Portugal

Valencia, Comunidad Valenciana, Spain

Los Angeles, California, United States

Reims, , France

Sevilla, Andalucía, Spain

Rennes Cedex 9, , France

Ourense, Galicia, Spain

Rankweil, , Austria

Brasilia, Distrito Federal, Brazil

Berlin, , Germany

Hirakata Shi, Osaka, Japan

Milano, , Italy

Sofia, , Bulgaria

Athens, , Greece

Timisoara, , Romania

Genova, , Italy

São José Do Rio Preto, , Brazil

Kitaadachi Gun, Saitama, Japan

Istanbul, , Turkey

Leuven, , Belgium

Goyang Si, Gyeonggi Do, , Korea, Republic Of

Seoul, , Korea, Republic Of

Los Alamitos, California, United States

Malatya, , Turkey

Orange City, Florida, United States

Teresina, Piauí, Brazil

Thessaloniki, , Greece

Matosinhos, , Portugal

Ankara, , Turkey

Edirne, , Turkey

La Rioja, , Argentina

Haskovo, , Bulgaria

Barcelona, Cataluña, Spain

Brussels, , Belgium

Roeselare, , Belgium

São José Do Rio Preto, São Paulo, Brazil

Nagoya Shi, Aichi, Japan

Kawasaki Shi, Kanagawa, Japan

Yokohama Shi, Kanagawa, Japan

Goyang Si Gyeonggi Do, , Korea, Republic Of

Foggia, , Italy

Porto Alegre, Rio Grande Do Sul, Brazil

Valdivia, , Chile

Taoyuan, , Taiwan

Istanbul, , Turkey

Linz, , Austria

Cordoba, Andalucía, Spain

Barcelona, , Spain

Sofia, , Bulgaria

Temuco, Cautín, Chile

Lisboa, , Portugal

Akashi Shi, Hyogo, Japan

Athens, , Greece

Birmingham, , United Kingdom

Praha 8, , Czechia

Amsterdam, , Netherlands

Viedma, Río Negro, Argentina

Burgos, Castilla León, Spain

Lisboa, , Portugal

Ciudad Autonoma De Buenos Aires, Buenos Aires, Argentina

Natal, Rio Grande Do Norte, Brazil

Providencia, Santiago, Chile

Granada, Andalucía, Spain

San Miguel De Tucuman, Tucuman, Argentina

Ijui, Rio Grande Do Sul, Brazil

Verona, , Italy

Poznan, , Poland

Bucuresti, , Romania

Malaga, Andalucía, Spain

Osaka Shi, Osaka, Japan

Mechelen, , Belgium

Palermo, , Italy

São Paulo, , Brazil

Mexico City, Distrito Federal, Mexico

Thessaloniki, , Greece

Barretos, São Paulo, Brazil

Temuco, , Chile

Viedma, , Argentina

Castellana Grotte, , Italy

Ankara, , Turkey

Rio De Janeiro, , Brazil

Kaposvar, , Hungary

Hinsdale, Illinois, United States

Plovdiv, , Bulgaria

Nyiregyhaza, , Hungary

Gyula, , Hungary

Ankara, , Turkey

Ludwigsburg, , Germany

Craiova, , Romania

Muenchen, , Germany

Pinehurst, North Carolina, United States

Ankara, , Turkey

Cachoeiro De Itapemirim, , Brazil

Thessaloniki, , Greece

Sao Paulo, São Paulo, Brazil

Istanbul, , Turkey

Fullerton, California, United States

Sint Niklaas, , Belgium

Floridablanca, Santander, Colombia

Santiago, , Chile

Adana, , Turkey

São Paulo, , Brazil

Szolnok, , Hungary

Rionegro, Antioquia, Colombia

Udine, , Italy

Lisboa, , Portugal

Coimbra, , Portugal

Santa Maria Da Feira, , Portugal

Almada, , Portugal

Kielce, , Poland

Margate, Florida, United States

Jacksonville, Florida, United States

Saint Priest En Jarez, , France

Bogotá, Cundinamarca, Colombia

Hong Kong, , Hong Kong

Kanagawa, Yokohama, Japan

Taichung City, Xitun District, Taiwan

Plantation, Florida, United States

Bridgeton, Missouri, United States

Mickleton, New Jersey, United States

Caba, Buenos Aires, Argentina

Caba, Buenos Aires, Argentina

Cordoba, Córdoba, Argentina

Konya, , Turkey

Chandler, Arizona, United States

La Plata, Buenos Aires, Argentina

San Miguel De Tucuman, Tucuman, Argentina

Cordoba, Córdoba, Argentina

Mar Del Plata, Buenos Aires, Argentina

Cachoeiro De Itapemirim, Espírito Santo, Brazil

Sao Paulo, São Paulo, Brazil

Bogota, Cundinamarca, Colombia

Barretos, São Paulo, Brazil

Porto Alegre, Rio Grande Do Sul, Brazil

Montería, Córdoba, Colombia

Las Condes, Santiago, Chile

Frankfurt Am Main, , Germany

Hamburg, , Germany

Caba, Buenos Aires, Argentina

Vitacura, Santiago, Chile

Montería, Córdoba, Colombia

Benito Juárez, Distrito Federal, Mexico

Stockholm, , Sweden

Clermont Ferrand Cedex 1, , France

Dijon Cedex, , France

Suita Shi, Osaka, Japan

Santiago, , Chile

Vandoeuvre Les Nancy Cedex, , France

Cordoba, Córdoba, Argentina

Charleroi, , Belgium

Pessac, , France

Saint Herblain Cedex, , France

Temuco, Cautín, Chile

Santiago, , Chile

Nashville, Tennessee, United States

Cordoba, , Argentina

Warszawa, , Poland

Pesaro, , Italy

Barretos, , Brazil

Teresina, , Brazil

Badalona, , Spain

Sao Paulo, , Brazil

Cordoba, , Argentina

Barretos, , Brazil

Sao Paulo, , Brazil

Temuco, , Chile

Montería, , Colombia

Medellin, Antioquia, Colombia

Opole, , Poland

Stockholm, , Sweden

Patients applied

0 patients applied

Trial Officials

MD

Study Director

Amgen

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported