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New drug duo targets Hard-to-Treat colorectal cancer

NCT ID NCT05198934

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 23, 2026 · Updated 2 times

Summary

This phase 3 trial tested whether combining sotorasib (a pill) and panitumumab (an infusion) can slow tumor growth better than standard chemotherapy in 160 adults with metastatic colorectal cancer that has a specific KRAS G12C mutation. Participants were randomly assigned to receive the combo or one of two standard drugs. The main goal was to see how long the cancer stayed under control.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
sotorasib and panitumumab
What this could lead to
If successful, this combination could offer a new targeted treatment option for people with a specific genetic mutation in advanced colorectal cancer.
What could go wrong
This is a completed phase 3 trial, but results are not yet widely available. The treatment may not improve survival or could cause side effects like skin reactions or infusion reactions.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

160 people

The number who actually took part.

Started

Apr 2022

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 100 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participant has provided informed consent/assent prior to initiation of any study specific activities/procedures. * Age ≥18 years. * Pathologically documented metastatic colorectal adenocarcinoma with Kirsten rat sarcoma (KRAS) p.G12C mutation as determined by prospective central testing, using the analytically validated Qiagen Therascreen KRAS RGQ polymerase chain reaction Kit in CRC as an investigational device demonstrating a KRAS p.G12C mutation is present. Local testing and documentation of KRAS p.G12C mutation should have been previously performed as part of standard of care. * Participants will have received at least 1 prior line of therapy for metastatic disease. Participants must have received and progressed or experienced disease recurrence on or after fluoropyrimidine, irinotecan, and oxaliplatin given for metastatic disease unless the participant, in the opinion of the investigator, is not a candidate for fluoropyrimidine, irinotecan, or oxaliplatin, in which case, the participant may be eligible after investigator discussion with Amgen medical monitor provided participant has received at least one prior line of therapy for metastatic disease and provided trifluridine and tipiracil or regorafenib is deemed the appropriate next line of therapy for the participant. * Measurable disease per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 criteria. Lesions previously radiated are not considered measurable unless they have progressed after radiation. * Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤2. * Life expectancy of \>3 months, in the opinion of the investigator. * Adequate hematologic and end-organ function, defined as the following within 2 weeks prior to cycle 1 day 1: * Absolute neutrophil count (ANC) ≥1.5 x 10\^9/L (without granulocyte colony stimulating factor support within 2 weeks of laboratory test used to determine eligibility). * Hemoglobin ≥9.0 g/dL (without transfusion within 2 weeks of laboratory test used to determine eligibility). * Platelet count ≥100 x 10\^9/L (without transfusion within 2 weeks of laboratory test used to determine eligibility). * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 times the upper limit of normal (ULN). * Serum bilirubin ≤1.0 x ULN. For participants with Gilbert's disease, total bilirubin or direct bilirubin needs to be ≤1.0 x ULN. * International normalized ratio (INR) and activated partial thromboplastin time (or partial thromboplastin time) ≤1.5 x ULN. Prothrombin time (PT) ≤1.5 x ULN may be used instead of INR for sites whose labs do not report INR. * Estimated glomerular filtration rate based on Modification of Diet in Renal Disease (MDRD) calculation ≥30 mL/min/1.73 m\^2. * Fridericia's Correction Formula (QTcF) ≤470 msec. Exclusion Criteria: * Active brain metastases. Participants who have had brain metastases resected or have received radiation therapy ending at least 4 weeks prior to study day 1 are eligible if they meet all of the following criteria: a) residual neurological symptoms grade ≤2; b) on stable doses of dexamethasone or equivalent for at least 2 weeks, if applicable; and c) follow-up magnetic resonance imaging (MRI) performed within 28 days of day 1 shows no progression or new lesions appearing. * History or presence of hematological malignancies unless curatively treated with no evidence of disease ≥2 years. * History of other malignancy within the past 3 years, with the following exceptions: * Malignancy treated with curative intent and with no known active disease present for ≥3 years before enrollment and felt to be at low risk for recurrence by the treating physician. * Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. * Adequately treated cervical carcinoma in situ without evidence of disease. * Adequately treated breast ductal carcinoma in situ without evidence of disease. * Prostatic intraepithelial neoplasia without evidence of prostate cancer. * Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ. * Leptomeningeal disease. * Significant gastrointestinal (GI) disorder that results in significant malabsorption, requirement for intravenous (IV) alimentation, or inability to take oral medication. * History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis. * Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within 6 months prior to randomization, unstable arrhythmias or unstable angina. * Previous treatment with a KRAS G12C inhibitor.

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Conditions

The condition(s) this trial relates to.

colorectal adenocarcinoma colorectal cancer colorectal neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colorectal cancer (CRC)

Contacts and locations

Locations

  • Agios Loukas Clinic

    Thessaloniki, 55236, Greece

  • Aichi Medical University Hospital

    Nagakute-shi, Aichi-ken, 480-1195, Japan

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Cardinale Giovanni Panico

    Tricase, 73039, Italy

  • Azienda Ospedaliera Rilievo Nazionale e Alta Specializzazione Garibaldi Nesima

    Catania, 95122, Italy

  • Azienda Ospedaliera San Carlo

    Potenza, 85100, Italy

  • Azienda Ospedaliera San Giovanni Addolorata

    Roma, 00184, Italy

  • Azienda Ospedaliera Santa Croce e Carle

    Confreria (CN), 12100, Italy

  • Azienda Ospedaliera Universitaria Careggi

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Pisana Ospedale Santa Chiara

    Pisa, 56126, Italy

  • Azienda Ospedaliero Universitaria Luigi Vanvitelli

    Naples, 80131, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carita

    Novara, 28100, Italy

  • Azienda Ospedaliero Universitaria di Cagliari Policlinico Duilio Casula

    Monserrato CA, 09042, Italy

  • Azienda Sanitaria Locale 5 Spezzino Ospedale S Andrea

    La Spezia, 19100, Italy

  • Azienda Socio Sanitaria Territoriale Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Azienda Unita Locale Socio Sanitaria Berica 8

    Vicenza, 36100, Italy

  • Azienda Unita Sanitaria Locale LE Presidio Ospedaliero Vito Fazzi Polo Oncologico Giovanni Paolo II

    Lecce, 73100, Italy

  • Azienda Unita Sanitaria Locale di Reggio Emilia Arcispedale Santa Maria Nuova

    Reggio Emilia, 42100, Italy

  • Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YN, United Kingdom

  • Best Cancer Care & Hematology

    Houston, Texas, 77089, United States

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256, United States

  • Central Alabama Research

    Birmingham, Alabama, 35209, United States

  • Centre Hospitalier Universitaire de Lyon - Hopital Edouard Herriot

    Lyon Cédex 3, 69437, France

  • Charite Universitaetsmedizin Berlin, Charité Campus Virchow-Klinikum

    Berlin, 13353, Germany

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717, Japan

  • Chris OBrien Lifehouse

    Camperdown, New South Wales, 2050, Australia

  • City of Hope National Medical Center

    Duarte, California, 91010, United States

  • Complexo Hospitalario Universitario de Ourense

    Ourense, Galicia, 32005, Spain

  • Evgenidio Hospital I Agia Trias

    Athens, 11528, Greece

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, 20133, Italy

  • Fondazione Policlinico Tor Vergata

    Roma (RM), 00133, Italy

  • General Hospital of Athens Laiko

    Athens, 11527, Greece

  • GenesisCare -North Shore (Oncology)

    St Leonards, New South Wales, 2065, Australia

  • Health Pharma Professional Research SA de CV

    Mexico City, Mexico City, 03100, Mexico

  • Hokkaido University Hospital

    Sapporo, Hokkaido, 060-8648, Japan

  • Hospital General Universitario de Elche

    Elche, Valencia, 03203, Spain

  • Hospital General Universitario de Valencia

    Valencia, Valencia, 46014, Spain

  • Hospital Universitari Vall d Hebron

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Marques de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004, Spain

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18014, Spain

  • Hospital Universitario de Navarra

    Pamplona, Navarre, 31008, Spain

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalonia, 08041, Spain

  • Hygeia Hospital

    Athens, 15123, Greece

  • Hyogo Cancer Center

    Akashi-shi, Hyōgo, 673-8558, Japan

  • Hôpital Européen Georges Pompidou

    Paris, 75015, France

  • Hôpital Haut -lévêque

    Pessac, 33604, France

  • Institut regional du Cancer Montpellier

    Montpellier, 34298, France

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione Giovanni Pascale

    Naples, 80131, Italy

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128, Italy

  • Istituto Ospedaliero Fondazione Poliambulanza

    Brescia, 25124, Italy

  • Johns Hopkins University School of Medicine

    Washington D.C., District of Columbia, 20016, United States

  • Kanagawa Prefectural Hospital Organization Kanagawa Cancer Center

    Yokohama, Kanagawa, 241-8515, Japan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756, Taiwan

  • Kelsey Research Foundation

    Houston, Texas, 77025, United States

  • Klinikum der Universitaet Muenchen Campus Grosshadern

    München, 81377, Germany

  • Lakes Research LLC

    Miami Lakes, Florida, 33014, United States

  • Lancaster General Hospital Ann B Barshinger Cancer Institute

    Lancaster, Pennsylvania, 17601, United States

  • Linkou Chang Gung Memorial Hospital of Chang Gung Medical Foundation

    Taoyuan, 33305, Taiwan

  • Lumi Research

    Kingwood, Texas, 77339, United States

  • Maidstone Hospital

    Maidstone, ME16 9QQ, United Kingdom

  • Moses H Cone Memorial Hospital

    Greensboro, North Carolina, 27403, United States

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN, United Kingdom

  • National Cancer Center Hospital

    Chuo-ku, Tokyo, 104-0045, Japan

  • National Cancer Center Hospital East

    Kashiwa-shi, Chiba, 277-8577, Japan

  • National Cheng Kung University Hospital

    Tainan, 70403, Taiwan

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, Fukuoka, 811-1395, Japan

  • National Hospital Organization Osaka National Hospital

    Osaka, Osaka, 540-0006, Japan

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280, Japan

  • National Taiwan University Hospital

    Taipei, 10002, Taiwan

  • Northwest Georgia Oncology Centers PC

    Marietta, Georgia, 30060, United States

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871, Japan

  • Ospedale Policlinico San Martino IRCCS

    Genova, 16132, Italy

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168, Italy

  • Revive Research Institute

    Farmington Hills, Michigan, 48334, United States

  • Revive Research Institute

    Sterling Heights, Michigan, 48314, United States

  • Royal Free Hospital

    London, NW3 2QG, United Kingdom

  • Royal Marsden Hospital

    London, SW3 6JJ, United Kingdom

  • Royal Marsden Hospital

    Sutton, SM2 5PT, United Kingdom

  • Saitama Cancer Center

    Kitaadachi-gun, Saitama, 362-0806, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203, United States

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Severance Hospital Yonsei University Health System

    Seoul, 03722, South Korea

  • Shizuoka Cancer Center

    Sunto-gun, Shizuoka, 411-8777, Japan

  • Sparrow Clinical Research Institute

    Lansing, Michigan, 48912, United States

  • St Marianna University Hospital

    Kawasaki-shi, Kanagawa, 216-8511, Japan

  • Superare Centro de Infusion SA de CV

    Mexico City, Mexico City, 06760, Mexico

  • Taipei Veterans General Hospital

    Taipei, 11217, Taiwan

  • The Cancer Institute Hospital of Japanese Foundation for Cancer Research

    Koto-ku, Tokyo, 135-8550, Japan

  • The Mark H Zangmeister Center

    Columbus, Ohio, 43210, United States

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011, Australia

  • Theagenion Anticancer Hospital

    Thessaloniki, 54007, Greece

  • Trials In Medicine SC

    Mexico City, 06700, Mexico

  • Universitaetsklinikum Carl Gustav Carus an der Technischen Universitaet Dresden

    Dresden, 01307, Germany

  • Universitaetsklinikum der Eberhard Karls Universitaet Tuebingen

    Tübingen, 72076, Germany

  • Universitaetsmedizin Goettingen - Georg-August-Universitaet

    Göttingen, 37075, Germany

  • University Hospital of Heraklion

    Heraklion - Crete, 71500, Greece

  • University Hospital of Patras

    Pátrai, 26504, Greece

  • University of California Irvine

    Orange, California, 92868, United States

  • University of Michigan

    Ann Arbor, Michigan, 48106-0995, United States

  • Upstate University Hospital

    Syracuse, New York, 13210, United States

  • Westmead Hospital

    Westmead, New South Wales, 2145, Australia

  • White Plains Hospital Center for Cancer Care

    White Plains, New York, 10601, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.