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RecruitingInterventionalPhase 3

Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)

NCT ID: NCT06252649Sponsor: AmgenLast updated: 2026-06-10

Summary

The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.

Arms & interventions

  • DrugFOLFIRI Regimen

    Combination of irinotecan, leucovorin, and 5-fluorouracil given via IV infusion Q2W.

  • DrugSotorasib

    Immediate-release solid dosage form administered orally.

  • DrugPanitumumab

    Administered via IV infusion Q2W.

  • DrugBevacizumab-awwb

    Administered via IV infusion Q2W.

Outcome measures

Primary

  • PFS per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Time frame: Up to Approximately 3 Years

Secondary

  • Overall Survival (OS)

    Time frame: Up to Approximately 5 Years

  • Objective Response Rate (ORR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Objective Response (OR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Duration of Response (DOR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Disease Control Rate (DCR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Time to Response (TTR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Depth of Response per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Time to Early Tumor Shrinkage (ETS) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • PFS Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • ORR Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • DOR Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • DCR Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • TTR Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Depth of Response Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Time to ETS Based on Investigator's Assessment per RECIST v1.1

    Time frame: Up to Approximately 5 Years

  • Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to Approximately 5 Years

  • Pre-dose (Ctrough) Concentrations of Sotorasib

    Time frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

  • Maximum Plasma Concentration (Cmax) of Sotorasib

    Time frame: Day 1 (pre-dose) to week 4 (post dose) on cycle 2 (one cycle = 28 days)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Inclusion Criteria: * Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay. * Central laboratory detection 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

Study locations (26)

Ironwood Cancer and Research Centers Scottsdale

Chandler, Arizona, 85224

Recruiting

Providence Saint Jude Medical Center

Fullerton, California, 92835

Completed

City of Hope National Medical Center

Long Beach, California, 90813

Recruiting

Cancer and Blood Research Center, LLC

Los Alamitos, California, 90720

Recruiting

California Research Institute

Los Angeles, California, 90027

Recruiting

Norwalk Hospital

Norwalk, Connecticut, 06856

Terminated

Cancer Specialists of North Florida - Southpoint

Jacksonville, Florida, 32256

Recruiting

D and H Cancer Research Center

Margate, Florida, 33063

Terminated

Mid Florida Hematology and Oncology Centers PA

Orange City, Florida, 32763

Terminated

Boca Raton Clinical Research Medical Center Inc

Plantation, Florida, 33322

Terminated

Georgia Cancer Specialists

Atlanta, Georgia, 30342

Terminated

Insight Research Institute

Chicago, Illinois, 60616

Recruiting

Hope and Healing Cancer Services

Hinsdale, Illinois, 60521

Terminated

Orchard Healthcare Research Inc

Skokie, Illinois, 60076

Terminated

Pikeville Medical Center

Pikeville, Kentucky, 41501

Recruiting

Henry Ford Health System

Detroit, Michigan, 48202

Recruiting

Cancer and Hematology Centers of Western Michigan

Grand Rapids, Michigan, 49503

Recruiting

Saint Louis Cancer Care West County

Bridgeton, Missouri, 63044

Completed

Minniti Center for Medical Oncology and Hematology

Mickleton, New Jersey, 08056

Terminated

Duke Cancer Center

Durham, North Carolina, 27710

Recruiting

FirstHealth Cancer Center

Pinehurst, North Carolina, 28374

Recruiting

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Recruiting

Carolina Blood and Cancer Care

Rock Hill, South Carolina, 29732

Terminated

Tennessee Oncology PLLC - Chattanooga

Nashville, Tennessee, 37203

Recruiting

Tennessee Oncology, PLLC

Nashville, Tennessee, 37203

Recruiting

Vanderbilt University Medical Center

Nashville, Tennessee, 37232

Recruiting

References

  • Deming DA. Development of KRAS Inhibitors and Their Role for Metastatic Colorectal Cancer. J Natl Compr Canc Netw. 2025 Jan 3;23(1):e247067. doi: 10.6004/jnccn.2024.7067.(PubMed)
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 | Cancerify