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NCT Number: 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

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.

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Key information

Conditions

Metastatic Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Universitario Fundacion Favaloro, CABA, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FOLFIRI regimen

Drug

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

Sotorasib

Drug

Immediate-release solid dosage form administered orally.

Other names: AMG 510, Lumakras, Lumykras

Panitumumab

Drug

Administered via IV infusion Q2W.

Other names: Vectibix

Bevacizumab-Awwb

Drug

Administered via IV infusion Q2W.

Other names: MVASI

Primary outcomes

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

    Time frame: Up to Approximately 3 Years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

  3. Objective Response (OR) per RECIST v1.1

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

  7. Depth of Response per RECIST v1.1

    Time frame: Up to Approximately 5 Years

    Depth of response is measured as the percentage of tumor shrinkage calculated as the best percentage change from baseline in lesion sum diameters.

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

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

    Time frame: Up to Approximately 5 Years

  16. Number of Participants Experiencing Adverse Events (AEs)

    Time frame: Up to Approximately 5 Years

    An AE is defined as any untoward medical occurrence in participant or clinical investigation subject administered a pharmaceutical product, which does not necessarily have to have a causal relationship with this treatment. A serious AE is defined as any AE that results in death, is life threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect or important medical events that do not meet the preceding criteria but based on appropriate medical judgment may jeopardize the patient or may require medical or surgical intervention to prevent any of the outcomes listed above.

  17. Pre-dose (Ctrough) Concentrations of Sotorasib

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

  18. Maximum Plasma Concentration (Cmax) of Sotorasib

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

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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)

Acronym: CodeBreaK 301

Important dates

Study start
2024
Primary completion
2028
Study completion
2032
First posted
Feb 12, 2024
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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