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Recruiting Phase 2 NCT05638295

Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)

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Trial Parameters

Condition Advanced Malignant Solid Neoplasm
Sponsor National Cancer Institute (NCI)
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 105
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-01
Completion 2028-12-31
Interventions
Biopsy ProcedureBiospecimen CollectionComputed Tomography

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Brief Summary

This phase II ComboMATCH treatment trial tests how well AMG 510 (sotorasib) with or without panitumumab works in treating patients with KRAS G12C mutant solid tumors that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Sotorasib is in a class of medications called KRAS inhibitors. It works by blocking the action of the abnormal protein that signals cancer cells to multiply. This helps stop or slow the spread of cancer cells. Panitumumab is in a class of medications called monoclonal antibodies. It works by slowing or stopping the growth of cancer cells. Giving combination panitumumab and sotorasib may kill more tumor cells in patients with advanced solid tumors with KRAS G12C mutation.

Eligibility Criteria

Inclusion Criteria: * Patient must have enrolled onto EAY191 and must have been given a treatment assignment to ComboMATCH to EAY191-E5 based on the presence of an actionable mutation as defined in EAY191 * Patient must be enrolled on the ComboMATCH Registration Protocol (EAY191) at the time of registration/randomization to the EAY191-E5 study * Patient must be \>= 18 years of age * Patient must have a KRAS G12C alteration as determined by the ComboMATCH screening assessment * Patient must have disease that can be safely biopsied and agree to a pre-treatment biopsy or have tissue available from within 12 months prior to the date of registration on the ComboMATCH Registration Trial (EAY191-E5) * NOTE: The current actionable marker of interest (aMOI)/actionable alteration list for this treatment trial can be found on the Cancer Trials Support Unit (CTSU) website: www.ctsu.org (final URL pending) * NOTE: Novel/Dynamic aMOI can be submitted for review per the process described in the Combo

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