Study on Using AMG 510 (Sotorasib) and Panitumumab for Treating KRAS G12C Mutant Solid Tumor Cancers

Sponsor: National Cancer Institute (NCI)

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05638295

Provider View

This clinical trial is testing a new treatment using AMG 510 (sotorasib) with or without panitumumab to see how well it works in patients with advanced solid tumors that have a specific KRAS G12C mutation. The study aims to find out if this combination can help stop or slow down the growth of cancer cells.

Patient Parameters

Program Overview

This study is exploring a treatment for patients with advanced solid tumors that have a specific mutation called KRAS G12C. The treatment involves using a drug called AMG 510 (sotorasib), which blocks a protein that helps cancer cells grow, and may be combined with another drug called panitumumab, which also helps stop cancer cell growth. The goal is to see if this combination can effectively reduce or control the cancer in patients whose tumors have spread to other parts of the body.

Description

The study is divided into two groups based on previous treatments:

  • Cohort I: Patients who have not received a KRAS G12C inhibitor before are randomly assigned to one of two treatment arms:

    • Arm A: Patients take AMG 510 (sotorasib) daily and receive panitumumab through an IV on specific days. This cycle repeats every 28 days unless the cancer progresses or side effects become too severe.
    • Arm B: Patients take AMG 510 (sotorasib) daily. If the cancer progresses, they may switch to Cohort II for combination treatment.

  • Cohort II: Patients who have previously been treated with a KRAS G12C inhibitor and whose cancer has progressed are assigned to:

    • Arm C: Patients receive the combination treatment of AMG 510 (sotorasib) and panitumumab as in Arm A.

After completing the study treatment, patients will have follow-up visits to monitor their health and the treatment's effects.

The study also involves collecting blood samples, biopsies, and imaging scans to evaluate the treatment's impact on the cancer.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed KRAS G12C mutation in their cancer.
  • Must have advanced solid tumors that can be safely biopsied.
  • Must have previously tried standard treatments for their cancer.
  • Must have a good performance status, meaning they are able to carry out daily activities with minimal restrictions.
  • Must not have any serious infections or lung diseases.
  • Must not be pregnant or breastfeeding and must agree to use effective contraception during the study.
  • Must have adequate organ function as shown by specific blood tests.
  • Must not have colorectal cancer or non-small cell lung cancer for Cohort I.
  • Must not have been treated with a KRAS G12C inhibitor before for Cohort I.
  • Must have progressed after treatment with a KRAS G12C inhibitor for Cohort II.
  • Must not have been treated with a KRAS G12C inhibitor combined with an EGFR inhibitor for Cohort II.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.