Calderasib (MK-1084) with or without cetuximab for advanced KRAS G12C solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2, multicenter interventional study enrolling people with locally advanced or metastatic non-colorectal solid tumors that harbor the KRAS G12C mutation. Participants receive calderasib alone or calderasib plus cetuximab and are followed for tumor response and safety. The main goals are to compare how often tumors shrink or disappear with each approach and to document tolerability and adverse effects. Study visits and treatments occur at participating U.S. cancer centers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

* Has locally advanced unresectable or metastatic solid tumor malignancy other than colorectal cancer and has progressed on, or following, standard of care systemic treatment
* Has a tumor that demonstrates the presence of Kirsten rat sarcoma (KRAS) G12C mutation

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

* Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
* Has known additional malignancy that is progressing or has required active treatment within the past 3 years
* Has known active central nervous system metastases and/or carcinomatous meningitis and/or primary brain tumors
* Has active infection, other than those permitted per protocol, requiring systemic therapy
* Has not adequately recovered from major surgery or has ongoing surgical complications

Where it's running

• Greater Baltimore Medical Center ( Site 1104)
  Baltimore, Maryland, United States Recruiting
• START Midwest ( Site 1103)
  Grand Rapids, Michigan, United States Recruiting
• Comprehensive Cancer Centers of Nevada ( Site 1109)
  Las Vegas, Nevada, United States Recruiting
• Rutgers Cancer Institute of New Jersey ( Site 1100)
  New Brunswick, New Jersey, United States Recruiting
• START Mountain Region ( Site 1106)
  West Valley City, Utah, United States Recruiting
• Virginia Cancer Specialists ( Site 1102)
  Fairfax, Virginia, United States Recruiting

+22 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Toll Free Number
• Email: Trialsites@msd.com
• Phone: 1-888-577-8839

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.