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Recruiting
NCT07209111
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Conditions: Neoplasm Malignant
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE2
Enrollment: 150
Sponsor: Merck Sharp & Dohme LLC
Location: Greater Baltimore Medical Center ( Site 1104) Baltimore Maryland
Summary
Researchers want to learn if calderasib given alone or with cetuximab can treat certain advanced solid tumors in people with the KRAS G12C mutation.
The goals of this study are to learn:
* How many people have the cancer respond (get smaller or go away) to calderasib alone or with cetuximab and how these responses compare
* About the safety of calderasib alone or with cetuximab and if people tolerate the treatments.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07209111). StuddyBuddy aggregates publicly available trial information.