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A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)

NCT07209111

RecruitingPhase 2

Sponsor: Merck Sharp & Dohme LLC

Conditions: Neoplasm Malignant

Interventions: Calderasib, Cetuximab

Countries: United States, Australia, Canada, Chile, China, Denmark, Germany, Greece

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (64)

Baltimore, Maryland, United States
Grand Rapids, Michigan, United States
Las Vegas, Nevada, United States
New Brunswick, New Jersey, United States
West Valley City, Utah, United States
Fairfax, Virginia, United States
Randwick, New South Wales, Australia
Westmead, New South Wales, Australia
Melbourne, Victoria, Australia
Montreal, Quebec, Canada
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Santiago, Region M. de Santiago, Chile
Beijing, Beijing Municipality, China
Xiamen, Fujian, China
Guangzhou, Guangdong, China
Guangzhou, Guangdong, China
Harbin, Heilongjiang, China
Wuhan, Hubei, China
Nanjing, Jiangsu, China
Nanchang, Jiangxi, China
Jinan, Shandong, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Shanghai, Shanghai Municipality, China
Hangzhou, Zhejiang, China
Linhai, Zhejiang, China
Copenhagen, Capital Region, Denmark
Odense, Region Syddanmark, Denmark
+ 34 more on CT.gov