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Recruiting Phase 2 NCT07209111

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

Phase 2 – studying effectiveness and dosage
Conditions: Neoplasm Malignant

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
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 14
Australia (1)
Prince of Wales Hospital-Medical Oncology ( Site 1003)
Randwick , New South Wales
Study Coordinator
China (1)
Beijing Cancer hospital ( Site 1318)
Beijing , Beijing Municipality
Study Coordinator
Denmark (1)
Rigshospitalet ( Site 1403)
Copenhagen , Capital Region
Study Coordinator
Greece (1)
European Interbalkan Medical Center-Oncology Department ( Site 1700)
Thessaloniki
Study Coordinator
Israel (1)
Emek Medical Center ( Site 1800)
Afula
Study Coordinator
Italy (1)
Istituto Clinico Humanitas-U.O di Oncologia medica ed Ematologia ( Site 1902)
Rozzano , Milano
Study Coordinator
Norway (1)
Haukeland universitetssykehus ( Site 2102)
Bergen , Hordaland
Study Coordinator
Poland (1)
MTZ Clinical Research powered by Pratia ( Site 2205)
Warsaw , Masovian Voivodeship
Study Coordinator
South Korea (1)
Seoul National University Hospital ( Site 2301)
Seoul
Study Coordinator
Spain (1)
Hospital Virgen de la Victoria ( Site 2403)
Málaga , Malaga
Study Coordinator
Sweden (1)
Karolinska Universitetssjukhuset Solna ( Site 2501)
Stockholm , Stockholm County
Study Coordinator
Turkey (1)
Hacettepe Universitesi-oncology hospital ( Site 2700)
Ankara
Study Coordinator
United Kingdom (1)
The Christie NHS Foundation Trust ( Site 2803)
Manchester
Study Coordinator
United States (1)
Greater Baltimore Medical Center ( Site 1104)
Baltimore , Maryland
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.12.2025
Completion date
09.04.2032
Registry ID
NCT07209111
Source
anzctr
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