A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014) (NCT07209111) | Clinical Trial Compass
RecruitingPhase 2
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
United States, Australia, Canada150 participantsStarted 2025-12-04
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective Response Rate (ORR)
Timeframe: Up to approximately 76 months
2
Number of Participants Who Experience One or More Adverse Events (AEs)
Timeframe: Up to approximately 76 months
3
Number of Participants Who Discontinue Study Treatment Due to an AE