NCT07209111 A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
| NCT ID | NCT07209111 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Neoplasm Malignant |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-12-04 |
| Primary Completion | 2032-04-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 150 participants in total. It began in 2025-12-04 with a primary completion date of 2032-04-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT07209111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neoplasm Malignant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07209111 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07209111 currently recruiting?
Yes, NCT07209111 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT07209111 trial being conducted?
This trial is being conducted at Baltimore, United States, Grand Rapids, United States, Las Vegas, United States, New Brunswick, United States and 11 additional locations.
Who is sponsoring the NCT07209111 clinical trial?
NCT07209111 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 150 participants.