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NCT07209111 · ClinicalTrials.gov registry record · Phase 2
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
A Phase 2 study of Neoplasm Malignant, sponsored by Merck Sharp & Dohme.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 150
- Enrollment target
- 20
- Study locations
NCT07209111: Recruiting Phase 2 study of Neoplasm Malignant, sponsored by Merck Sharp & Dohme.
NCT07209111 is a Phase 2 study of Neoplasm Malignant that is actively recruiting participants, run by Merck Sharp & Dohme. The registered enrollment target is 150 participants, below the 270-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (44% lower). The trial reports 20 study locations across 17 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07209111, a Phase 2 study of Neoplasm Malignant, is actively recruiting participants, sponsored by Merck Sharp & Dohme.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 150 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria In Solid Tumors Version 1.1 (RECIST 1.1). The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Conditions Studied
Interventions
- BIOLOGICAL Cetuximab
- DRUG Calderasib
Study Locations (20)
Shanghai Municipality
- Shanghai Chest Hospital ( Site 1300) - Shanghai
- Fudan University Shanghai Cancer Center ( Site 1325) - Shanghai
- Zhongshan Hospital,Fudan University ( Site 1301) - Shanghai
Zhejiang
- Zhejiang Cancer Hospital ( Site 1311) - Hangzhou
- Taizhou Hospital of Zhejiang Province ( Site 1312) - Linhai
Maryland
- Greater Baltimore Medical Center ( Site 1104) - Baltimore
Michigan
- START Midwest ( Site 1103) - Grand Rapids
New Jersey
- Rutgers Cancer Institute of New Jersey ( Site 1100) - New Brunswick
Utah
- START Mountain Region ( Site 1106) - West Valley City
Virginia
- Virginia Cancer Specialists ( Site 1102) - Fairfax
New South Wales
- Prince of Wales Hospital-Medical Oncology ( Site 1003) - Randwick
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2025-12-04 |
| Est. Completion | 2032-04-09 |
| Phase | Phase 2 |
What NCT07209111 shows while recruiting
NCT07209111 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 270-participant average among 7 other Neoplasm Malignant trials with a reported enrollment target (44% lower).
The record links to 1 condition, with Neoplasm Malignant appearing as the primary indexed condition, and to 2 interventions - of which Cetuximab is the first listed.
NCT07209111 names 20 study sites across 17 states, led by Shanghai Municipality, Zhejiang, Maryland.
Frequently Asked Questions
What is clinical trial NCT07209111 about?
NCT07209111 is a clinical study titled "A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)". 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 ho...
What is the current status of trial NCT07209111?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 150 participants. The study started on 2025-12-04. Estimated completion is 2032-04-09.
What conditions does trial NCT07209111 study?
This clinical trial studies the following conditions: Neoplasm Malignant.
What interventions are being tested in trial NCT07209111?
The interventions under investigation include: Cetuximab (BIOLOGICAL), Calderasib (DRUG).
Who is sponsoring clinical trial NCT07209111?
This trial is sponsored by Merck Sharp & Dohme, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07209111 being conducted?
This trial has 20 study locations across Maryland, Michigan, New Jersey, Utah, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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