A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
Part of paid clinical trials in New Brunswick, New Jersey.
- Sponsor
- Merck Sharp & Dohme LLC
- Study ID
- NCT07247110
- Phase
- PHASE1
- Status
- Recruiting
Conditions
- Malignant Neoplasm
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- MK-4716 — DRUGOral administration
- Pembrolizumab — BIOLOGICALIntravenous administration
- Cetuximab — BIOLOGICALIntravenous administration
Study Details
Researchers are looking for new ways to treat certain advanced or metastatic solid tumors. The goal of this study is to learn about the safety of MK-4716 and if people tolerate it when taken alone or with other treatments.
Key Dates
- Start date
- Dec 16, 2025
- Status verified
- May 2026
- Primary completion
- Dec 1, 2030
- Completion
- Dec 1, 2030
Study Design
- Enrollment
- 250 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: MK-4716 Dose EscalationParticipants receive MK-4716 at varying dose levels and schedules.
- Experimental: MK-4716 + PembrolizumabParticipants will receive MK-4716 + Pembrolizumab
- Experimental: MK-4716 + CetuximabParticipants will receive MK-4716 + Cetuximab
Primary Outcome Measure
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) [ Time Frame: Up to approximately 28 days ]
Central Contacts
- Toll Free Number1-888-577-8839
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Rutgers Cancer Institute of New Jersey ( Site 0052) | New Brunswick | New Jersey | 08903 | Study Coordinator 732-253-3939 |
| NEXT Oncology ( Site 0051) | Irving | Texas | 75039 | Study Coordinator 972-893-8800 |
| NEXT Virginia ( Site 0054) | Fairfax | Virginia | 22031 | Study Coordinator 703-783-4510 |
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