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 — DRUG
    Oral administration
  • Pembrolizumab — BIOLOGICAL
    Intravenous administration
  • Cetuximab — BIOLOGICAL
    Intravenous 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 Escalation
    Participants receive MK-4716 at varying dose levels and schedules.
  • Experimental: MK-4716 + Pembrolizumab
    Participants will receive MK-4716 + Pembrolizumab
  • Experimental: MK-4716 + Cetuximab
    Participants 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

Locations (3)

FacilityCityStateZIPSite coordinators
Rutgers Cancer Institute of New Jersey ( Site 0052)New BrunswickNew Jersey08903
Study Coordinator
732-253-3939
NEXT Oncology ( Site 0051)IrvingTexas75039
Study Coordinator
972-893-8800
NEXT Virginia ( Site 0054)FairfaxVirginia22031
Study Coordinator
703-783-4510

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