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Recruiting Phase 1 NCT07247110

A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)

Phase 1 – testing safety in a small group of people
Conditions: Malignant Neoplasm

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has a confirmed diagnosis of locally advanced unresectable or metastatic solid tumor * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Must demonstrate presence of Kirsten rat sarcoma viral oncogene homolog (KRAS) alteration * Subset of arm MK-4716 Dose Escalation and subset of arm MK-4716 + Cetuximab: Has received at least 1 prior line of systemic therapy for locally advanced unresectable or metastatic disease * Arm MK-4716 + Pembrolizumab: Has a confirmed diagnosis of metastatic non-small cell lung cancer * Arm MK-4716 + Pembrolizumab: Must demonstrate presence of KRAS alteration * Arm MK-4716 + Pembrolizumab: Must be untreated * Has measurable disease * Has the ability to swallow and retain oral medication Exclusion Criteria: * Arm MK-4716 + Pembrolizumab: Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Arm MK-4716 + Pembrolizumab: Has received any prior immunotherapy and was discontinued from that treatment * Arm MK-4716 + Pembrolizumab: Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * History of human immunodeficiency virus infection * Has a known additional malignancy that is progressing or has required active treatment within the past 2 years * Has a known active central nervous system metastases and/or carcinomatous meningitis * History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has Hepatitis B or Hepatitis C virus infection * History of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications
Locations 6
Australia (1)
Blacktown Hospital ( Site 0455)
Sydney , New South Wales
Study Coordinator
Chile (1)
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103)
Santiago , Region M. de Santiago
Study Coordinator
Israel (1)
Rambam Health Care Campus ( Site 0252)
Haifa
Study Coordinator
South Korea (1)
Seoul National University Hospital ( Site 0501)
Seoul
Study Coordinator
Spain (1)
Hospital General Universitari Vall d Hebron ( Site 0360)
Barcelona
Study Coordinator
United States (1)
Rutgers Cancer Institute of New Jersey ( Site 0052)
New Brunswick , New Jersey
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
16.12.2025
Completion date
01.12.2030
Registry ID
NCT07247110
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.