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Recruiting Phase 1

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

NCT07247110 · tracked via the Priya Life Science USA tracker
Phase
Phase 1
Started
2025-12-16
Last updated
2026-10-30

Condition(s) studied

Malignant Neoplasm

Investigational drug(s) / intervention(s)

MK-4716Pembrolizumab →Cetuximab →

MK-4716: Oral administration

Pembrolizumab: Intravenous administration

Cetuximab: Intravenous administration

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT) — Up to approximately 28 days
    A DLT is defined as the occurrence of protocol-specified toxicities, unless clearly related to disease progression or intercurrent illness.
  • Number of Participants Who Experience an Adverse Event (AE) — Up to approximately 4 years
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.
  • Number of Participants Who Discontinue Study Intervention Due to an AE — Up to approximately 4 years
    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention.

Trial sites (21)

FacilityCityRegionStatus
Rutgers Cancer Institute of New Jersey ( Site 0052) New Brunswick New Jersey Recruiting
NEXT Oncology ( Site 0051) Irving Texas Recruiting
NEXT Virginia ( Site 0054) Fairfax Virginia Recruiting
Blacktown Hospital ( Site 0455) Sydney New South Wales Recruiting
Monash Health ( Site 0452) Clayton Victoria Recruiting
The Alfred Hospital ( Site 0453) Melbourne Victoria Recruiting
One Clinical Research ( Site 0454) Nedlands Western Australia Recruiting
Princess Margaret Cancer Centre ( Site 0001) Toronto Ontario Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 0003) Montreal Quebec Recruiting
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0002) Québec Quebec Recruiting
FALP-UIDO ( Site 0101) Santiago Region M. de Santiago Recruiting
Pontificia Universidad Catolica de Chile-CICUC ( Site 0103) Santiago Region M. de Santiago Recruiting
Bradfordhill ( Site 0102) Santiago Region M. de Santiago Recruiting
Rambam Health Care Campus ( Site 0252) Haifa Israel Recruiting
Rabin Medical Center ( Site 0253) Petah Tikva Israel Recruiting
Sheba Medical Center ( Site 0251) Ramat Gan Israel Recruiting
Seoul National University Hospital ( Site 0501) Seoul South Korea Recruiting
Asan Medical Center ( Site 0502) Seoul South Korea Recruiting
Hospital General Universitari Vall d Hebron ( Site 0360) Barcelona Spain Recruiting
Hospital Clinic de Barcelona ( Site 0362) Barcelona Spain Recruiting
Hospital Universitario Fundacion Jimenez Diaz ( Site 0361) Madrid Spain Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07247110 on ClinicalTrials.gov ↗ ← All trials in the USA