A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001) (NCT07247110) | Clinical Trial Compass
RecruitingPhase 1
A Clinical Study of MK-4716 in People With Certain Solid Tumors (MK-4716-001)
United States, Australia250 participantsStarted 2025-12-16
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 immunodef…
What they're measuring
1
Number of Participants Who Experience One or More Dose-Limiting Toxicities (DLT)
Timeframe: Up to approximately 28 days
2
Number of Participants Who Experience an Adverse Event (AE)
Timeframe: Up to approximately 5 years
3
Number of Participants Who Discontinue Study Intervention Due to an AE