Phase 1 Study of MK-4716 Alone or With Pembrolizumab or Cetuximab in Adults With KRAS-Altered Advanced or Metastatic Solid Tumors

What this Trial Is About

Researchers are evaluating the safety and tolerability of MK-4716, a drug being studied alone or combined with other treatments in people with certain advanced or metastatic solid tumors that have KRAS alterations. This phase 1, open-label study includes participants with locally advanced unresectable or metastatic solid tumors or metastatic non-small cell lung cancer, focusing on those with measurable disease and specific prior treatment histories. Participants receive MK-4716 at varying dose levels and schedules as monotherapy or combined with Pembrolizumab or Cetuximab. MK-4716 is given orally, while Pembrolizumab and Cetuximab are administered intravenously. The study uses a parallel design with several experimental arms to assess different combinations and dosing. During the study, participants are monitored for dose-limiting toxicities up to about 28 days and for adverse events up to approximately four years. Researchers measure drug concentrations in the blood at designated timepoints, pharmacokinetics, and overall safety. Participants undergo regular evaluations to assess side effects, treatment tolerability, and disease status throughout the study period, which lasts until study completion in December 2030.

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