Actively Recruiting
Phase 1 Study to Assess Safety and Tolerability of MK-8294 Given by IV Infusion in Adults with Advanced Solid Tumors
Led by Merck Sharp & Dohme LLC · Updated on 2026-07-17
67
Participants Needed
6
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying MK-8294, a targeted therapy designed to treat advanced solid tumors, including various squamous cell carcinomas and breast, endometrial, and bladder cancers. This phase 1 open-label study aims to evaluate the safety of MK-8294, determine if patients can tolerate it, and identify the highest dose level that participants can handle. The study enrolls adults with confirmed advanced or metastatic solid tumors who have limited or no standard treatment options. Participants will receive MK-8294 as a monotherapy in escalating intravenous doses starting from 30 micrograms up to 70 milligrams, given on Days 1, 8, and 15 of each 21-day cycle. There is no maximum number of treatment cycles, and participants will continue treatment until criteria for stopping are met. Some participants may also undergo optional PET imaging using a CD8 tracer to help assess treatment effects. Throughout the study, participants will be carefully monitored for side effects and treatment tolerance, with dose-limiting toxicities tracked up to about 35 days. Researchers will also observe adverse events and reasons for discontinuing treatment for up to approximately two years. Blood samples will be collected during each cycle to measure MK-8294 levels and immune responses. The overall study duration may last up to two years to fully assess safety and treatment effects.
CONDITIONS
Brief Title
A Clinical Study of MK-8294 in Participants With Advanced Solid Tumors (MK-8294-001)
Research Team
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