NCT06242691

Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)

A Phase 1/2 Open-label Study to Evaluate the Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses

Conditions

• Advanced Solid Tumors

Interventions

Type	Name	Description
BIOLOGICAL	MK-1200	IV Infusion
DRUG	Antiemetic	One or more prophylactic antiemetic(s) (e.g. 5-HT3 receptor antagonists, dexamethasone, neurokinin-1 receptor antagonists, etc.) may be selected based on previous response of participants to antiemetic medications and individual factors, and will be administered per approved product label prior to MK-1200 infusion

Timeline

• Start date: 2024-02-28
• Primary completion: 2025-06-17
• Completion: 2025-06-17
• First posted: 2024-02-05
• Last updated: 2026-03-06

Locations

16 sites across 6 countries: United States, Australia, Chile, China, Israel, South Korea

Regulatory

• FDA-regulated drug study