NCT06428409

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment

Conditions

• Colorectal Cancer
• Pancreatic Ductal Adenocarcinoma
• Biliary Tract Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Sacituzumab tirumotecan	Given by IV infusion.
DRUG	Fluorouracil (5-FU)	5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
DRUG	Leucovorin (LV) or levoleucovorin	LV or levoleucovorin is administered by IV infusion every 2 weeks.
DRUG	Rescue medication	Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[H1\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
DRUG	Supportive care measures	Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
DRUG	Cisplatin	Given by IV infusion.
BIOLOGICAL	Pembrolizumab	Given by IV infusion.

Timeline

• Start date: 2024-06-20
• Primary completion: 2029-10-16
• Completion: 2029-10-16
• First posted: 2024-05-24
• Last updated: 2026-01-22

Locations

55 sites across 13 countries: United States, Australia, Canada, Chile, China, Italy, Japan, South Korea, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study