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

NCT06428409 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2026-01-22

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Merck Sharp & Dohme LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-20
Primary Completion
2029-10-16
Completion
2029-10-16
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • Chile
  • China
  • Italy
  • Japan
  • South Korea
  • Spain
  • Switzerland
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06428409 on ClinicalTrials.gov