Study

Overview

Official Title: 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

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy 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 and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy • How many people have the cancer respond (get smaller or go away) to treatment

Study Type:

Interventional

Study Phase:

Phase 1/Phase 2

Estimated Enrollment:

130

Study Start Date:

June 2024

Estimated Study Completion Date:

December 2028

Estimated Primary Completion Date:

December 2028

Eligibility

Ages Eligible for Study:

18 years and older

Genders Eligible for Study:

All

Accepts Healthy Volunteers:

No

CRITERIA

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has one of the following cancers:
- Unresectable or metastatic colorectal cancer
- Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
- Advanced and/or unresectable biliary tract cancer (BTC)
Has received prior therapy for the cancer
Has recovered from any side effects due to previous cancer treatment

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

History of severe eye disease
Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease

Locations

United States Toll Free Number 1-800-770-4674

Gainesville, Florida, 32610
Miami Beach, Florida, 33140
Marietta, Georgia, 30060
New York, New York, 10016
Roanoke, Virginia, 24014
Madison, Wisconsin, 53792

Canada Study Coordinator 5148908000

Results

No Study Results Posted

Plain Language Summaries

Protocols

Protocol Plain Language Summary - MK-9999-02A-01

Study Detail

A clinical study of MK-2870 alone or with chemotherapy to treat gastrointestinal cancers (MK-9999-02A)