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

Description

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

Conditions

Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Gainesville

University of Florida College of Medicine ( Site 0281), Gainesville, Florida, United States, 32610

Miami Beach

Mount Sinai Cancer Center ( Site 0287), Miami Beach, Florida, United States, 33140

Marietta

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303), Marietta, Georgia, United States, 30060

New York

Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324), New York, New York, United States, 10016

Roanoke

Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295), Roanoke, Virginia, United States, 24014

Madison

University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293), Madison, Wisconsin, United States, 53792

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Merck Sharp & Dohme LLC,

Medical Director, STUDY_DIRECTOR, Merck Sharp & Dohme LLC

Study Record Dates

2028-12-03