Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)

Description

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * How many people have the cancer respond (get smaller or go away) to treatment

Conditions

Gastrointestinal Cancer

Study Overview

Study Details

Study overview

Researchers want to learn if patritumab deruxtecan (MK-1022) can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are advanced (the cancer has spread to other parts of the body). The goals of this study are to learn: * About the safety and how well people tolerate of patritumab deruxtecan * 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 Patritumab Deruxtecan in Gastrointestinal Cancers

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)

Condition
Gastrointestinal Cancer
Intervention / Treatment

-

Contacts and Locations

Miami Beach

Mount Sinai Medical Center Comprehensive Cancer Center ( Site 1213), Miami Beach, Florida, United States, 33140

Marietta

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1203), Marietta, Georgia, United States, 30060

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 and/or unresectable biliary tract cancer (BTC)
  • * Hepatocellular carcinoma (HCC) not amenable to locoregional therapy
  • * Has received prior therapy for the cancer
  • * Has recovered from any side effects due to previous cancer treatment
  • * Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at Screening.
  • * Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses
  • * Has clinically significant corneal disease
  • * Has uncontrolled, significant cardiovascular disease or cerebrovascular 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

2028-07-24