Title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers

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

Objective
Primary Objectives:

1) To evaluate the safety and tolerability of patritumab deruxtecan (HER3-DXd)

2) To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR (Cohort 1, Cohort 2, and participants who received the preliminary RP2D in Cohort 3)

Treatment Biological: Patritumab deruxtecan

Key Eligibility 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 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

Applicable Disease Sites
Colon and Rectum; Gastrointestinal cancers, other; Liver

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital