Trials Today

Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)

Purpose

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

Condition

Gastrointestinal Cancer

Eligibility

Eligible Ages: Over 18 Years
Eligible Sex: All
Accepts Healthy Volunteers: No

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

Exclusion Criteria

The main exclusion criteria include but are not limited to the following: - Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening - Has clinically severe respiratory compromise (based on the investigator's assessment) resulting from intercurrent pulmonary illnesses - Has evidence of any leptomeningeal disease - Has clinically significant corneal disease - Has uncontrolled, significant cardiovascular disease or cerebrovascular disease - Has evidence of ongoing uncontrolled systemic bacterial, fungal, or viral infection

Study Design

Phase: Phase 1/Phase 2
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)