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

Launched by MERCK SHARP & DOHME LLC · Sep 11, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called patritumab deruxtecan for people with advanced gastrointestinal (GI) cancers. Specifically, it focuses on cancers that have spread to other parts of the body, including colorectal cancer, biliary tract cancer, and liver cancer. The researchers want to find out how safe this treatment is and how well it works in making the cancer shrink or go away.

To participate in this trial, you need to be between the ages of 65 and 74 and have one of the specified cancers that cannot be surgically removed. It's important that you have already received some form of treatment for your cancer and have fully recovered from any side effects from that treatment. If you have certain lung or heart conditions, or specific eye diseases, you may not be eligible to join the study. Participants can expect to be closely monitored during the trial to ensure their safety and to check how well the treatment is working.

Gender

ALL

Eligibility 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 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