Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTH… (NCT06596694) | Clinical Trial Compass
RecruitingPhase 1/2
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
United States, Australia, Canada180 participantsStarted 2024-11-03
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* Locally advanced unresectable or metastatic gastroesophageal cancer
* 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) or pneumonitis that required steroids, or has current ILD or pneumonitis, and/or suspected ILD or 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Timeframe: Up to 21 days
2
Number of Participants with One or More Adverse Events (AEs)
Timeframe: Up to approximately 44 months
3
Number of Participants who Discontinue Study Intervention Due to an AE