NCT06596694 Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
| NCT ID | NCT06596694 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Merck Sharp & Dohme LLC |
| Condition | Gastrointestinal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-11-03 |
| Primary Completion | 2028-12-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 180 participants in total. It began in 2024-11-03 with a primary completion date of 2028-12-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
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 * 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
Contact & Investigator
Medical Director
STUDY DIRECTOR
Merck Sharp & Dohme LLC
Frequently Asked Questions
Who can join the NCT06596694 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastrointestinal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06596694 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06596694 currently recruiting?
Yes, NCT06596694 is actively recruiting participants. Contact the research team at Trialsites@msd.com for enrollment information.
Where is the NCT06596694 trial being conducted?
This trial is being conducted at Santa Monica, United States, Aurora, United States, Washington D.C., United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06596694 clinical trial?
NCT06596694 is sponsored by Merck Sharp & Dohme LLC. The principal investigator is Medical Director at Merck Sharp & Dohme LLC. The trial plans to enroll 180 participants.
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