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Trial Title:
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)
NCT ID:
NCT06596694
Condition:
Gastrointestinal Cancer
Conditions: Official terms:
Gastrointestinal Neoplasms
Patritumab deruxtecan
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
Patritumab deruxtecan
Description:
Administered via intravenous (IV) infusion
Arm group label:
Patritumab deruxtecan
Other name:
MK-1022
Other name:
HER3-DXd
Other name:
U3-1402
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
Criteria for 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, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at Screening.
- Has clinically severe respiratory compromise (based on the investigator's
assessment) resulting from intercurrent pulmonary illnesses
- Has clinically significant corneal disease
- Has uncontrolled, significant cardiovascular disease or cerebrovascular disease
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Rambam Health Care Campus ( Site 0603)
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97247776700
Facility:
Name:
Sourasky Medical Center ( Site 0601)
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Contact:
Last name:
Study Coordinator
Phone:
97236973082
Start date:
October 30, 2024
Completion date:
July 24, 2028
Lead sponsor:
Agency:
Merck Sharp & Dohme LLC
Agency class:
Industry
Collaborator:
Agency:
Daiichi Sankyo
Agency class:
Industry
Source:
Merck Sharp & Dohme LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06596694
https://www.merckclinicaltrials.com/
