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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06596694
Registration number
NCT06596694
Ethics application status
Date submitted
11/09/2024
Date registered
19/09/2024
Date last updated
14/07/2025
Titles & IDs
Public title
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011) (HERTHENA-PanTumor02)
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Scientific title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
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Secondary ID [1]
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MK-1022-011
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Secondary ID [2]
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1022-011
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer
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Condition category
Condition code
Cancer
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Other cancer types
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Patritumab deruxtecan
Experimental: Patritumab deruxtecan - Participants receive patritumab deruxtecan intravenous (IV) infusion on Day 1 of each 21-day cycle (every 3 weeks) until disease progression, intolerable toxicity, or investigator decision.
Treatment: Other: Patritumab deruxtecan
Administered via intravenous (IV) infusion
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
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Assessment method [1]
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DLT will be defined as any drug-related adverse event observed during the DLT evaluation period that results in a change to a given dose or a delay in initiating the next 21-day cycle. The number of participants in the dose-escalation phase who experience a DLT will be presented.
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Timepoint [1]
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Up to 21 days
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Primary outcome [2]
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Number of Participants with One or More Adverse Events (AEs)
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Assessment method [2]
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who experience an AE will be presented.
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Timepoint [2]
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Up to approximately 45 months
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Primary outcome [3]
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Number of Participants who Discontinue Study Intervention Due to an AE
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Assessment method [3]
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An AE is defined as any unfavorable and unintended sign, symptom, disease, or worsening of preexisting condition temporally associated with study treatment and irrespective of causality to study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
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Timepoint [3]
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Up to approximately 45 months
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Primary outcome [4]
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Objective Response Rate (ORR)
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Assessment method [4]
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ORR is defined as the percentage of participants with Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
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Timepoint [4]
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Up to approximately 45 months
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Secondary outcome [1]
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Duration of Response (DOR)
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Assessment method [1]
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For participants who demonstrate a confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
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Timepoint [1]
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Up to approximately 45 months
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Secondary outcome [2]
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Progression Free Survival (PFS)
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Assessment method [2]
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PFS is defined as the time from first day of study intervention to the first documented progressive disease (PD) or death due to any cause, whichever occurs first as assessed by BICR. Per RECIST 1.1, PD is defined as =20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of =5 mm. The appearance of one or more new lesions is also considered PD. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
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Timepoint [2]
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Up to approximately 45 months
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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OS is the length of time from when the participant starts treatment until death from any cause.
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Timepoint [3]
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Up to approximately 45 months
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Secondary outcome [4]
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Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
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Assessment method [4]
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Blood samples collected at protocol specific time points will be used to determine the Cmax of patritumab deruxtecan.
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Timepoint [4]
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At designated time points (up to ~45 months)
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Secondary outcome [5]
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Trough Concentration (Ctrough) of Patritumab Deruxtecan
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Assessment method [5]
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Blood samples collected at protocol specific time points will be used to determine the Ctrough of patritumab deruxtecan.
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Timepoint [5]
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At designated time points (up to ~45 months)
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
3/11/2024
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
24/07/2028
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Actual
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Sample size
Target
130
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital ( Site 0100) - Sydney
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Recruitment hospital [2]
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Alfred Health ( Site 0102) - Melbourne
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Recruitment hospital [3]
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Austin Health ( Site 0103) - Melbourne
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Recruitment hospital [4]
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One Clinical Research ( Site 0104) - Mount Pleasant
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Recruitment postcode(s) [1]
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2145 - Sydney
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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3084 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Mount Pleasant
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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District of Columbia
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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United States of America
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Nevada
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United States of America
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New York
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Country [8]
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United States of America
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State/province [8]
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Virginia
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Country [9]
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United States of America
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Wisconsin
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Country [10]
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Canada
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Nova Scotia
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Country [11]
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Canada
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Quebec
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Chile
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Region M. De Santiago
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China
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Anhui
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Country [14]
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China
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Fujian
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China
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Guangdong
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China
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Guangxi
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China
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Henan
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China
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Shanghai
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China
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Shanxi
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France
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Hauts-de-Seine
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France
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Ille-et-Vilaine
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France
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State/province [22]
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Rhone-Alpes
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Israel
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Haifa
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Israel
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Tel Aviv
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Israel
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State/province [25]
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Yerushalayim
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Italy
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State/province [26]
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Milano
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Italy
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Roma
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Korea, Republic of
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Seoul
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New Zealand
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Auckland
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Spain
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Asturias
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Spain
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Barcelona
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Spain
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Madrid
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Switzerland
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Geneve
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Switzerland
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State/province [34]
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Zurich
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Country [35]
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Taiwan
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Tainan
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Taiwan
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Taipei
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Country [37]
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Thailand
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State/province [37]
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Krung Thep Maha Nakhon
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Country [38]
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Turkey
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State/province [38]
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Ankara
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Country [39]
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Turkey
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State/province [39]
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Izmir
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Turkey
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State/province [40]
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Adana
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck Sharp & Dohme LLC
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Daiichi Sankyo
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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
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Trial website
https://clinicaltrials.gov/study/NCT06596694
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Medical Director
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Address
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Merck Sharp & Dohme LLC
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Toll Free Number
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Address
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Country
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Phone
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1-888-577-8839
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06596694
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