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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

Titles & IDs
Public title
Study of Patritumab Deruxtecan in Participants With Gastrointestinal Cancers (MK-1022-011)
Scientific title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of Patritumab Deruxtecan in Gastrointestinal Cancers
Secondary ID [1] 0 0
MK-1022-011
Secondary ID [2] 0 0
1022-011
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Experiencing Dose-Limiting Toxicity (DLT) (Dose-Escalation Phase)
Timepoint [1] 0 0
Up to 21 days
Primary outcome [2] 0 0
Number of Participants with One or More Adverse Events (AEs)
Timepoint [2] 0 0
Up to approximately 45 months
Primary outcome [3] 0 0
Number of Participants who Discontinue Study Intervention Due to an AE
Timepoint [3] 0 0
Up to approximately 45 months
Primary outcome [4] 0 0
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Timepoint [4] 0 0
Up to approximately 45 months
Secondary outcome [1] 0 0
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Timepoint [1] 0 0
Up to approximately 45 months
Secondary outcome [2] 0 0
Progression Free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Timepoint [2] 0 0
Up to approximately 45 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 45 months
Secondary outcome [4] 0 0
Maximum Plasma Concentration (Cmax) of Patritumab Deruxtecan
Timepoint [4] 0 0
At designated time points (up to ~45 months)
Secondary outcome [5] 0 0
Trough Concentration (Ctrough) of Patritumab Deruxtecan
Timepoint [5] 0 0
At designated time points (up to ~45 months)

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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, 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
3/11/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
24/07/2028
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Alfred Health ( Site 0102) - Melbourne
Recruitment hospital [2] 0 0
One Clinical Research ( Site 0104) - Mount Pleasant
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
6009 - Mount Pleasant
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Georgia
Country [3] 0 0
Chile
State/province [3] 0 0
Region M. De Santiago
Country [4] 0 0
France
State/province [4] 0 0
Ille-et-Vilaine
Country [5] 0 0
Israel
State/province [5] 0 0
Haifa
Country [6] 0 0
Israel
State/province [6] 0 0
Tel Aviv
Country [7] 0 0
Israel
State/province [7] 0 0
Yerushalayim
Country [8] 0 0
Korea, Republic of
State/province [8] 0 0
Seoul
Country [9] 0 0
Spain
State/province [9] 0 0
Madrid
Country [10] 0 0
Switzerland
State/province [10] 0 0
Geneve
Country [11] 0 0
Taiwan
State/province [11] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Daiichi Sankyo
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Medical Director
Address 0 0
Merck Sharp & Dohme LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Toll Free Number
Address 0 0
Country 0 0
Phone 0 0
1-888-577-8839
Fax 0 0
Email 0 0
Trialsites@msd.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: http://engagezone.msd.com/ds_documentation.php


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