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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06428409
Registration number
NCT06428409
Ethics application status
Date submitted
20/05/2024
Date registered
24/05/2024
Date last updated
3/06/2025
Titles & IDs
Public title
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
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Scientific title
A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Monotherapy or in Combination With Other Anticancer Agents in Gastrointestinal Cancers
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Secondary ID [1]
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MK-9999-02A
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Secondary ID [2]
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9999-02A
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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:
Colorectal Cancer
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Pancreatic Ductal Adenocarcinoma
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Biliary Tract Cancer
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Condition category
Condition code
Cancer
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Biliary tree (gall bladder and bile duct)
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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 - Sacituzumab tirumotecan
Treatment: Drugs - Fluorouracil (5-FU)
Treatment: Drugs - Leucovorin (LV) or levoleucovorin
Treatment: Drugs - Rescue medication
Treatment: Drugs - Supportive care measures
Experimental: Sacituzumab tirumotecan + Chemotherapy - Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy by intravenous (IV) infusion, every 2 weeks. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Experimental: Sacituzumab tirumotecan - Participants will receive sacituzumab tirumotecan every 2 weeks via IV infusion. Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate the treatment.
Treatment: Other: Sacituzumab tirumotecan
Given by IV infusion every 2 weeks (Day 1 and Day 15 of every 4-week cycle)
Treatment: Drugs: Fluorouracil (5-FU)
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks
Treatment: Drugs: Leucovorin (LV) or levoleucovorin
LV or levoleucovorin is administered by IV infusion every 2 weeks
Treatment: Drugs: Rescue medication
Participants are allowed to take rescue medication to prevent hypersensitivity and/or infusion reactions as a premedication to study treatment. At the discretion of the investigator, participants are provided with a prescription for rescue medications. Recommended rescue medications are antihistamine, histamine-2 (H2) receptor antagonist, acetaminophen or equivalent, dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) may be given as prophylaxis for stomatitis/oral mucositis.
Treatment: Drugs: Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as a supportive care for Ocular Surface Toxicity.
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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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 Who Experience a Dose-limiting Toxicity (DLT)
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Assessment method [1]
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A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. DLTs will be measured during Cycle 1 (the first 4 weeks) of treatment.
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Timepoint [1]
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Up to approximately 4 weeks
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Primary outcome [2]
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Number of Participants Who Experience One or More Adverse Events (AEs):
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Assessment method [2]
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An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
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Timepoint [2]
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Up to approximately 53 months
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Primary outcome [3]
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Number of Participants who Discontinue Study Treatment due to an AE
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Assessment method [3]
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An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
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Timepoint [3]
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Up to approximately 53 months
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Primary outcome [4]
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Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
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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 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 53 months
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Secondary outcome [1]
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Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
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Assessment method [1]
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For participants who demonstrate a confirmed Complete Response or Partial Response, 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 53 months
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Secondary outcome [2]
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Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
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Assessment method [2]
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PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to 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. PFS as assessed by BICR will be presented.
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Timepoint [2]
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Up to approximately 53 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 53 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 or metastatic pancreatic ductal adenocarcinoma (PDAC)
* Advanced and/or unresectable biliary tract cancer (BTC)
* 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:
* History of severe eye disease
* Received prior systemic anticancer therapy including investigational agents within 4 weeks before starting study intervention
* History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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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
Parallel
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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
20/06/2024
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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
16/10/2029
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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,QLD,VIC,WA
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Recruitment hospital [1]
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Westmead Hospital ( Site 0003) - Westmead
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Recruitment hospital [2]
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Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001) - Brisbane
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Recruitment hospital [3]
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Epworth Freemasons ( Site 0005) - East Melbourne
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Recruitment hospital [4]
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Frankston Hospital-Oncology and Haematology ( Site 0004) - Frankston
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Recruitment hospital [5]
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One Clinical Research ( Site 0002) - Nedlands
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Recruitment postcode(s) [1]
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2145 - Westmead
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Recruitment postcode(s) [2]
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4029 - Brisbane
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Recruitment postcode(s) [3]
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3002 - East Melbourne
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Recruitment postcode(s) [4]
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3199 - Frankston
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Recruitment postcode(s) [5]
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6009 - Nedlands
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Colorado
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United States of America
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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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New York
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United States of America
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Texas
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United States of America
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Virginia
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United States of America
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Wisconsin
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Canada
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Ontario
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Canada
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Quebec
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Chile
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Araucania
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Chile
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Region M. De Santiago
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China
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Beijing
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China
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Fujian
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China
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Hubei
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China
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Hunan
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China
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Shanghai
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China
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Sichuan
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Italy
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Lombardia
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Italy
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Roma
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Japan
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Chiba
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Japan
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Kanagawa
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Korea, Republic of
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Seoul
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Spain
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Asturias
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Spain
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Madrid, Comunidad De
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Spain
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Barcelona
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Switzerland
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Geneve
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Switzerland
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Ticino
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Taiwan
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Taichung
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Taiwan
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Tainan
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Taiwan
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Taipei
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Taiwan
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Taoyuan
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Turkey
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Ankara
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United Kingdom
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England
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United Kingdom
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State/province [36]
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Coventry
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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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Ethics approval
Ethics application status
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Summary
Brief summary
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy can treat certain gastrointestinal (GI) cancers. The GI cancers being studied are either advanced (the cancer has spread to other parts of the body), or unresectable (the cancer cannot be removed with surgery). The goals of this study are to learn: * About the safety and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy * How many people have the cancer respond (get smaller or go away) to treatment
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Trial website
https://clinicaltrials.gov/study/NCT06428409
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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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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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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/NCT06428409
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