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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
21/11/2024

Titles & IDs
Public title
A Clinical Study of MK-2870 Alone or With Chemotherapy to Treat Gastrointestinal Cancers (MK-9999-02A)
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
Secondary ID [1] 0 0
MK-9999-02A
Secondary ID [2] 0 0
9999-02A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Pancreatic Ductal Adenocarcinoma 0 0
Biliary Tract Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Biliary tree (gall bladder and bile duct)
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 - 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.
Intervention code [1] 0 0
Treatment: Other
Intervention code [2] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Timepoint [1] 0 0
Up to approximately 4 weeks
Primary outcome [2] 0 0
Number of Participants Who Experience One or More Adverse Events (AEs):
Timepoint [2] 0 0
Up to approximately 53 months
Primary outcome [3] 0 0
Number of Participants who Discontinue Study Medication due to an AE
Timepoint [3] 0 0
Up to approximately 53 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 53 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 53 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 53 months
Secondary outcome [3] 0 0
Overall Survival (OS)
Timepoint [3] 0 0
Up to approximately 53 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 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
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:

* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Parallel
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
20/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
3/12/2028
Actual
Sample size
Target
130
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD,VIC
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Si - Brisbane
Recruitment hospital [2] 0 0
Frankston Hospital-Oncology and Haematology ( Site 0004) - Frankston
Recruitment postcode(s) [1] 0 0
4029 - Brisbane
Recruitment postcode(s) [2] 0 0
3199 - Frankston
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
United States of America
State/province [3] 0 0
New York
Country [4] 0 0
United States of America
State/province [4] 0 0
Virginia
Country [5] 0 0
United States of America
State/province [5] 0 0
Wisconsin
Country [6] 0 0
Canada
State/province [6] 0 0
Quebec
Country [7] 0 0
Chile
State/province [7] 0 0
Araucania
Country [8] 0 0
Chile
State/province [8] 0 0
Region M. De Santiago
Country [9] 0 0
China
State/province [9] 0 0
Beijing
Country [10] 0 0
China
State/province [10] 0 0
Fujian
Country [11] 0 0
China
State/province [11] 0 0
Hubei
Country [12] 0 0
China
State/province [12] 0 0
Hunan
Country [13] 0 0
China
State/province [13] 0 0
Sichuan
Country [14] 0 0
Italy
State/province [14] 0 0
Lombardia
Country [15] 0 0
Italy
State/province [15] 0 0
Roma
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Kanagawa
Country [18] 0 0
Korea, Republic of
State/province [18] 0 0
Seoul
Country [19] 0 0
Spain
State/province [19] 0 0
Asturias
Country [20] 0 0
Spain
State/province [20] 0 0
Madrid, Comunidad De
Country [21] 0 0
Spain
State/province [21] 0 0
Barcelona
Country [22] 0 0
Switzerland
State/province [22] 0 0
Geneve
Country [23] 0 0
Switzerland
State/province [23] 0 0
Ticino
Country [24] 0 0
Taiwan
State/province [24] 0 0
Taichung
Country [25] 0 0
Taiwan
State/province [25] 0 0
Tainan
Country [26] 0 0
Taiwan
State/province [26] 0 0
Taipei
Country [27] 0 0
Taiwan
State/province [27] 0 0
Taoyuan
Country [28] 0 0
United Kingdom
State/province [28] 0 0
England
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Coventry

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Merck Sharp & Dohme LLC
Address
Country

Ethics approval
Ethics application status

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
Trial website
https://clinicaltrials.gov/study/NCT06428409
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
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06428409