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Recruiting Phase 1/2 NCT06428409

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

Phase 1/2 – combined early trial
Conditions: Colorectal Cancer Pancreatic Ductal Adenocarcinoma Biliary Tract Cancer

Sponsor: Merck Sharp & Dohme LLC

trial.available_in: БГ
Overview
Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with other treatments 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 of sacituzumab tirumotecan alone or with other treatments and if people tolerate it * How many people have the cancer respond (get smaller or go away) to treatment
Who can participate
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 and has received prior therapy for the cancer * Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) and has received prior therapy for the cancer * Advanced and/or unresectable biliary tract cancer (BTC) and has received prior therapy for the cancer * Advanced and/or unresectable BTC and has not received prior therapy for the cancer * For participants who have received prior therapy for 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: * History of severe eye disease * For participants who have received prior therapy for cancer: 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
Locations 13
Australia (1)
Westmead Hospital ( Site 0003)
Westmead , New South Wales
Study Coordinator
Canada (1)
The Ottawa Hospital Cancer Centre ( Site 0027)
Ottawa , Ontario
Study Coordinator
Chile (1)
James Lind Centro de Investigacion del Cancer ( Site 0048)
Temuco , Araucania
Study Coordinator
China (1)
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Beijing , Beijing Municipality
Study Coordinator
Italy (1)
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Milan , Lombardy
Study Coordinator
Japan (1)
National Cancer Center Hospital East ( Site 0121)
Kashiwa , Chiba
Study Coordinator
South Korea (1)
Seoul National University Hospital ( Site 0161)
Seoul
Study Coordinator
Spain (1)
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Madrid , Madrid, Comunidad de
Study Coordinator
Switzerland (1)
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva , Canton of Geneva
Study Coordinator
Taiwan (1)
China Medical University Hospital ( Site 0223)
Taichung
Study Coordinator
Turkey (1)
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
Ankara
COMPLETED
United Kingdom (1)
Barts Health NHS Trust ( Site 0263)
London , England
Study Coordinator
United States (1)
UCLA ( Site 0317)
Los Angeles , California
Study Coordinator
Technical details
Status
Recruiting
Phase
Phase 1/2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.06.2024
Completion date
16.10.2029
Registry ID
NCT06428409
Source
anzctr
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