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
Status: Recruiting
Location: See all (55) locations...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
∙ 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
Locations
United States
California
UCLA ( Site 0317)
RECRUITING
Los Angeles
Colorado
University of Colorado Anschutz Medical Campus ( Site 0299)
RECRUITING
Aurora
University of Colorado Anschutz Medical Campus ( Site 0325)
RECRUITING
Aurora
University of Colorado Anschutz Medical Campus ( Site 0326)
RECRUITING
Aurora
Washington, D.c.
Sibley Memorial Hospital ( Site 0310)
RECRUITING
Washington D.c.
Florida
University of Florida College of Medicine ( Site 0281)
RECRUITING
Gainesville
Mount Sinai Cancer Center ( Site 0287)
RECRUITING
Miami Beach
Georgia
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
COMPLETED
Marietta
New York
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
RECRUITING
Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
RECRUITING
New York
Texas
University of Texas MD Anderson Cancer Center ( Site 0316)
RECRUITING
Houston
Virginia
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
RECRUITING
Roanoke
Wisconsin
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
RECRUITING
Madison
Other Locations
Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
RECRUITING
Brisbane
Epworth Freemasons ( Site 0005)
RECRUITING
East Melbourne
Frankston Hospital-Oncology and Haematology ( Site 0004)
RECRUITING
Frankston
One Clinical Research ( Site 0002)
RECRUITING
Nedlands
Westmead Hospital ( Site 0003)
RECRUITING
Westmead
Canada
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
RECRUITING
Montreal
McGill University Health Centre ( Site 0023)
RECRUITING
Montreal
The Ottawa Hospital Cancer Centre ( Site 0027)
RECRUITING
Ottawa
Chile
FALP-UIDO ( Site 0041)
RECRUITING
Providencia
Bradfordhill-Clinical Area ( Site 0047)
RECRUITING
Santiago
Clínica UC San Carlos de Apoquindo ( Site 0043)
RECRUITING
Santiago
James Lind Centro de Investigacion del Cancer ( Site 0048)
RECRUITING
Temuco
China
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
RECRUITING
Beijing
Hunan Cancer Hospital-intervention department ( Site 0066)
RECRUITING
Changsha
West China Hospital, Sichuan University ( Site 0068)
RECRUITING
Chengdu
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
RECRUITING
Fuzhou
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
RECRUITING
Shanghai
Wuhan Union Hospital Cancer Center. ( Site 0064)
RECRUITING
Wuhan
Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
RECRUITING
Milan
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
RECRUITING
Milan
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
RECRUITING
Roma
Japan
National Cancer Center Hospital East ( Site 0121)
RECRUITING
Kashiwa
Kanagawa Cancer Center ( Site 0122)
RECRUITING
Yokohama
Republic of Korea
Asan Medical Center ( Site 0163)
RECRUITING
Seoul
Samsung Medical Center ( Site 0162)
RECRUITING
Seoul
Seoul National University Hospital ( Site 0161)
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System ( Site 0164)
RECRUITING
Seoul
Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
RECRUITING
Barcelona
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
RECRUITING
Madrid
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
RECRUITING
Oviedo
Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0201)
RECRUITING
Bellinzona
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
RECRUITING
Geneva
Taiwan
China Medical University Hospital ( Site 0223)
RECRUITING
Taichung
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
RECRUITING
Tainan City
National Taiwan University Hospital-Oncology ( Site 0225)
RECRUITING
Taipei
Taipei Veterans General Hospital ( Site 0221)
RECRUITING
Taipei
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
RECRUITING
Taoyuan District
Turkey
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
RECRUITING
Ankara
United Kingdom
University Hospital Coventry & Warwickshire ( Site 0266)
RECRUITING
Coventry
Barts Health NHS Trust ( Site 0263)
RECRUITING
London
Royal Free Hospital ( Site 0262)
RECRUITING
London
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2029-10-16
Participants
Target number of participants: 180
Treatments
Experimental: Sacituzumab tirumotecan + Chemotherapy
Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). 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 (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Experimental: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab
Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
Related Therapeutic Areas
Sponsors
Leads: Merck Sharp & Dohme LLC