← Back to searchRecruitingRecruiting
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
NCT06428409 · Merck Sharp & Dohme LLC
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official 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
About this study
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 criteria
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
Study design
Enrollment target: 220 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-06-20
Estimated completion: 2029-10-16
Last updated: 2026-01-22
Interventions
Biological: Sacituzumab tirumotecanDrug: Fluorouracil (5-FU)Drug: Leucovorin (LV) or levoleucovorinDrug: Rescue medicationDrug: Supportive care measuresDrug: CisplatinBiological: Pembrolizumab
Primary outcomes
- • Number of Participants Who Experience a Dose-limiting Toxicity (DLT) (Up to approximately 4 weeks)
- • Number of Participants Who Experience One or More Adverse Events (AEs) (Up to approximately 63 months)
- • Number of Participants who Discontinue Study Treatment due to an AE (Up to approximately 63 months)
Sponsor
Merck Sharp & Dohme LLC · industry
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (55)
UCLA ( Site 0317)Recruiting
Los Angeles, California, United States
University of Colorado Anschutz Medical Campus ( Site 0299)Recruiting
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus ( Site 0325)Recruiting
Aurora, Colorado, United States
University of Colorado Anschutz Medical Campus ( Site 0326)Recruiting
Aurora, Colorado, United States
Sibley Memorial Hospital ( Site 0310)Recruiting
Washington D.C., District of Columbia, United States
University of Florida College of Medicine ( Site 0281)Recruiting
Gainesville, Florida, United States
Mount Sinai Cancer Center ( Site 0287)Recruiting
Miami Beach, Florida, United States
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)Completed
Marietta, Georgia, United States
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)Recruiting
Mineola, New York, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)Recruiting
New York, New York, United States
University of Texas MD Anderson Cancer Center ( Site 0316)Recruiting
Houston, Texas, United States
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)Recruiting
Roanoke, Virginia, United States
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)Recruiting
Madison, Wisconsin, United States
Westmead Hospital ( Site 0003)Recruiting
Westmead, New South Wales, Australia
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)Recruiting
Brisbane, Queensland, Australia
Epworth Freemasons ( Site 0005)Recruiting
East Melbourne, Victoria, Australia
Frankston Hospital-Oncology and Haematology ( Site 0004)Recruiting
Frankston, Victoria, Australia
One Clinical Research ( Site 0002)Recruiting
Nedlands, Western Australia, Australia
The Ottawa Hospital Cancer Centre ( Site 0027)Recruiting
Ottawa, Ontario, Canada
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)Recruiting
Montreal, Quebec, Canada
McGill University Health Centre ( Site 0023)Recruiting
Montreal, Quebec, Canada
James Lind Centro de Investigacion del Cancer ( Site 0048)Recruiting
Temuco, Araucania, Chile
FALP-UIDO ( Site 0041)Recruiting
Providencia, Region M. de Santiago, Chile
Clínica UC San Carlos de Apoquindo ( Site 0043)Recruiting
Santiago, Region M. de Santiago, Chile
Bradfordhill-Clinical Area ( Site 0047)Recruiting
Santiago, Region M. de Santiago, Chile
Beijing Cancer hospital-Digestive Oncology ( Site 0061)Recruiting
Beijing, Beijing Municipality, China
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)Recruiting
Fuzhou, Fujian, China
Wuhan Union Hospital Cancer Center. ( Site 0064)Recruiting
Wuhan, Hubei, China
Hunan Cancer Hospital-intervention department ( Site 0066)Recruiting
Changsha, Hunan, China
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)Recruiting
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University ( Site 0068)Recruiting
Chengdu, Sichuan, China
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)Recruiting
Milan, Lombardy, Italy
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)Recruiting
Milan, Lombardy, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)Recruiting
Roma, Italy
National Cancer Center Hospital East ( Site 0121)Recruiting
Kashiwa, Chiba, Japan
Kanagawa Cancer Center ( Site 0122)Recruiting
Yokohama, Kanagawa, Japan
Seoul National University Hospital ( Site 0161)Recruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health System ( Site 0164)Recruiting
Seoul, South Korea
Asan Medical Center ( Site 0163)Recruiting
Seoul, South Korea
Samsung Medical Center ( Site 0162)Recruiting
Seoul, South Korea
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)Recruiting
Madrid, Madrid, Comunidad de, Spain
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)Recruiting
Oviedo, Principality of Asturias, Spain
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)Recruiting
Barcelona, Spain
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)Recruiting
Geneva, Canton of Geneva, Switzerland
Ospedale Regionale Bellinzona e Valli ( Site 0201)Recruiting
Bellinzona, Canton Ticino, Switzerland
China Medical University Hospital ( Site 0223)Recruiting
Taichung, Taiwan
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)Recruiting
Tainan, Taiwan
National Taiwan University Hospital-Oncology ( Site 0225)Recruiting
Taipei, Taiwan
Taipei Veterans General Hospital ( Site 0221)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)Recruiting
Taoyuan District, Taiwan
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)Completed
Ankara, Turkey (Türkiye)
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)Completed
Ankara, Turkey (Türkiye)
Barts Health NHS Trust ( Site 0263)Recruiting
London, England, United Kingdom
Royal Free Hospital ( Site 0262)Recruiting
London, England, United Kingdom
University Hospital Coventry & Warwickshire ( Site 0266)Recruiting
Coventry, United Kingdom