Actively Recruiting
A Phase 1/2 Study to Evaluate the Safety and Efficacy of MK-2870 Alone or With Other Agents in Gastrointestinal Cancers
Led by Merck Sharp & Dohme LLC · Updated on 2026-01-22
220
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying sacituzumab tirumotecan, alone or combined with other treatments, to see if it can treat certain advanced or unresectable gastrointestinal cancers, including colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to learn about the safety and tolerance of sacituzumab tirumotecan and how many participants experience a reduction or disappearance of their cancer. Participants receive sacituzumab tirumotecan at one of two dose levels, either alone or with chemotherapy given every two weeks, or with cisplatin and pembrolizumab on a three-week cycle. Treatments continue until the cancer worsens or side effects prevent further treatment. Rescue medications and supportive care are also provided to help manage side effects. During the study, researchers monitor participants for side effects, treatment tolerance, and cancer response using standard criteria. Outcomes include the number of participants experiencing dose-limiting toxicities, adverse events, discontinuation due to side effects, and objective response rates. The study may last up to approximately 63 months, with ongoing safety and efficacy evaluations throughout.
CONDITIONS
Brief Title
A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosed with unresectable or metastatic colorectal cancer, advanced or metastatic pancreatic ductal adenocarcinoma, or advanced/unresectable biliary tract cancer
- Received prior therapy for cancer (except for some biliary tract cancer cases without prior therapy)
- Recovered from side effects of any prior cancer treatment
You will not qualify if you...
- History of severe eye disease
- Received prior systemic anticancer therapy or investigational agents within 4 weeks before starting the study
- History of pneumonitis or interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Until cancer progression or treatment discontinuation
Participants receive sacituzumab tirumotecan alone or with chemotherapy including fluorouracil, leucovorin, cisplatin, and pembrolizumab. Treatments are given by IV infusion in cycles every 2 to 3 weeks depending on the treatment arm. Participants continue treatment until their cancer worsens or they cannot tolerate the treatment.
Visits every 2 weeks or every 3 weeks depending on treatment regimen
Trial Site Locations
Total: 55 locations
1
UCLA ( Site 0317)
Los Angeles, California, United States, 90095
Actively Recruiting
2
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, United States, 80045
Actively Recruiting
3
University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, United States, 80045
Actively Recruiting
4
University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, United States, 80045
Actively Recruiting
5
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, United States, 20016
Actively Recruiting
6
University of Florida College of Medicine ( Site 0281)
Gainesville, Florida, United States, 32610
Actively Recruiting
7
Mount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida, United States, 33140
Actively Recruiting
8
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Marietta, Georgia, United States, 30060
Completed
9
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York, United States, 11501
Actively Recruiting
10
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York, United States, 10016
Actively Recruiting
11
University of Texas MD Anderson Cancer Center ( Site 0316)
Houston, Texas, United States, 77030
Actively Recruiting
12
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Roanoke, Virginia, United States, 24014
Actively Recruiting
13
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Madison, Wisconsin, United States, 53792
Actively Recruiting
14
Westmead Hospital ( Site 0003)
Westmead, New South Wales, Australia, 2145
Actively Recruiting
15
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
Brisbane, Queensland, Australia, 4029
Actively Recruiting
16
Epworth Freemasons ( Site 0005)
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
17
Frankston Hospital-Oncology and Haematology ( Site 0004)
Frankston, Victoria, Australia, 3199
Actively Recruiting
18
One Clinical Research ( Site 0002)
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
19
The Ottawa Hospital Cancer Centre ( Site 0027)
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
20
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
21
McGill University Health Centre ( Site 0023)
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
22
James Lind Centro de Investigacion del Cancer ( Site 0048)
Temuco, Araucania, Chile, 4800827
Actively Recruiting
23
FALP-UIDO ( Site 0041)
Providencia, Region M. de Santiago, Chile, 7500921
Actively Recruiting
24
Clínica UC San Carlos de Apoquindo ( Site 0043)
Santiago, Region M. de Santiago, Chile, 7620002
Actively Recruiting
25
Bradfordhill-Clinical Area ( Site 0047)
Santiago, Region M. de Santiago, Chile, 8420383
Actively Recruiting
26
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Beijing, Beijing Municipality, China, 100142
Actively Recruiting
27
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
Fuzhou, Fujian, China, 350025
Actively Recruiting
28
Wuhan Union Hospital Cancer Center. ( Site 0064)
Wuhan, Hubei, China, 430024
Actively Recruiting
29
Hunan Cancer Hospital-intervention department ( Site 0066)
Changsha, Hunan, China, 410013
Actively Recruiting
30
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
31
West China Hospital, Sichuan University ( Site 0068)
Chengdu, Sichuan, China, 610041
Actively Recruiting
32
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Milan, Lombardy, Italy, 20133
Actively Recruiting
33
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
Milan, Lombardy, Italy, 20162
Actively Recruiting
34
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
Roma, Italy, 00168
Actively Recruiting
35
National Cancer Center Hospital East ( Site 0121)
Kashiwa, Chiba, Japan, 277-8577
Actively Recruiting
36
Kanagawa Cancer Center ( Site 0122)
Yokohama, Kanagawa, Japan, 241-8515
Actively Recruiting
37
Seoul National University Hospital ( Site 0161)
Seoul, South Korea, 03080
Actively Recruiting
38
Severance Hospital, Yonsei University Health System ( Site 0164)
Seoul, South Korea, 03722
Actively Recruiting
39
Asan Medical Center ( Site 0163)
Seoul, South Korea, 05505
Actively Recruiting
40
Samsung Medical Center ( Site 0162)
Seoul, South Korea, 06351
Actively Recruiting
41
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Madrid, Madrid, Comunidad de, Spain, 28009
Actively Recruiting
42
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
Oviedo, Principality of Asturias, Spain, 33011
Actively Recruiting
43
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
Barcelona, Spain, 08035
Actively Recruiting
44
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
45
Ospedale Regionale Bellinzona e Valli ( Site 0201)
Bellinzona, Canton Ticino, Switzerland, 6500
Actively Recruiting
46
China Medical University Hospital ( Site 0223)
Taichung, Taiwan, 404332
Actively Recruiting
47
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
Tainan, Taiwan, 704
Actively Recruiting
48
National Taiwan University Hospital-Oncology ( Site 0225)
Taipei, Taiwan, 10002
Actively Recruiting
49
Taipei Veterans General Hospital ( Site 0221)
Taipei, Taiwan, 112
Actively Recruiting
50
Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
Taoyuan, Taiwan, 33305
Actively Recruiting
51
Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
Ankara, Turkey (Türkiye), 06230
Completed
52
Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
Ankara, Turkey (Türkiye), 06800
Completed
53
Barts Health NHS Trust ( Site 0263)
London, England, United Kingdom, E1 1RD
Actively Recruiting
54
Royal Free Hospital ( Site 0262)
London, England, United Kingdom, NW3 2QG
Actively Recruiting
55
University Hospital Coventry & Warwickshire ( Site 0266)
Coventry, United Kingdom, CV2 2DX
Actively Recruiting
Research Team
T
Toll Free Number
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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