Treatment for advanced gastrointestinal cancers using MK-2870 with or without chemotherapy
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
Run by Merck Sharp & Dohme LLC · NCT06428409 · Data updated 2026-11-12
This study is testing whether a new drug called MK-2870, alone or with chemotherapy, can help people with advanced gastrointestinal cancers like colorectal, pancreatic, or biliary tract cancer feel better and improve their treatment outcomes.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 220 (estimated) |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Drugs / interventions | sacituzumab |
| Locations | 55 sites (Los Angeles, California and 54 other locations) |
| Status | Recruiting |
| Started | June 20, 2024 |
| Main results expected | October 16, 2029 |
| Study ends | October 16, 2029 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT06428409 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals with unresectable or metastatic colorectal cancer, advanced pancreatic ductal adenocarcinoma, or advanced biliary tract cancer who have previously undergone treatment.
✕Probably not a fit
Patients with severe eye disease or those who have had recent systemic anticancer therapy may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical study investigates the effectiveness of sacituzumab tirumotecan (MK-2870) alone or in combination with chemotherapy for patients with advanced or unresectable gastrointestinal cancers, specifically colorectal cancer, pancreatic ductal adenocarcinoma, and biliary tract cancer. The study aims to assess the safety and tolerability of the treatment, as well as the response rate of the cancer to the intervention. Participants will have previously received therapy for their cancer and must have recovered from any side effects before joining the study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat gastrointestinal cancers.
How similar studies have gone: Other studies have shown promise with similar approaches, but the specific combination of MK-2870 with chemotherapy is being explored in this novel context.
Who can join: the full rules
Show full inclusion / exclusion 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 (ILD) that required steroids, has current pneumonitis/ILD, or has suspected ILD or pneumonitis that cannot be ruled out by standard diagnostic assessments at Screening
Where it's running
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UCLA ( Site 0317)
Los Angeles, California, United States Recruiting -
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, United States Recruiting -
University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, United States Recruiting -
University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, United States Recruiting -
University of Florida College of Medicine ( Site 0281)
Gainesville, Florida, United States Recruiting -
Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
Mineola, New York, United States Recruiting
Show 44 more locations
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Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
New York, New York, United States Recruiting -
University of Texas MD Anderson Cancer Center ( Site 0316)
Houston, Texas, United States Recruiting -
Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
Roanoke, Virginia, United States Recruiting -
University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
Madison, Wisconsin, United States Recruiting -
The Ottawa Hospital Cancer Centre ( Site 0027)
Ottawa, Ontario, Canada Recruiting -
Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
Montreal, Quebec, Canada Recruiting -
James Lind Centro de Investigacion del Cancer ( Site 0048)
Temuco, Araucania, Chile Recruiting -
Clínica UC San Carlos de Apoquindo ( Site 0043)
Santiago, Region M. de Santiago, Chile Recruiting -
The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
Fuzhou, Fujian, China Recruiting -
West China Hospital, Sichuan University ( Site 0068)
Chengdu, Sichuan, China Recruiting -
Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
Milan, Lombardy, Italy Recruiting -
ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
Milan, Lombardy, Italy Recruiting -
Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
Roma, Italy Recruiting -
National Cancer Center Hospital East ( Site 0121)
Kashiwa, Chiba, Japan Recruiting -
Kanagawa Cancer Center ( Site 0122)
Yokohama, Kanagawa, Japan Recruiting -
Seoul National University Hospital ( Site 0161)
Seoul, South Korea Recruiting -
Asan Medical Center ( Site 0163)
Seoul, South Korea Recruiting -
Samsung Medical Center ( Site 0162)
Seoul, South Korea Recruiting -
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
Madrid, Madrid, Comunidad de, Spain Recruiting -
Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
Geneva, Canton of Geneva, Switzerland Recruiting -
Ospedale Regionale Bellinzona e Valli ( Site 0201)
Bellinzona, Canton Ticino, Switzerland Recruiting -
Barts Health NHS Trust ( Site 0263)
London, England, United Kingdom Recruiting -
Royal Free Hospital ( Site 0262)
London, England, United Kingdom Recruiting -
University Hospital Coventry & Warwickshire ( Site 0266)
Coventry, United Kingdom Recruiting -
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, United States Active not recruiting -
Mount Sinai Cancer Center ( Site 0287)
Miami Beach, Florida, United States Completed -
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
Marietta, Georgia, United States Completed -
Westmead Hospital ( Site 0003)
Westmead, New South Wales, Australia Active not recruiting -
Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
Brisbane, Queensland, Australia Active not recruiting -
Epworth Freemasons ( Site 0005)
East Melbourne, Victoria, Australia Active not recruiting -
Frankston Hospital-Oncology and Haematology ( Site 0004)
Frankston, Victoria, Australia Active not recruiting -
One Clinical Research ( Site 0002)
Nedlands, Western Australia, Australia Active not recruiting -
McGill University Health Centre ( Site 0023)
Montreal, Quebec, Canada Active not recruiting -
FALP-UIDO ( Site 0041)
Providencia, Region M. de Santiago, Chile Active not recruiting -
Bradfordhill-Clinical Area ( Site 0047)
Santiago, Region M. de Santiago, Chile Active not recruiting -
Beijing Cancer hospital-Digestive Oncology ( Site 0061)
Beijing, Beijing Municipality, China Active not recruiting -
Wuhan Union Hospital Cancer Center. ( Site 0064)
Wuhan, Hubei, China Active not recruiting -
Hunan Cancer Hospital-intervention department ( Site 0066)
Changsha, Hunan, China Active not recruiting -
Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
Shanghai, Shanghai Municipality, China Active not recruiting -
Severance Hospital, Yonsei University Health System ( Site 0164)
Seoul, South Korea Active not recruiting -
Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
Oviedo, Principality of Asturias, Spain Active not recruiting -
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
Barcelona, Spain Active not recruiting -
China Medical University Hospital ( Site 0223)
Taichung, Taiwan Active not recruiting -
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
Tainan, Taiwan Active not recruiting
+5 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.