Clinical trial Recruiting at 30 sites Phase1; Phase2 Interventional Ages 18 and up

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

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment220 (estimated)
SponsorMerck Sharp & Dohme LLC
Industry-sponsored
Drugs / interventionssacituzumab
Locations55 sites (Los Angeles, California and 54 other locations)
StatusRecruiting
StartedJune 20, 2024
Main results expectedOctober 16, 2029
Study endsOctober 16, 2029
Registry record updatedOctober 29, 2026
Trial IDNCT06428409 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.