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NCT06428409From ClinicalTrials.govRecruiting

A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A)

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

  • Colorectal Cancer
  • Pancreatic Ductal Adenocarcinoma
  • Biliary Tract Cancer

At a glance

Phase
Phase 1
Study type
Interventional
Sponsor
Merck Sharp & Dohme LLC
Enrolment target
220
Started
20 June 2024
Main results due
16 October 2029
Study sites
55
Registry updated
25 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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 (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

What this study is about

In the sponsor’s own words, from the registry.

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

Study sites(55)

  • 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

  • Sibley Memorial Hospital ( Site 0310)

    Washington D.C., District of Columbia, United States

    Recruiting

  • University of Florida College of Medicine ( Site 0281)

    Gainesville, Florida, United States

    Recruiting

  • Mount Sinai Cancer Center ( Site 0287)

    Miami Beach, Florida, United States

    Recruiting

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)

    Marietta, Georgia, United States

    Completed

  • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)

    Mineola, New York, United States

    Recruiting

  • 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

  • Westmead Hospital ( Site 0003)

    Westmead, New South Wales, Australia

    Recruiting

  • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)

    Brisbane, Queensland, Australia

    Recruiting

  • Epworth Freemasons ( Site 0005)

    East Melbourne, Victoria, Australia

    Recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 0004)

    Frankston, Victoria, Australia

    Recruiting

  • One Clinical Research ( Site 0002)

    Nedlands, Western Australia, Australia

    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

  • McGill University Health Centre ( Site 0023)

    Montreal, Quebec, Canada

    Active, not recruiting

  • James Lind Centro de Investigacion del Cancer ( Site 0048)

    Temuco, Araucania, Chile

    Recruiting

  • FALP-UIDO ( Site 0041)

    Providencia, Region M. de Santiago, Chile

    Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0043)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Bradfordhill-Clinical Area ( Site 0047)

    Santiago, Region M. de Santiago, Chile

    Recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 0061)

    Beijing, Beijing Municipality, China

    Recruiting

  • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)

    Fuzhou, Fujian, China

    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

  • 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

  • Severance Hospital, Yonsei University Health System ( Site 0164)

    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

  • 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

    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

  • China Medical University Hospital ( Site 0223)

    Taichung, Taiwan

    Recruiting

  • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)

    Tainan, Taiwan

    Recruiting

  • National Taiwan University Hospital-Oncology ( Site 0225)

    Taipei, Taiwan

    Recruiting

  • Taipei Veterans General Hospital ( Site 0221)

    Taipei, Taiwan

    Recruiting

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0222)

    Taoyuan, Taiwan

    Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

    Ankara, Turkey (Türkiye)

    Completed

  • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)

    Ankara, Turkey (Türkiye)

    Completed

  • 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

Showing 55 of 55 sites. 47 of the 55 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06428409. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Clinical Study of MK-2870 Alone or With Other Treatments to Treat Gastrointestinal Cancers (MK-9999-02A) | Trialion