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New drug combo shows promise for Tough-to-Treat GI cancers

NCT ID NCT06428409

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Sep 18, 2026 · Updated 7 times

Summary

This study is testing a new biologic drug called sacituzumab tirumotecan (MK-2870), alone or with chemotherapy, in people with advanced colorectal, pancreatic, or biliary tract cancers that cannot be removed by surgery. The main goals are to check safety and see if tumors shrink. About 220 participants will be enrolled.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Sacituzumab tirumotecan (MK-2870), a biologic drug given by IV infusion, sometimes combined with chemotherapy drugs (fluorouracil, leucovorin) and rescue medications.
What this could lead to
If successful, this could provide a new treatment option for people with advanced gastrointestinal cancers that have not responded to prior therapies.
What could go wrong
This is an early-phase trial (Phase 1/2) with a small number of participants, so the drug may not work as hoped or could cause significant side effects. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 220 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

biliary tract cancer Biliary Tract Neoplasms colorectal cancer colorectal neoplasm pancreatic ductal adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Biliary tract cancer Colorectal cancer Pancreatic ductal adenocarcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    50 sites in 12 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)

    RECRUITING

    Milan, Lombardy, 20162, Italy

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

    COMPLETED

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center ( Site 0163)

    RECRUITING

    Seoul, 05505, South Korea

  • Barts Health NHS Trust ( Site 0263)

    RECRUITING

    London, England, E1 1RD, United Kingdom

  • Beijing Cancer hospital-Digestive Oncology ( Site 0061)

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Bradfordhill-Clinical Area ( Site 0047)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)

    RECRUITING

    Montreal, Quebec, H2X 0A9, Canada

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

    RECRUITING

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital ( Site 0223)

    RECRUITING

    Taichung, 404332, Taiwan

  • Clínica UC San Carlos de Apoquindo ( Site 0043)

    RECRUITING

    Santiago, Region M. de Santiago, 7620002, Chile

  • Epworth Freemasons ( Site 0005)

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • FALP-UIDO ( Site 0041)

    RECRUITING

    Providencia, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)

    RECRUITING

    Roma, 00168, Italy

  • Frankston Hospital-Oncology and Haematology ( Site 0004)

    RECRUITING

    Frankston, Victoria, 3199, Australia

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)

    RECRUITING

    Madrid, Madrid, Comunidad de, 28009, Spain

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

    COMPLETED

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)

    ACTIVE_NOT_RECRUITING

    Oviedo, Principality of Asturias, 33011, Spain

  • Hunan Cancer Hospital-intervention department ( Site 0066)

    RECRUITING

    Changsha, Hunan, 410013, China

  • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)

    RECRUITING

    Geneva, Canton of Geneva, 1211, Switzerland

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

    RECRUITING

    Temuco, Araucania, 4800827, Chile

  • Kanagawa Cancer Center ( Site 0122)

    RECRUITING

    Yokohama, Kanagawa, 241-8515, Japan

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)

    RECRUITING

    New York, New York, 10016, United States

  • McGill University Health Centre ( Site 0023)

    RECRUITING

    Montreal, Quebec, H4A 3J1, Canada

  • Mount Sinai Cancer Center ( Site 0287)

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • National Cancer Center Hospital East ( Site 0121)

    RECRUITING

    Kashiwa, Chiba, 277-8577, Japan

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

    RECRUITING

    Tainan, 704, Taiwan

  • National Taiwan University Hospital-Oncology ( Site 0225)

    RECRUITING

    Taipei, 10002, Taiwan

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

    COMPLETED

    Marietta, Georgia, 30060, United States

  • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)

    RECRUITING

    Roanoke, Virginia, 24014, United States

  • One Clinical Research ( Site 0002)

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ospedale Regionale Bellinzona e Valli ( Site 0201)

    RECRUITING

    Bellinzona, Canton Ticino, 6500, Switzerland

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

    RECRUITING

    Mineola, New York, 11501, United States

  • Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)

    ACTIVE_NOT_RECRUITING

    Shanghai, Shanghai Municipality, 200127, China

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

    RECRUITING

    Brisbane, Queensland, 4029, Australia

  • Royal Free Hospital ( Site 0262)

    RECRUITING

    London, England, NW3 2QG, United Kingdom

  • Samsung Medical Center ( Site 0162)

    RECRUITING

    Seoul, 06351, South Korea

  • Seoul National University Hospital ( Site 0161)

    RECRUITING

    Seoul, 03080, South Korea

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

    RECRUITING

    Seoul, 03722, South Korea

  • Sibley Memorial Hospital ( Site 0310)

    RECRUITING

    Washington D.C., District of Columbia, 20016, United States

  • Taipei Veterans General Hospital ( Site 0221)

    RECRUITING

    Taipei, 112, Taiwan

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

    RECRUITING

    Fuzhou, Fujian, 350025, China

  • The Ottawa Hospital Cancer Centre ( Site 0027)

    RECRUITING

    Ottawa, Ontario, K1H 8L6, Canada

  • UCLA ( Site 0317)

    RECRUITING

    Los Angeles, California, 90095, United States

  • University Hospital Coventry & Warwickshire ( Site 0266)

    RECRUITING

    Coventry, CV2 2DX, United Kingdom

  • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)

    RECRUITING

    Madison, Wisconsin, 53792, United States

  • University of Colorado Anschutz Medical Campus ( Site 0299)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Colorado Anschutz Medical Campus ( Site 0325)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Colorado Anschutz Medical Campus ( Site 0326)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Florida College of Medicine ( Site 0281)

    RECRUITING

    Gainesville, Florida, 32610, United States

  • University of Texas MD Anderson Cancer Center ( Site 0316)

    RECRUITING

    Houston, Texas, 77030, United States

  • West China Hospital, Sichuan University ( Site 0068)

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Westmead Hospital ( Site 0003)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Wuhan Union Hospital Cancer Center. ( Site 0064)

    RECRUITING

    Wuhan, Hubei, 430024, China

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