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

Last updated: May 15, 2025
Sponsor: Merck Sharp & Dohme LLC
Overall Status: Active - Recruiting

Phase

1/2

Condition

Rectal Cancer

Pancreatic Cancer

Gall Bladder Cancer

Treatment

Fluorouracil (5-FU)

Supportive care measures

Leucovorin (LV) or levoleucovorin

Clinical Study ID

NCT06428409
9999-02A
MK-9999-02A
jRCT2031240178
2023-508703-21
U1111-1298-8273
  • Ages > 18
  • All Genders

Study Summary

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy 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 and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy

  • How many people have the cancer respond (get smaller or go away) to treatment

Eligibility Criteria

Inclusion

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

  • Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)

  • Advanced and/or unresectable biliary tract cancer (BTC)

  • Has received prior therapy for the cancer

  • Has recovered from any side effects due to previous cancer treatment

Exclusion

Exclusion Criteria:

The main exclusion criteria include but are not limited to the following:

  • History of severe eye disease

  • Received prior systemic anticancer therapy including investigational agents within 4weeks before starting study intervention

  • History of (noninfectious) pneumonitis/interstitial lung disease that requiredsteroids or has current pneumonitis/interstitial lung disease

Study Design

Total Participants: 130
Treatment Group(s): 5
Primary Treatment: Fluorouracil (5-FU)
Phase: 1/2
Study Start date:
June 20, 2024
Estimated Completion Date:
October 16, 2029

Connect with a study center

  • Westmead Hospital ( Site 0003)

    Westmead, New South Wales 2145
    Australia

    Active - Recruiting

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

    Brisbane, Queensland 4029
    Australia

    Active - Recruiting

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

    Brisbane, Queensland 4029
    Australia

    Active - Recruiting

  • Epworth Freemasons ( Site 0005)

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 0004)

    Frankston, Victoria 3199
    Australia

    Active - Recruiting

  • One Clinical Research ( Site 0002)

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • The Ottawa Hospital Cancer Centre ( Site 0027)

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

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

    Montréal, Quebec H2X 0A9
    Canada

    Active - Recruiting

  • McGill University Health Centre ( Site 0023)

    Montréal, Quebec H4A 3J1
    Canada

    Active - Recruiting

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

    Temuco, Araucania 4800827
    Chile

    Active - Recruiting

  • FALP-UIDO ( Site 0041)

    Providencia, Region M. De Santiago 7500921
    Chile

    Active - Recruiting

  • Bradfordhill-Clinical Area ( Site 0047)

    Santiago, Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0043)

    Santiago, Region M. De Santiago 7620002
    Chile

    Active - Recruiting

  • Bradfordhill-Clinical Area ( Site 0047)

    Santiago., Region M. De Santiago 8420383
    Chile

    Active - Recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 0061)

    Beijing, Beijing 100142
    China

    Active - Recruiting

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

    Fuzhou, Fujian 350025
    China

    Active - Recruiting

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

    Fuzhou, Fujian 350025
    China

    Active - Recruiting

  • Wuhan Union Hospital Cancer Center-Cancer Center ( Site 0064)

    Wuhan, Hubei 430022
    China

    Active - Recruiting

  • Wuhan Union Hospital Cancer Center. ( Site 0064)

    Wuhan, Hubei 430024
    China

    Active - Recruiting

  • Hunan Cancer Hospital-intervention department ( Site 0066)

    Changsha, Hunan 410013
    China

    Active - Recruiting

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

    Shanghai, Shanghai 200127
    China

    Active - Recruiting

  • West China Hospital, Sichuan University ( Site 0068)

    Cheng Du, Sichuan 610041
    China

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)

    Milan, Lombardia 20162
    Italy

    Active - Recruiting

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

    Milan, Lombardia 20133
    Italy

    Active - Recruiting

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

    Roma, 00168
    Italy

    Active - Recruiting

  • National Cancer Center Hospital East ( Site 0121)

    Kashiwa, Chiba 277-8577
    Japan

    Active - Recruiting

  • Kanagawa Cancer Center ( Site 0122)

    Yokohama, Kanagawa 241-8515
    Japan

    Active - Recruiting

  • Asan Medical Center ( Site 0163)

    Seoul, 05505
    Korea, Republic of

    Active - Recruiting

  • Samsung Medical Center ( Site 0162)

    Seoul, 06351
    Korea, Republic of

    Active - Recruiting

  • Seoul National University Hospital ( Site 0161)

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

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

    Seoul, 03722
    Korea, Republic of

    Active - Recruiting

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

    Oviedo, Asturias 33011
    Spain

    Active - Recruiting

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

    Madrid, Madrid, Comunidad De 28009
    Spain

    Active - Recruiting

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

    Barcelona, 08035
    Spain

    Active - Recruiting

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

    Genève, Geneve 1211
    Switzerland

    Active - Recruiting

  • Ospedale Regionale Bellinzona e Valli ( Site 0201)

    Bellinzona, Ticino 6500
    Switzerland

    Active - Recruiting

  • China Medical University Hospital ( Site 0223)

    Taichung, 404332
    Taiwan

    Active - Recruiting

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

    Tainan, 704
    Taiwan

    Active - Recruiting

  • National Taiwan University Hospital-Oncology ( Site 0225)

    Taipei, 10002
    Taiwan

    Active - Recruiting

  • Taipei Veterans General Hospital ( Site 0221)

    Taipei, 112
    Taiwan

    Active - Recruiting

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

    Taoyuan, 33305
    Taiwan

    Active - Recruiting

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

    Ankara, 06800
    Turkey

    Active - Recruiting

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

    Ankara, 06230
    Turkey

    Active - Recruiting

  • Barts Health NHS Trust ( Site 0263)

    London, England E1 1RD
    United Kingdom

    Active - Recruiting

  • Royal Free Hospital ( Site 0262)

    London, England NW3 2QG
    United Kingdom

    Active - Recruiting

  • University Hospital Coventry & Warwickshire ( Site 0266)

    Coventry, CV2 2DX
    United Kingdom

    Active - Recruiting

  • UCLA ( Site 0317)

    Los Angeles, California 90095
    United States

    Active - Recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0299)

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • UCHealth Cherry Creek Medical Center ( Site 0326)

    Denver, Colorado 80206
    United States

    Active - Recruiting

  • UCHealth Highlands Ranch Hospital ( Site 0325)

    Highlands Ranch, Colorado 80129
    United States

    Active - Recruiting

  • Sibley Memorial Hospital ( Site 0310)

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • University of Florida College of Medicine ( Site 0281)

    Gainesville, Florida 32610
    United States

    Active - Recruiting

  • Mount Sinai Cancer Center ( Site 0287)

    Miami Beach, Florida 33140
    United States

    Active - Recruiting

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

    Marietta, Georgia 30060
    United States

    Active - Recruiting

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

    Mineola, New York 11501
    United States

    Active - Recruiting

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

    New York, New York 10016
    United States

    Active - Recruiting

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

    Houston, Texas 77030
    United States

    Active - Recruiting

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

    Roanoke, Virginia 24014
    United States

    Active - Recruiting

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

    Madison, Wisconsin 53792
    United States

    Active - Recruiting

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