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

January 21, 2026 updated by: Merck Sharp & Dohme LLC

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Westmead, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital ( Site 0003)
        • Contact:
          • Study Coordinator
          • Phone Number: +61288908935
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001)
        • Contact:
          • Study Coordinator
          • Phone Number: +61736467712
    • Victoria
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Epworth Freemasons ( Site 0005)
        • Contact:
          • Study Coordinator
          • Phone Number: +61394268996
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Hospital-Oncology and Haematology ( Site 0004)
        • Contact:
          • Study Coordinator
          • Phone Number: +61397848152
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 0002)
        • Contact:
          • Study Coordinator
          • Phone Number: +61862799466
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • The Ottawa Hospital Cancer Centre ( Site 0027)
        • Contact:
          • Study Coordinator
          • Phone Number: 613-737-7700 x70185
    • Quebec
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908000
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • McGill University Health Centre ( Site 0023)
        • Contact:
          • Study Coordinator
          • Phone Number: 514 934-1934
  • Chile
    • Region M. de Santiago
      • Providencia, Region M. de Santiago, Chile, 7500921
        • Recruiting
        • FALP-UIDO ( Site 0041)
        • Contact:
          • Study Coordinator
          • Phone Number: +56228205798
      • Santiago, Region M. de Santiago, Chile, 7620002
        • Recruiting
        • Clínica UC San Carlos de Apoquindo ( Site 0043)
        • Contact:
          • Study Coordinator
          • Phone Number: +56227548924
      • Santiago, Region M. de Santiago, Chile, 8420383
        • Recruiting
        • Bradfordhill-Clinical Area ( Site 0047)
        • Contact:
          • Study Coordinator
          • Phone Number: +56991291852
    • Región de la Araucanía
      • Temuco, Región de la Araucanía, Chile, 4800827
        • Recruiting
        • James Lind Centro de Investigacion del Cancer ( Site 0048)
        • Contact:
          • Study Coordinator
          • Phone Number: +56452982404
  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100142
        • Recruiting
        • Beijing Cancer hospital-Digestive Oncology ( Site 0061)
        • Contact:
          • Study Coordinator
          • Phone Number: 010-88196340
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Recruiting
        • The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Site 0063)
        • Contact:
          • Study Coordinator
          • Phone Number: 0591-22859663
    • Hubei
      • Wuhan, Hubei, China, 430024
        • Recruiting
        • Wuhan Union Hospital Cancer Center. ( Site 0064)
        • Contact:
          • Study Coordinator
          • Phone Number: 027-83262682
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • Hunan Cancer Hospital-intervention department ( Site 0066)
        • Contact:
          • Study Coordinator
          • Phone Number: 0731-89762041
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200127
        • Recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine-Oncology Department ( Site 0067)
        • Contact:
          • Study Coordinator
          • Phone Number: 021-68383223
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • West China Hospital, Sichuan University ( Site 0068)
        • Contact:
          • Study Coordinator
          • Phone Number: 028-85423203
  • Italy
      • Roma, Italy, 00168
        • Recruiting
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS -Medical Oncology ( Site 0103)
        • Contact:
          • Study Coordinator
          • Phone Number: 390458128116
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: 390223903807
      • Milan, Lombardy, Italy, 20162
        • Recruiting
        • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: 390264442291
  • Japan
    • Chiba
      • Kashiwa, Chiba, Japan, 277-8577
        • Recruiting
        • National Cancer Center Hospital East ( Site 0121)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-4-7133-1111
    • Kanagawa
      • Yokohama, Kanagawa, Japan, 241-8515
        • Recruiting
        • Kanagawa Cancer Center ( Site 0122)
        • Contact:
          • Study Coordinator
          • Phone Number: +81-45-520-2222
  • South Korea
      • Seoul, South Korea, 03080
        • Recruiting
        • Seoul National University Hospital ( Site 0161)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2072-0701
      • Seoul, South Korea, 03722
        • Recruiting
        • Severance Hospital, Yonsei University Health System ( Site 0164)
        • Contact:
          • Study Coordinator
          • Phone Number: 82-2-2228-8137
      • Seoul, South Korea, 05505
        • Recruiting
        • Asan Medical Center ( Site 0163)
        • Contact:
          • Study Coordinator
          • Phone Number: +82 2 3010 3945
      • Seoul, South Korea, 06351
        • Recruiting
        • Samsung Medical Center ( Site 0162)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234103549
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 0181)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 93 274 60 60
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28009
        • Recruiting
        • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON-ONCOLOGY ( Site 0183)
        • Contact:
          • Study Coordinator
          • Phone Number: 914269070
    • Principality of Asturias
      • Oviedo, Principality of Asturias, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias-Medical Oncology ( Site 0182)
        • Contact:
          • Study Coordinator
          • Phone Number: 34 985108000x36582
  • Switzerland
    • Canton Ticino
      • Bellinzona, Canton Ticino, Switzerland, 6500
        • Recruiting
        • Ospedale Regionale Bellinzona e Valli ( Site 0201)
        • Contact:
          • Study Coordinator
          • Phone Number: +41918119039
    • Canton of Geneva
      • Geneva, Canton of Geneva, Switzerland, 1211
        • Recruiting
        • Hôpitaux Universitaires de Genève (HUG) ( Site 0202)
        • Contact:
          • Study Coordinator
          • Phone Number: +41223729862
  • Taiwan
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital ( Site 0223)
        • Contact:
          • Study Coordinator
          • Phone Number: +886422052121
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital-Clinical Trial Center ( Site 0224)
        • Contact:
          • Study Coordinator
          • Phone Number: 88662353535
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital-Oncology ( Site 0225)
        • Contact:
          • Study Coordinator
          • Phone Number: +886223123456
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 0221)
        • Contact:
          • Study Coordinator
          • Phone Number: +886228712121
      • Taoyuan District, Taiwan, 33305
        • Recruiting
        • Chang Gung Medical Foundation-Linkou Branch ( Site 0222)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200x8825
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06800
        • Completed
        • Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 0242)
      • Ankara, Turkey (Türkiye), 06230
        • Completed
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)
  • United Kingdom
      • Coventry, United Kingdom, CV2 2DX
        • Recruiting
        • University Hospital Coventry & Warwickshire ( Site 0266)
        • Contact:
          • Study Coordinator
          • Phone Number: 02476967485
    • England
      • London, England, United Kingdom, E1 1RD
        • Recruiting
        • Barts Health NHS Trust ( Site 0263)
        • Contact:
          • Study Coordinator
          • Phone Number: 07918804584
      • London, England, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free Hospital ( Site 0262)
        • Contact:
          • Study Coordinator
          • Phone Number: 02077940500 ext38682
  • United States
    • California
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA ( Site 0317)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-633-8400
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0299)
        • Contact:
          • Study Coordinator
          • Phone Number: 303-724-8644
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0325)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-0300
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Anschutz Medical Campus ( Site 0326)
        • Contact:
          • Study Coordinator
          • Phone Number: 720-848-0300
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Sibley Memorial Hospital ( Site 0310)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-660-6500
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine ( Site 0281)
        • Contact:
          • Study Coordinator
          • Phone Number: 352-265-5121
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Cancer Center ( Site 0287)
        • Contact:
          • Study Coordinator
          • Phone Number: 305-674-2625
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Completed
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0303)
    • New York
      • Mineola, New York, United States, 11501
        • Recruiting
        • Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327)
        • Contact:
          • Study Coordinator
          • Phone Number: 646-599-4083
      • New York, New York, United States, 10016
        • Recruiting
        • Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324)
        • Contact:
          • Study Coordinator
          • Phone Number: 212-731-6000
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • University of Texas MD Anderson Cancer Center ( Site 0316)
        • Contact:
          • Study Coordinator
          • Phone Number: 713-792-2828
    • Virginia
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-491-2240
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293)
        • Contact:
          • Study Coordinator
          • Phone Number: 800-622-8922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 that required steroids or has current pneumonitis/interstitial lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sacituzumab tirumotecan + Chemotherapy
Participants will receive sacituzumab tirumotecan in one of two dose levels and chemotherapy every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Biological: Sacituzumab tirumotecan
Given by IV infusion.
Other Names:
  • SKB264
  • MK-2870
Drug: Fluorouracil (5-FU)
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
Drug: Leucovorin (LV) or levoleucovorin
LV or levoleucovorin is administered by IV infusion every 2 weeks.
Drug: Rescue medication
Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Drug: Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Experimental: Sacituzumab tirumotecan + Cisplatin + Pembrolizumab
Participants will receive sacituzumab tirumotecan in one of two dose levels on Day 1 and Day 8 of every 3-week cycle until the cancer gets worse or they don't tolerate treatment, cisplatin on Day 1 and Day 8 of each 3-week cycle for up to 8 cycles (up to approximately 6 months), and pembrolizumab on Day 1 of each 3-week cycle for up to approximately 2 years.
Biological: Sacituzumab tirumotecan
Given by IV infusion.
Other Names:
  • SKB264
  • MK-2870
Drug: Cisplatin
Given by IV infusion.
Other Names:
  • PLATINOL®
Biological: Pembrolizumab
Given by IV infusion.
Other Names:
  • MK-3475
  • KEYTRUDA®
Drug: Rescue medication
Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Drug: Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Experimental: Sacituzumab tirumotecan
Participants will receive sacituzumab tirumotecan in one of two dose levels every 2 weeks (Day 1 and Day 15 of every 4-week cycle). Participants will continue to receive the treatment until the cancer gets worse or they don't tolerate treatment.
Biological: Sacituzumab tirumotecan
Given by IV infusion.
Other Names:
  • SKB264
  • MK-2870
Drug: Rescue medication
Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 [H1] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Drug: Supportive care measures
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Time Frame: Up to approximately 4 weeks
A DLT is a medical problem related to the study medicine that prevents giving participants a higher dose or may prevent giving the participant the same dose. The number of participants who experience a DLT will be reported.
Up to approximately 4 weeks
Number of Participants Who Experience One or More Adverse Events (AEs)
Time Frame: Up to approximately 63 months
An AE is a health problem that happens or worsens during the study. The number of participants who have an AE during the study will be reported.
Up to approximately 63 months
Number of Participants who Discontinue Study Treatment due to an AE
Time Frame: Up to approximately 63 months
An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.
Up to approximately 63 months
Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 63 months
ORR is defined as the percentage of participants with confirmed Complete Response (CR: disappearance of all target lesions) or Partial Response (PR: at least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1. The percentage of participants who experience CR or PR as assessed by Blinded Independent Central Review (BICR) will be presented.
Up to approximately 63 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR
Time Frame: Up to approximately 63 months
For participants who demonstrate a confirmed Complete Response or Partial Response, DOR is defined as the time from first documented evidence of CR or PR until progressive disease (PD) or death. Per RECIST 1.1, PD is defined as at least a 20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. DOR as assessed by BICR will be presented.
Up to approximately 63 months
Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR
Time Frame: Up to approximately 63 months
PFS is defined as the time from start of study treatment to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. According to RECIST 1.1, PD is defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. The appearance of one or more new lesions is also considered PD. PFS as assessed by BICR will be presented.
Up to approximately 63 months
Overall Survival (OS)
Time Frame: Up to approximately 63 months
OS is the length of time from when the participant starts treatment until death from any cause
Up to approximately 63 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2024

Primary Completion (Estimated)

October 16, 2029

Study Completion (Estimated)

October 16, 2029

Study Registration Dates

First Submitted

May 20, 2024

First Submitted That Met QC Criteria

May 20, 2024

First Posted (Actual)

May 24, 2024

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 21, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9999-02A
  • MK-9999-02A (Other Identifier: MSD)
  • U1111-1298-8273 (Registry Identifier: UTN)
  • jRCT2031240178 (Registry Identifier: jRCT)
  • 2023-508703-21-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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    Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer...
    United States

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