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Colorectal CancerPhase 1/2NCT06428409

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

A Phase 1/2 study testing Sacituzumab tirumotecan, Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin in people with Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 55 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Sacituzumab tirumotecan, Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
220 participants
Where
55 sitesin 13 countries
Study dates
20 Jun 2024to 16 Oct 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

55 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Toll Free Number contact

1-888-577-8839

Trialsites@msd.com

55 sites in 13 countries

United States13 sites, 10 recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0299)

    Aurora, Colorado, 80045

    Study Coordinator, 303-724-8644

    Recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0325)

    Aurora, Colorado, 80045

    Study Coordinator, 720-848-0300

    Recruiting

  • University of Colorado Anschutz Medical Campus ( Site 0326)

    Aurora, Colorado, 80045

    Study Coordinator, 720-848-0300

    Recruiting

  • University of Florida College of Medicine ( Site 0281)

    Gainesville, Florida, 32610

    Study Coordinator, 352-265-5121

    Recruiting

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

    Houston, Texas, 77030

    Study Coordinator, 713-792-2828

    Recruiting

  • UCLA ( Site 0317)

    Los Angeles, California, 90095

    Study Coordinator, 310-633-8400

    Recruiting

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

    Madison, Wisconsin, 53792

    Study Coordinator, 800-622-8922

    Recruiting

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

    Marietta, Georgia, 30060

    Completed

  • Mount Sinai Cancer Center ( Site 0287)

    Miami Beach, Florida, 33140

    Completed

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

    Mineola, New York, 11501

    Study Coordinator, 646-599-4083

    Recruiting

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

    New York, New York, 10016

    Study Coordinator, 212-731-6000

    Recruiting

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

    Roanoke, Virginia, 24014

    Study Coordinator, 540-491-2240

    Recruiting

  • Sibley Memorial Hospital ( Site 0310)

    Washington D.C., District of Columbia, 20016

    Active, not recruiting

Other trials in United States

China6 sites, 2 recruiting

  • Beijing Cancer hospital-Digestive Oncology ( Site 0061)

    Beijing, Beijing Municipality, 100142

    Active, not recruiting

  • Hunan Cancer Hospital-intervention department ( Site 0066)

    Changsha, Hunan, 410013

    Active, not recruiting

  • West China Hospital, Sichuan University ( Site 0068)

    Chengdu, Sichuan, 610041

    Study Coordinator, 028-85423203

    Recruiting

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

    Fuzhou, Fujian, 350025

    Study Coordinator, 0591-22859663

    Recruiting

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

    Shanghai, Shanghai Municipality, 200127

    Active, not recruiting

  • Wuhan Union Hospital Cancer Center. ( Site 0064)

    Wuhan, Hubei, 430024

    Active, not recruiting

Other trials in China

Australia5 sites

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

    Brisbane, Queensland, 4029

    Active, not recruiting

  • Epworth Freemasons ( Site 0005)

    East Melbourne, Victoria, 3002

    Active, not recruiting

  • Frankston Hospital-Oncology and Haematology ( Site 0004)

    Frankston, Victoria, 3199

    Active, not recruiting

  • One Clinical Research ( Site 0002)

    Nedlands, Western Australia, 6009

    Active, not recruiting

  • Westmead Hospital ( Site 0003)

    Westmead, New South Wales, 2145

    Active, not recruiting

Other trials in Australia

Taiwan5 sites

  • China Medical University Hospital ( Site 0223)

    Taichung, 404332

    Active, not recruiting

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

    Tainan, 704

    Active, not recruiting

  • National Taiwan University Hospital-Oncology ( Site 0225)

    Taipei, 10002

    Active, not recruiting

  • Taipei Veterans General Hospital ( Site 0221)

    Taipei, 112

    Active, not recruiting

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

    Taoyuan, 33305

    Active, not recruiting

Other trials in Taiwan

Chile4 sites, 2 recruiting

  • FALP-UIDO ( Site 0041)

    Providencia, Region M. de Santiago, 7500921

    Active, not recruiting

  • Clínica UC San Carlos de Apoquindo ( Site 0043)

    Santiago, Region M. de Santiago, 7620002

    Study Coordinator, +56227548924

    Recruiting

  • Bradfordhill-Clinical Area ( Site 0047)

    Santiago, Region M. de Santiago, 8420383

    Active, not recruiting

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

    Temuco, Araucania, 4800827

    Study Coordinator, +56452982404

    Recruiting

Other trials in Chile

South Korea4 sites, 3 recruiting

  • Seoul National University Hospital ( Site 0161)

    Seoul, 03080

    Study Coordinator, 82-2-2072-0701

    Recruiting

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

    Seoul, 03722

    Active, not recruiting

  • Asan Medical Center ( Site 0163)

    Seoul, 05505

    Study Coordinator, +82 2 3010 3945

    Recruiting

  • Samsung Medical Center ( Site 0162)

    Seoul, 06351

    Study Coordinator, +82234103549

    Recruiting

Other trials in South Korea

Canada3 sites, 2 recruiting

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

    Montreal, Quebec, H2X 0A9

    Study Coordinator, 5148908000

    Recruiting

  • McGill University Health Centre ( Site 0023)

    Montreal, Quebec, H4A 3J1

    Active, not recruiting

  • The Ottawa Hospital Cancer Centre ( Site 0027)

    Ottawa, Ontario, K1H 8L6

    Study Coordinator, 613-737-7700 x70185

    Recruiting

Other trials in Canada

Italy3 sites, 3 recruiting

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

    Milan, Lombardy, 20133

    Study Coordinator, 390223903807

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda ( Site 0102)

    Milan, Lombardy, 20162

    Study Coordinator, 390264442291

    Recruiting

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

    Roma, 00168

    Study Coordinator, 390458128116

    Recruiting

Other trials in Italy

Spain3 sites, 1 recruiting

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

    Barcelona, 08035

    Active, not recruiting

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

    Madrid, Madrid, Comunidad de, 28009

    Study Coordinator, 914269070

    Recruiting

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

    Oviedo, Principality of Asturias, 33011

    Active, not recruiting

Other trials in Spain

United Kingdom3 sites, 3 recruiting

  • University Hospital Coventry & Warwickshire ( Site 0266)

    Coventry, CV2 2DX

    Study Coordinator, 02476967485

    Recruiting

  • Barts Health NHS Trust ( Site 0263)

    London, England, E1 1RD

    Study Coordinator, 07918804584

    Recruiting

  • Royal Free Hospital ( Site 0262)

    London, England, NW3 2QG

    Study Coordinator, 02077940500 ext38682

    Recruiting

Other trials in United Kingdom

Japan2 sites, 2 recruiting

  • National Cancer Center Hospital East ( Site 0121)

    Kashiwa, Chiba, 277-8577

    Study Coordinator, +81-4-7133-1111

    Recruiting

  • Kanagawa Cancer Center ( Site 0122)

    Yokohama, Kanagawa, 241-8515

    Study Coordinator, +81-45-520-2222

    Recruiting

Other trials in Japan

Switzerland2 sites, 2 recruiting

  • Ospedale Regionale Bellinzona e Valli ( Site 0201)

    Bellinzona, Canton Ticino, 6500

    Study Coordinator, +41918119039

    Recruiting

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

    Geneva, Canton of Geneva, 1211

    Study Coordinator, +41223729862

    Recruiting

Other trials in Switzerland

Turkey (Türkiye)2 sites

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 0241)

    Ankara, 06230

    Completed

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

    Ankara, 06800

    Completed

Other trials in Turkey (Türkiye)

About this study

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

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
Being tested
Sacituzumab tirumotecan, Fluorouracil (5-FU), Leucovorin (LV) or levoleucovorin, Rescue medication, Supportive care measures
Medical subject headings
Colorectal Neoplasms, Biliary Tract Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sacituzumab tirumotecanBiological

    Also called MK-2870, SKB264

    Given by IV infusion.

  • Fluorouracil (5-FU)Drug

    5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.

  • Leucovorin (LV) or levoleucovorinDrug

    LV or levoleucovorin is administered by IV infusion every 2 weeks.

  • Rescue medicationDrug

    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.

  • Supportive care measuresDrug

    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.

  • CisplatinDrug

    Also called PLATINOL®

    Given by IV infusion.

  • PembrolizumabBiological

    Also called MK-3475, KEYTRUDA®

    Given by IV infusion.

Study groups in NCT06428409
Study groupRoleWhat they receive
Sacituzumab tirumotecan + ChemotherapyExperimentalParticipants 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.
Receives: Biological: Sacituzumab tirumotecan; Drug: Fluorouracil (5-FU); Drug: Leucovorin (LV) or levoleucovorin; Drug: Rescue medication; Drug: Supportive care measures
Sacituzumab tirumotecanExperimentalParticipants 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.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures
Sacituzumab tirumotecan + Cisplatin + PembrolizumabExperimentalParticipants 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.
Receives: Biological: Sacituzumab tirumotecan; Drug: Rescue medication; Drug: Supportive care measures; Drug: Cisplatin; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Who Experience a Dose-limiting Toxicity (DLT)

    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.

    Measured: Up to approximately 4 weeks

  2. Number of Participants Who Experience One or More Adverse Events (AEs)

    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.

    Measured: Up to approximately 63 months

  3. Number of Participants who Discontinue Study Treatment due to an AE

    An AE is a health problem that happens or worsens during a study. The number of participants who stop study treatment will be reported.

    Measured: Up to approximately 63 months

  4. Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as Assessed by Blinded Independent Central Review (BICR)

    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.

    Measured: Up to approximately 63 months

Secondary outcomes (3)

  1. Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR

    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.

    Measured: Up to approximately 63 months

  2. Progression-free Survival (PFS) per RECIST 1.1 as Assessed by BICR

    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.

    Measured: Up to approximately 63 months

  3. Overall Survival (OS)

    OS is the length of time from when the participant starts treatment until death from any cause

    Measured: Up to approximately 63 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2024
  2. Study start20 Jun 2024
  3. Primary completion16 Oct 2029 (estimated)
  4. Study completion16 Oct 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
220 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06428409
Sponsor's protocol ID
9999-02A
Other IDs
MK-9999-02A, 2023-508703-21-00, U1111-1298-8273, jRCT2031240178, 2023
Status last verified
Oct 2026
First submitted
20 May 2024
Last updated
29 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Sacituzumab tirumotecan, Fluorouracil (5-FU) and Leucovorin (LV) or levoleucovorin in people with Colorectal Cancer and Pancreatic Ductal Adenocarcinoma, run by Merck Sharp & Dohme LLC at 55 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 55 sites in United States, China, Australia, Taiwan, Chile and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Toll Free Number (1-888-577-8839, Trialsites@msd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Who Experience a Dose-limiting Toxicity (DLT) (time frame: Up to approximately 4 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06428409.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.

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