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Study of Sacituzumab Tirumotecan for Gastrointestinal Cancers

This study is looking into whether sacituzumab tirumotecan (MK-2870), alone or with other treatments like fluorouracil (5-FU) and leucovorin, can help treat certain advanced or unresectable gastrointestinal (GI) cancers. These include colorectal cancer, pancreatic ductal adenocarcinoma (PDAC), and biliary tract cancer, for which you would have already received prior therapy. Researchers want to understand how safe these treatments are, if people can tolerate them, and if the cancer shrinks or goes away. The study plans to enroll about 220 people aged 18 and older. The current status of the study is unclear.

Study design
This is an interventional study, meaning participants will receive specific treatments. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor participants for adverse events and discontinuation from study treatment for up to approximately 63 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06428409

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~220 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Sacituzumab tirumotecanFluorouracil (5-FU)Leucovorin (LV) or levoleucovorinRescue medicationSupportive care measuresCisplatin

At a glance

Recruiting sites
52 of 55 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of Participants Who Experience a Dose-limiting Toxicity (DLT)
Measured over Up to approximately 4 weeks
+3 more outcomes measured

Conditions

Colorectal Cancer
Pancreatic Ductal Adenocarcinoma
Biliary Tract Cancer

Explore related trials

Colorectal CarcinomaMalignant neoplasm of biliary tractPancreatic Ductal Adenocarcinoma

Where it's being run

55 sites across 37 states
Taiwan5
South Korea4
Colorado3
Region M. de Santiago3
Florida2
New York2
Victoria2
Quebec2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

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

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

  • Number of Participants who Discontinue Study Treatment due to an AEUp 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.

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