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

RecruitingPhase 1/2

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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

About the study

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

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 220 · Started: Jun 20, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06428409

Locations in the U.S.

CaliforniaUCLA ( Site 0317), Los Angeles
ColoradoUniversity of Colorado Anschutz Medical Campus ( Site 0299), Aurora
University of Colorado Anschutz Medical Campus ( Site 0325), Aurora
University of Colorado Anschutz Medical Campus ( Site 0326), Aurora
District of ColumbiaSibley Memorial Hospital ( Site 0310), Washington D.C.
FloridaUniversity of Florida College of Medicine ( Site 0281), Gainesville
Mount Sinai Cancer Center ( Site 0287), Miami Beach
New YorkPerlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327), Mineola
Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324), New York
TexasUniversity of Texas MD Anderson Cancer Center ( Site 0316), Houston
VirginiaOncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295), Roanoke
WisconsinUniversity Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293), Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.