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

RECRUITINGPHASE1/PHASE2

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

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

NCT06428409•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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). 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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

•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

Locations (55)

UCLA ( Site 0317)

Los Angeles, California, United States

University of Colorado Anschutz Medical Campus ( Site 0299)

Aurora, Colorado, United States

University of Colorado Anschutz Medical Campus ( Site 0325)

Aurora, Colorado, United States

University of Colorado Anschutz Medical Campus ( Site 0326)

Aurora, Colorado, United States

Sibley Memorial Hospital ( Site 0310)

Washington D.C., District of Columbia, United States

University of Florida College of Medicine ( Site 0281)

Gainesville, Florida, United States

Mount Sinai Cancer Center ( Site 0287)

Miami Beach, Florida, United States

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

Marietta, Georgia, United States

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

Mineola, New York, United States

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

New York, New York, United States

Key Dates

Start Date

June 20, 2024

Primary Completion Date

October 16, 2029

Completion Date

October 16, 2029

Last Updated

January 22, 2026

Enrollment

220

ESTIMATED participants

Conditions

Colorectal CancerPancreatic Ductal AdenocarcinomaBiliary Tract Cancer

Interventions

Sacituzumab tirumotecan

BIOLOGICAL

Fluorouracil (5-FU)

DRUG

Leucovorin (LV) or levoleucovorin

DRUG

Rescue medication

DRUG

Supportive care measures

DRUG

Cisplatin

DRUG

Pembrolizumab

BIOLOGICAL

Contacts

Toll Free Number

CONTACT

1-888-577-8839 Trialsites@msd.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 22, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

Clinical Trial of an Anti-cancer Drug, CA-4948 (Emavusertib), in Combination With Chemotherapy Treatment (FOLFOX Plus Bevacizumab) in Metastatic Colorectal Cancer

Study of Dato-DXd as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Tumours (TROPION-PanTumor03)

Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors

A Study of ART0380 for the Treatment of Advanced or Metastatic Solid Tumors

Study of RAS(ON) Inhibitors in Patients With Gastrointestinal Solid Tumors