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

Recruiting now · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Pancreatic Ductal Adenocarcinoma, Biliary Tract Cancer

In brief

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

Key facts

Study ID

NCT06428409

Run by

Merck Sharp & Dohme LLC

People needed

220

Starts

2024-06-20

Expected to finish

2029-10-16

Last updated by the study team

2026-07-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UCLA ( Site 0317) — Los Angeles, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus ( Site 0325) — Aurora, Colorado, United States (enrolling)
• University of Colorado Anschutz Medical Campus ( Site 0299) — Aurora, Colorado, United States (enrolling)
• Sibley Memorial Hospital ( Site 0310) — Washington D.C., District of Columbia, United States (enrolling)
• University of Florida College of Medicine ( Site 0281) — Gainesville, Florida, United States (enrolling)
• Mount Sinai Cancer Center ( Site 0287) — Miami Beach, Florida, United States (enrolling)
• University of Colorado Anschutz Medical Campus ( Site 0326) — Aurora, Colorado, United States (enrolling)
• Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 0327) — Mineola, New York, United States (enrolling)
• Laura and Isaac Perlmutter Cancer Center at NYU Langone ( Site 0324) — New York, New York, United States (enrolling)
• University of Texas MD Anderson Cancer Center ( Site 0316) — Houston, Texas, United States (enrolling)
• Oncology and Hematology Associates of Southwest Virginia (BRCC) ( Site 0295) — Roanoke, Virginia, United States (enrolling)
• University Hospital and UW Health Clinics-Carbone Cancer Center ( Site 0293) — Madison, Wisconsin, United States (enrolling)
• Westmead Hospital ( Site 0003) — Westmead, New South Wales, Australia (enrolling)
• Royal Brisbane and Women's Hospital-Medical Oncology Clinical Trials Unit, Cancer Care Services ( Site 0001) — Brisbane, Queensland, Australia (enrolling)
• Epworth Freemasons ( Site 0005) — East Melbourne, Victoria, Australia (enrolling)
• Frankston Hospital-Oncology and Haematology ( Site 0004) — Frankston, Victoria, Australia (enrolling)
• One Clinical Research ( Site 0002) — Nedlands, Western Australia, Australia (enrolling)
• The Ottawa Hospital Cancer Centre ( Site 0027) — Ottawa, Ontario, Canada (enrolling)
• Centre Hospitalier de l'Université de Montréal-Unit for Innovative Therapies ( Site 0022) — Montreal, Quebec, Canada (enrolling)
• McGill University Health Centre ( Site 0023) — Montreal, Quebec, Canada (enrolling)
• James Lind Centro de Investigacion del Cancer ( Site 0048) — Temuco, Araucania, Chile (enrolling)
• FALP-UIDO ( Site 0041) — Providencia, Region M. de Santiago, Chile (enrolling)
• Clínica UC San Carlos de Apoquindo ( Site 0043) — Santiago, Region M. de Santiago, Chile (enrolling)
• Bradfordhill-Clinical Area ( Site 0047) — Santiago, Region M. de Santiago, Chile (enrolling)
• Beijing Cancer hospital-Digestive Oncology ( Site 0061) — Beijing, Beijing Municipality, China (enrolling)

Full record on ClinicalTrials.gov

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