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

RECRUITINGPhase 1/2Sponsored by Merck Sharp & Dohme LLC
Actively Recruiting
PhasePhase 1/2
SponsorMerck Sharp & Dohme LLC
Started2024-06-20
Est. completion2029-10-16
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations13 sites

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 Years+Healthy volunteers accepted
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 that required steroids or has current pneumonitis/interstitial lung disease

Conditions4

Biliary Tract CancerCancerColorectal CancerPancreatic Ductal Adenocarcinoma

Locations13 sites

UCLA ( Site 0317)
Los Angeles, California, 90095
Study Coordinator310-633-8400
University of Colorado Anschutz Medical Campus ( Site 0299)
Aurora, Colorado, 80045
Study Coordinator303-724-8644
University of Colorado Anschutz Medical Campus ( Site 0325)
Aurora, Colorado, 80045
Study Coordinator720-848-0300
University of Colorado Anschutz Medical Campus ( Site 0326)
Aurora, Colorado, 80045
Study Coordinator720-848-0300
Sibley Memorial Hospital ( Site 0310)
Washington D.C., District of Columbia, 20016
Study Coordinator202-660-6500

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