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

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06428409

Patient View

This study evaluates the safety and efficacy of sacituzumab tirumotecan, alone or with chemotherapy, in treating advanced or unresectable GI cancers. Eligible participants have specific GI cancers and have undergone prior therapy. Interventions include sacituzumab tirumotecan, 5-FU, leucovorin, rescue medications, and supportive care to manage treatment-related adverse events.

Patient Parameters

Program Overview

Researchers want to learn if sacituzumab tirumotecan (MK-2870) alone or with chemotherapy 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 and how well people tolerate sacituzumab tirumotecan alone or with chemotherapy
  • How many people have the cancer respond (get smaller or go away) to treatment

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
    • Advanced or metastatic pancreatic ductal adenocarcinoma (PDAC)
    • Advanced and/or unresectable biliary tract cancer (BTC)

  • Has received prior therapy for the 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
  • 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

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