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

About

Brief 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
Primary Purpose
Treatment
Study Type
Interventional
Phase
Phase 1/Phase 2

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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
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Study Stats
Protocol No.
24-5237
Category
Adolescent & Young Adults (AYA)
Colorectal Cancer
Liver Cancer
Pancreatic Cancer
Location
  • UCLA Santa Monica
  • UCLA Westwood
For Providers
NCT No.
NCT06428409
For detailed technical eligibility, visit ClinicalTrials.gov.