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
Merck Sharp & Dohme LLC
220 participants
Jun 20, 2024
INTERVENTIONAL
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
Inclusion Criteria6
- 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 Criteria3
- 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
Interventions
Given by IV infusion.
5-FU is administered by IV infusion over 46 to 48 hours every 2 weeks.
LV or levoleucovorin is administered by IV infusion every 2 weeks.
Participants receive the following rescue medications, per approved product label, as premedication to study treatment to prevent hypersensitivity and/or infusion reactions: diphenhydramine (or equivalent histamine-1 \[H1\] receptor antagonist), H2 receptor antagonist, acetaminophen or equivalent, and dexamethasone or equivalent infusion. A steroid mouthwash (dexamethasone or equivalent) will be given as prophylaxis for stomatitis/oral mucositis.
Participants are allowed to take supportive care measures for the management of adverse events associated with study intervention at the discretion of the investigator. Supportive care measures may include but are not limited to antidiarrheal agents and antiemetic agents. Artificial tear drops or gel may be given as supportive care for Ocular Surface Toxicity.
Given by IV infusion.
Given by IV infusion.
Locations(55)
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NCT06428409