Title
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

Description
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

Objective
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

Treatment This is a Phase 1/2, nonrandomized, multisite, open-label study of MK-2870 monotherapy or in combination with other anticancer agents in GI cancers. Specific details regarding the eligibility criteria for each tumor type can be found in Section 5.

Approximately 130 eligible participants will be nonrandomly allocated to one of the following study intervention arms depending on disease cohort:

-Cohort 1: 2L CRC (up to approximately 50 participants, including dose escalation)
-Cohort 2: 2L PDAC (approximately 40 participants)
-Cohort 3: 2L+ BTC (approximately 40 participants)

Key Eligibility 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

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

Applicable Disease Sites
Colon and Rectum; Gastrointestinal cancers, other; Pancreas

Participating Institutions
UW Health Eastpark Medical Center; UW Health University Hospital