Title
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

Description
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers

Objective
Primacy Objective - To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR

Secondary Objectives
-To evaluate the safety and tolerability of R-DXd
-To evaluate the DOR per RECIST 1.1 as assessed by BICR
-To evaluate PFS per RECIST 1.1 as assessed by BICR
-To evaluate OS

Treatment Researchers are looking for new ways to treat certain types of advanced gastrointestinal (GI) cancers. The study medicine raludotatug deruxtecan (also called MK-5909, R-DXd, or DS-6000a) is a type of medicine called an antibody-drug conjugate (ADC). An ADC attaches to a protein on cancer cells and delivers treatment to destroy those cells.

The main goal of this study is to learn if the cancer responds to treatment (gets smaller or goes away).

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 pancreatic ductal adenocarcinoma (PDAC)

Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic holangiocarcinoma (CCA) or gallbladder cancer (GBC)]

Unresectable or metastatic colorectal adenocarcinoma

Unresectable or metastatic gastric adenocarcinoma

Gastroesophageal junction adenocarcinoma (GEJAC)

Esophageal adenocarcinoma (EAC)



Has received prior therapy for the cancer

Has a life expectancy of at least 3 months

If human immunodeficiency virus (HIV) infected, must have well controlled HIV on antiretroviral therapy (ART)

Applicable Disease Sites
Colon and Rectum; Esophagus; Pancreas

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