| Title |
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers |
| Protocole ID |
MK-5909-005 (REJOICE-GI01) |
| ClinicalTrials.gov ID |
NCT06864169 |
| Cancer Type(s) |
Colon and Rectum
Hepatic Ducts
Oesophagus
Pancreas
Stomach |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Raludotatug Deruxtecan |
| Institution |
CENTRE HOSPITALIER DE L'UNIVERSITE DE MONTREAL
|
| City |
|
| Principal Investigator |
Dr. Francine Aubin
|
| Coordinator |
Adeline Hamon
514-890-8000 poste 30737
|
| Status |
Recruiting |
| Activation Date |
19-06-2025 |
| Eligibility 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)
|
| Exclusion Criteria |
The main exclusion criteria include but are not limited to the following:
- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis
- Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses
- Has uncontrolled or significant cardiovascular disease
- Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
- Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis
- Active autoimmune disease that has required systemic treatment in the past 2 years
- Has not adequately recovered from major surgery or has ongoing surgical complications
- HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease
|
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Groupe d'étude en oncologie du Québec