New treatment for advanced gastrointestinal cancers using Raludotatug Deruxtecan
A Phase 2 Nonrandomized, Open-label, Multisite Study to Evaluate the Safety and Efficacy of Raludotatug Deruxtecan in Participants With Gastrointestinal Cancers
This study is testing a new treatment called Raludotatug Deruxtecan for people with advanced gastrointestinal cancers to see if it can help shrink or eliminate their tumors.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Merck Sharp & Dohme LLC Industry-sponsored |
| Locations | 16 sites (Miami Beach, Florida and 15 other locations) |
| Trial ID | NCT06864169 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of Raludotatug Deruxtecan (R-DXd), an antibody-drug conjugate, in treating advanced gastrointestinal cancers. The treatment targets specific proteins on cancer cells to deliver therapeutic agents directly, aiming to shrink or eliminate tumors. Participants will include individuals with various types of unresectable or metastatic gastrointestinal cancers who have previously undergone therapy. The primary objective is to assess the cancer's response to this novel treatment approach.
Who should consider this trial
Good fit: Ideal candidates include individuals with unresectable or metastatic gastrointestinal cancers who have received prior therapy.
Not a fit: Patients with a history of noninfectious interstitial lung disease or current lung issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced gastrointestinal cancers.
How similar studies have performed: Other studies using antibody-drug conjugates have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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) 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
Where this trial is running
Miami Beach, Florida and 15 other locations
- Mt Sinai Comprehensive Cancer Center ( Site 0345) — Miami Beach, Florida, United States (Recruiting)
- St. Vincent Healthcare Frontier Cancer Center ( Site 0347) — Billings, Montana, United States (Recruiting)
- University of Wisconsin Carbone Cancer Center ( Site 0348) — Madison, Wisconsin, United States (Recruiting)
- Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0006) — La Rioja, Argentina (Recruiting)
- FALP ( Site 0062) — Santiago., Region M. De Santiago, Chile (Recruiting)
- Centro de Estudios Clínicos SAGA ( Site 0064) — Santiago, Region M. De Santiago, Chile (Recruiting)
- Clínica UC San Carlos de Apoquindo ( Site 0066) — Santiago, Region M. De Santiago, Chile (Recruiting)
- Bradfordhill ( Site 0069) — Santiago, Region M. De Santiago, Chile (Recruiting)
- Gustave Roussy ( Site 0081) — Villejuif, Val-de-Marne, France (Recruiting)
- Prince of Wales Hospital ( Site 0122) — Hong Kong, Hong Kong (Recruiting)
- Queen Mary Hospital ( Site 0121) — Hong Kong, Hong Kong (Recruiting)
- Institut Català d'Oncologia (ICO) - Badalona ( Site 0222) — Badalona, Barcelona, Spain (Recruiting)
- Hospital Universitario Marqués de Valdecilla ( Site 0221) — Santander, Cantabria, Spain (Recruiting)
- Hospital Clinic de Barcelona ( Site 0223) — Barcelona, Spain (Recruiting)
- Hospital General Universitario Gregorio Marañón ( Site 0225) — Madrid, Spain (Recruiting)
- Mackay Memorial Hospital ( Site 0266) — Taipei, Taiwan (Recruiting)
Study contacts
- Study coordinator: Toll Free Number
- Email: Trialsites@msd.com
- Phone: 1-888-577-8839
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.