Clinical trial • Phase II • Oncology
RALUDOTATUG DERUXTECAN for Gastrointestinal cancers | Pancreatic ductal adenocarcinoma | Cholangiocarcinoma | Gallbladder cancer | Colorectal adenocarcinoma | Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma
Phase II trial of RALUDOTATUG DERUXTECAN for Gastrointestinal cancers | Pancreatic ductal adenocarcinoma | Cholangiocarcinoma | Gallbladder cancer | Color…
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Gastrointestinal cancers | Pancreatic ductal adenocarcinoma | Cholangiocarcinoma | Gallbladder cancer | Colorectal adenocarcinoma | Gastric adenocarcinoma | Gastroesophageal junction adenocarcinoma | Esophageal adenocarcinoma
- Trial Stage
- Phase II
- Drug Modality
- ADC | Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 10-12-2024
- First CTIS Authorization Date
- 27-03-2025
Trial design
open-label, none/not specified-controlled Phase II trial across 9 sites in France, Spain.
- Open Label
- Yes
- Comparator
- None/Not specified
- Target Sample Size
- 143
Eligibility
Recruits 143 isVulnerablePopulationSelected: false. No specific vulnerable population or assent arrangements are described in the available CTIS record..
- Vulnerable Population
- isVulnerablePopulationSelected: false. No specific vulnerable population or assent arrangements are described in the available CTIS record.
Inclusion criteria
- {"criterion_text":"-Has one of the following cancers: • Unresectable or metastatic pancreatic ductal adenocarcinoma (PDAC); • Unresectable or metastatic adenocarcinoma of the biliary tract [intra- or extrahepatic cholangiocarcinoma (CCA) or gallbladder cancer (GBC)]; • Unresectable or metastatic colorectal adenocarcinoma; • unresectable or metastatic gastric adenocarcinoma, gastroesophageal junction adenocarcinoma (GEJAC), or esophageal adenocarcinoma (EAC)"}
- {"criterion_text":"-Has received prior therapy for the cancer"}
- {"criterion_text":"-Has a life expectancy of at least 3 months"}
Exclusion criteria
- {"criterion_text":"-Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids or has current ILD/pneumonitis, and/or suspected ILD/pneumonitis"}
- {"criterion_text":"-Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses"}
- {"criterion_text":"-Has uncontrolled or significant cardiovascular disease"}
- {"criterion_text":"-Has a known additional malignancy that is progressing or has required active treatment within the past 3 years"}
- {"criterion_text":"-Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis"}
- {"criterion_text":"-Has not adequately recovered from major surgery or has ongoing surgical complications"}
Endpoints
Primary endpoints
- {"endpoint_text":"-Objective Response Rate (ORR)","definition_or_measurement_approach":"To evaluate the confirmed ORR per RECIST 1.1 as assessed by BICR"}
Secondary endpoints
- {"endpoint_text":"-Number of Participants who Experience One or More Adverse Events (AEs)","definition_or_measurement_approach":""}
- {"endpoint_text":"-Number of Participants who Discontinue Study Treatment due to an AE","definition_or_measurement_approach":""}
- {"endpoint_text":"-Duration of Response (DOR)","definition_or_measurement_approach":"To evaluate the DOR per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"-Progression Free Survival (PFS)","definition_or_measurement_approach":"To evaluate PFS per RECIST 1.1 as assessed by BICR"}
- {"endpoint_text":"-Overall Survival (OS)","definition_or_measurement_approach":"To evaluate OS"}
Recruitment
- Planned Sample Size
- 143
- Recruitment Window Months
- 11
- Consent Approach
- Informed consent obtained from adult participants. Subject information and informed consent form documents are provided (L1_ICF files) for France and Spain (French and Spanish language ICFs present). No assent arrangements for minors or additional consent procedures are specified in the available record.
Geography
- Total Number Of Sites
- 9
- Total Number Of Participants
- 54
France
- Earliest CTIS Part Ii Submission Date
- 03-12-2024
- Latest Decision Or Authorization Date
- 12-12-2025
- Processing Time Days
- 374
- Number Of Sites
- 4
- Number Of Participants
- 27
Sites
- Site Name
- Institut Regional Du Cancer De Montpellier
- Department Name
- Department of Medical Oncology
- Principal Investigator Name
- Emmanuelle Samalin
- Principal Investigator Email
- emmanuelle.samalin@icm.unicancer.fr
- Contact Person Name
- Emmanuelle Samalin
- Contact Person Email
- emmanuelle.samalin@merck.com
- Site Name
- Centre Francois Baclesse
- Department Name
- Clinical Research Department
- Principal Investigator Name
- Mélanie Dos Santos
- Principal Investigator Email
- m.dossantos@baclesse.unicancer.fr
- Contact Person Name
- Mélanie Dos Santos
- Contact Person Email
- m.dossantos@baclesse.unicancer.fr
- Site Name
- Institut Gustave Roussy
- Department Name
- Department of Therapeutic Innovation and Early Phase Trials
- Principal Investigator Name
- Antoine Hollebecque
- Principal Investigator Email
- antoine.hollebecque@gustaveroussy.fr
- Contact Person Name
- Antoine Hollebecque
- Contact Person Email
- antoine.hollebecque@gustaveroussy.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- Hepato - Gastro - Enterology Department
- Principal Investigator Name
- Jean-Baptste Bachet
- Principal Investigator Email
- jean-baptiste.bachet@aphp.fr
- Contact Person Name
- Jean-Baptste Bachet
- Contact Person Email
- jean-baptiste.bachet@aphp.fr
Spain
- Earliest CTIS Part Ii Submission Date
- 18-02-2025
- Latest Decision Or Authorization Date
- 06-02-2026
- Processing Time Days
- 353
- Number Of Sites
- 5
- Number Of Participants
- 27
Sites
- Site Name
- Hospital General Universitario Gregorio Maranon
- Department Name
- Medical Oncology
- Principal Investigator Name
- Andres Munoz Martin
- Principal Investigator Email
- andresjesus.munoz@salud.madrid.org
- Contact Person Name
- Andres Munoz Martin
- Contact Person Email
- andresjesus.munoz@salud.madrid.org
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Medical Oncology
- Principal Investigator Name
- Angela Lamarca Late
- Principal Investigator Email
- angela.lamarca@quironsalud.es
- Contact Person Name
- Angela Lamarca Late
- Contact Person Email
- angela.lamarca@quironsalud.es
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Medical Oncology
- Principal Investigator Name
- Fernando Rivera Herrero
- Principal Investigator Email
- fernando.rivera@scsalud.es
- Contact Person Name
- Fernando Rivera Herrero
- Contact Person Email
- fernando.rivera@scsalud.es
- Site Name
- Institut Catala D'oncologia
- Department Name
- Medical Oncology
- Principal Investigator Name
- Laura Layos Romero
- Principal Investigator Email
- llayos@iconcologia.net
- Contact Person Name
- Laura Layos Romero
- Contact Person Email
- llayos@iconcologia.net
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Medical Oncology
- Principal Investigator Name
- Tamara Sauri Nadal
- Principal Investigator Email
- sauri@clinic.cat
- Contact Person Name
- Tamara Sauri Nadal
- Contact Person Email
- sauri@clinic.cat
Sponsor
Primary sponsor
- Full Name
- Merck Sharp & Dohme LLC
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United States
Contract research organisations
- Name
- Parexel International Corp.
- Responsibilities
- Medical information (Physician Consulting)
- Name
- Fortrea Inc.
- Responsibilities
- Unblinded monitoring
- Name
- Almac Clinical Services LLC
- Responsibilities
- code 3
- Name
- Perceptive Eclinical Limited
- Responsibilities
- EUB Call center and medical escalation service
Third parties
- {"country":"United States","full_name":"Parexel International Corp.","duties_or_roles":"Medical information (Physician Consulting)","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Unblinded monitoring","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Median Technologies Inc","duties_or_roles":"Imaging","organisation_type":"Industry"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Infinity Biologix LLC","duties_or_roles":"code 4","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Services LLC","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Perceptive Eclinical Limited","duties_or_roles":"EUB Call center and medical escalation service","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Raludotatug Deruxtecan
- Active Substance
- RALUDOTATUG DERUXTECAN
- Modality
- ADC | Monoclonal antibody
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Authorisation Status
- Investigational (Test IMP)
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