Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

Estado del programa

Reclutamiento

Fase

Fase 1

Inmunoterapia previa permitida

Ensayo dirigido por el CRC

Drogas

M9140

Etiquetas

MSI-H/ MMRd, MSS/ MMRp

Comentarios

M9140 is an ADC (antibody-drug conjugate) that is designed to deliver a cytotoxic topoisomerase 1 (TOP1) inhibitor payload to CEACAM5-expressing tumor cells. CEACAM5 is a a cell surface protein with limited expression in adult healthy tissues but with high expression in various adenocarcinomas, particularly in colorectal cancer: it is found I over 90% of the CRC cancers.

Results reported at ASCO 2024: Best objective response was partial response (PR) in 4 patients; stable disease (SD) in 17 , including 6 lasting for ≥100 days and progressive disease (PD) in 6 patients.  

Ubicación Situación
Estados Unidos
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California 92024
Reclutamiento
California Cancer Associates for Research & Excellence, Inc.
Fresno, California 93720
Reclutamiento
Rhode Island Hospital
Providence, Rhode Island 02903
Reclutamiento
Mary Crowley Cancer Research
Dallas, Texas 75230
Reclutamiento
MD Anderson Cancer Center - Oncology
Houston, Texas 77030
Reclutamiento
NEXT Oncology
San Antonio, Texas 78229
Reclutamiento
Canadá
Centro Oncológico del Hospital de Ottawa
Ottawa
Reclutamiento
University Health Network - Princess Margaret Cancer Centre
Toronto
Reclutamiento
Japón
National Cancer Center Hospital - Dept of Gastroenterology
Chuo-ku
Reclutamiento
Centro Nacional del Cáncer Hospital Este
Kashiwa-shi
Reclutamiento
Saitama Cancer Center
Kitaadachi-gun
Reclutamiento
Cancer Institute Hospital of JFCR
Koto-ku
Reclutamiento
Aichi Cancer Center Hospital
Nagoya-shi
Reclutamiento
Hospital Universitario Kindai
Osakasayama-shi
Reclutamiento
Shizuoka Cancer Center
Sunto-gun
Reclutamiento
Kanagawa Cancer Center
Yokohama-shi
Reclutamiento
Corea, República de
Kyungpook National University Chilgok Hospital
Daegu
Reclutamiento
National Cancer Center
Goyang-si
Reclutamiento
Seoul National University Bundang Hospital
Seongnam
Reclutamiento
Centro Médico Asan
Seoul
Reclutamiento
Centro Médico Samsung
Seoul
Reclutamiento
Seoul National University Hospital
Seoul
Reclutamiento
Hospital Severance, Sistema de Salud de la Universidad de Yonsei
Seoul
Reclutamiento
España
Hospital Clinic de Barcelona
Barcelona
Reclutamiento
Hospital del Mar
Barcelona
Reclutamiento
Hospital HM Nou Delfos
Barcelona
Reclutamiento
Hospital Universitari Vall d'Hebron - VHIR
Barcelona
Reclutamiento
Hospital Universitario Reina Sofia
Cordoba
Reclutamiento
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat
Reclutamiento
Centro Integral Oncologico Clara Campal
Madrid
Reclutamiento
Hospital Universitario 12 de Octubre
Madrid
Reclutamiento
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Reclutamiento
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid
Reclutamiento
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Reclutamiento
Hospital Universitario Virgen del Rocio
Sevilla
Reclutamiento

Contactos

US Medical Information
CONTACTO
888-275-7376 eMediUSA@emdserono.com
Communication Center
CONTACTO
+49 6151 72 5200 service@emdgroup.com

Criterios de inclusión

Criterios de inclusión:

* Participants with documented histopathological diagnosis of locally advanced or metastatic colorectal cancer (CRC), who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage, if locally indicated and available to the participant. Participants with a known microsatellite instability high (MSI-H) status must have received treatment with an immune checkpoint inhibitor (if locally indicated and available) unless contraindicated.
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) below or equal to 1
* Participants with adequate hematologic, hepatic and renal function as defined in protocol
* Other protocol defined inclusion criteria could apply

Criterios de exclusión

Criterios de exclusión:

* Participant has a history of malignancy within 3 years before the date of enrollment (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, benign prostate neoplasm/hypertropia, or malignancy that in the opinion of the Investigator, with concurrence with the Sponsor's Medical Monitor, is considered cured with minimal risk of recurrence within 3 years)
* Participants with known brain metastases, except those meeting the following criteria: Brain metastases that have been treated locally and are clinically stable for at least 4 weeks prior to the start of treatment; No ongoing neurological symptoms that are related to the brain localization of the disease (sequelae that are a consequence of the treatment of the brain metastases are acceptable)
* Participants with diarrhea (liquid stool) or ileus Grade > 1
* Participants with active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction
* Unstable angina, myocardial infarction, congestive heart failure (New York Heart Association [NYHA] >= II) or a coronary revascularization procedure within 180 days of study entry. Calculated QTc average (using the Fridericia correction calculation) of > 470 milliseconds (ms)
* Cerebrovascular accident/stroke (< 6 months prior to enrollment)
* Other protocol defined exclusion criteria could apply

NCT ID

NCT05464030

Fecha en que se añadió el juicio

2022-07-19

Fecha de actualización

2025-05-07