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

Program Status

Recruiting

Phase

Phase 1

Prior Immunotherapy Allowed

Yes

CRC-directed Trial

Yes

Drugs

M9140

Tags

MSI-H/ MMRd, MSS/ MMRp

Comments

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.  

Location Location Status
United States
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California 92024
Recruiting
California Cancer Associates for Research & Excellence, Inc.
Fresno, California 93720
Recruiting
Rhode Island Hospital
Providence, Rhode Island 02903
Not yet recruiting
Mary Crowley Cancer Research
Dallas, Texas 75230
Recruiting
MD Anderson Cancer Center - Oncology
Houston, Texas 77030
Recruiting
NEXT Oncology
San Antonio, Texas 78229
Recruiting
Canada
The Ottawa Hospital Cancer Centre
Ottawa
Recruiting
University Health Network - Princess Margaret Cancer Centre
Toronto
Recruiting
Japan
National Cancer Center Hospital - Dept of Gastroenterology
Chuo-ku
Recruiting
National Cancer Center Hospital East
Kashiwa-shi
Recruiting
Saitama Cancer Center
Kitaadachi-gun
Recruiting
Cancer Institute Hospital of JFCR
Koto-ku
Recruiting
Aichi Cancer Center Hospital
Nagoya-shi
Recruiting
Kindai University Hospital
Osakasayama-shi
Recruiting
Shizuoka Cancer Center
Sunto-gun
Recruiting
Kanagawa Cancer Center
Yokohama-shi
Recruiting
Korea, Republic of
Kyungpook National University Chilgok Hospital
Daegu
Recruiting
National Cancer Center
Goyang-si
Recruiting
Seoul National University Bundang Hospital
Seongnam
Recruiting
Asan Medical Center
Seoul
Recruiting
Samsung Medical Center
Seoul
Recruiting
Seoul National University Hospital
Seoul
Recruiting
Severance Hospital, Yonsei University Health System
Seoul
Recruiting
Spain
Hospital Clinic de Barcelona
Barcelona
Recruiting
Hospital del Mar
Barcelona
Recruiting
Hospital HM Nou Delfos
Barcelona
Recruiting
Hospital Universitari Vall d'Hebron - VHIR
Barcelona
Recruiting
Hospital Universitario Reina Sofia
Cordoba
Recruiting
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat
Recruiting
Centro Integral Oncologico Clara Campal
Madrid
Recruiting
Hospital Universitario 12 de Octubre
Madrid
Recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Recruiting
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid
Recruiting
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Recruiting
Hospital Universitario Virgen del Rocio
Sevilla
Recruiting

Contacts

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

Inclusion Criteria

Inclusion Criteria:

* 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

Exclusion Criteria

Exclusion Criteria:

* 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

Date Trial Added

2022-07-19

Updated Date

2025-02-11