Program Status
RecruitingPhase
Phase 1Prior Immunotherapy Allowed
YesCRC-directed Trial
YesDrugs
M9140Tags
MSI-H/ MMRd, MSS/ MMRpComments
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
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