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Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Sponsor: EMD Serono Research & Development Institute, Inc.
Summary
The purpose of this first in-human study is to evaluate the safety, tolerability, pharmacokinetics, and preliminary clinical activity of M9140 in advanced solid tumors. This study contains 2 parts: Dose escalation (Part 1) and dose expansion (Part 2) Study details include: * Study Duration per participant: Approximately 4 months for Part 1 and 8 months for Part 2 * M9140 is not available through an expanded access program
Official title: A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2022-08-04
Completion Date
2027-02-26
Last Updated
2026-03-18
Healthy Volunteers
No
Conditions
Interventions
M9140
M9140 will be administered at an escalated dose until Maximum tolerated dose (MTD) and/or a safe recommended Dose for Expansion (RDE) is determined in Part 1 of the study.
M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
Bevacizumab
Bevacizumab will be administered intravenously as per standard of care.
Capecitabine
Capecitabine will be administered orally as per standard of care.
5-fluorouracil (5-FU)
5-FU will be administered intravenously as per standard of care.
Folinic acid
Folinic acid will be administered intravenously as per standard of care.
Locations (35)
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
California Cancer Associates for Research & Excellence, Inc.
Fresno, California, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Mary Crowley Cancer Research
Dallas, Texas, United States
MD Anderson Cancer Center - Oncology
Houston, Texas, United States
NEXT Oncology
San Antonio, Texas, United States
The Ottawa Hospital Cancer Centre
Ottawa, Canada
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
National Cancer Center Hospital - Dept of Gastroenterology
Chūōku, Japan
National Cancer Center Hospital East
Kashiwa-shi, Japan
Saitama Cancer Center
Kitaadachi-gun, Japan
Cancer Institute Hospital of JFCR
Kōtoku, Japan
Aichi Cancer Center Hospital
Nagoya, Japan
Kindai University Hospital
Osakasayama-shi, Japan
Shizuoka Cancer Center
Sunto-gun, Japan
Kanagawa Cancer Center
Yokohama, Japan
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Seoul National University Bundang Hospital
Seongnam, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital HM Nou Delfos
Barcelona, Spain
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Spain
Hospital Universitario Reina Sofia
Córdoba, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Centro Integral Oncologico Clara Campal
Madrid, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid, Spain
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain