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)
Status: Recruiting
Location: See all (35) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
California
California Cancer Associates for Research & Excellence, Inc.
COMPLETED
Encinitas
California Cancer Associates for Research & Excellence, Inc.
COMPLETED
Fresno
Rhode Island
Rhode Island Hospital
RECRUITING
Providence
Texas
Mary Crowley Cancer Research
RECRUITING
Dallas
MD Anderson Cancer Center - Oncology
RECRUITING
Houston
NEXT Oncology
RECRUITING
San Antonio
Other Locations
Canada
The Ottawa Hospital Cancer Centre
RECRUITING
Ottawa
University Health Network - Princess Margaret Cancer Centre
RECRUITING
Toronto
Japan
National Cancer Center Hospital - Dept of Gastroenterology
RECRUITING
Chūōku
National Cancer Center Hospital East
RECRUITING
Kashiwa-shi
Saitama Cancer Center
RECRUITING
Kitaadachi-gun
Cancer Institute Hospital of JFCR
RECRUITING
Kōtoku
Aichi Cancer Center Hospital
RECRUITING
Nagoya
Kindai University Hospital
RECRUITING
Osakasayama-shi
Shizuoka Cancer Center
RECRUITING
Sunto-gun
Kanagawa Cancer Center
RECRUITING
Yokohama
Republic of Korea
Kyungpook National University Chilgok Hospital
RECRUITING
Daegu
National Cancer Center
RECRUITING
Goyang-si
Seoul National University Bundang Hospital
RECRUITING
Seongnam
Asan Medical Center
RECRUITING
Seoul
Samsung Medical Center
RECRUITING
Seoul
Seoul National University Hospital
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
RECRUITING
Seoul
Spain
Hospital Clinic de Barcelona
RECRUITING
Barcelona
Hospital del Mar
RECRUITING
Barcelona
Hospital HM Nou Delfos
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron - VHIR
RECRUITING
Barcelona
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
ICO l'Hospitalet - Hospital Duran i Reynals
RECRUITING
L'hospitalet De Llobregat
Centro Integral Oncologico Clara Campal
RECRUITING
Madrid
Hospital Universitario 12 de Octubre
RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
RECRUITING
Madrid
Hospital Universitario Quironsalud Madrid - NEXT Oncology
RECRUITING
Madrid
Complejo Hospitalario Universitario de Santiago
RECRUITING
Santiago De Compostela
Hospital Universitario Virgen del Rocio
RECRUITING
Seville
Contact Information
Primary
US Medical Information
eMediUSA@emdserono.com
888-275-7376
Backup
Communication Center
service@emdgroup.com
+49 6151 72 5200
Time Frame
Start Date:2022-08-04
Estimated Completion Date:2026-08-07
Participants
Target number of participants:200
Treatments
Experimental: Part 1: M9140
Experimental: Part 2A: M9140
Experimental: Part 2B: M9140
Experimental: Part 2C: M9140 + Bevacizumab +/-Capecitabine