Actively Recruiting
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Led by EMD Serono Research & Development Institute, Inc. · Updated on 2026-04-23
200
Participants Needed
35
Research Sites
220 weeks
Total Duration
On this page
Sponsors
E
EMD Serono Research & Development Institute, Inc.
Lead Sponsor
M
Merck KGaA, Darmstadt, Germany
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histopathological diagnosis of locally advanced or metastatic colorectal cancer
- Intolerance, refractory status, or progression after standard systemic therapies for advanced/metastatic colorectal cancer
- Known microsatellite instability-high (MSI-H) participants must have received immune checkpoint inhibitor treatment unless contraindicated
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
- Adequate hematologic, hepatic, and renal function as defined by the study protocol
- Other inclusion criteria as defined by the study protocol
You will not qualify if you...
- History of malignancy within 3 years before enrollment, except certain skin cancers, carcinoma in situ of the cervix, benign prostate conditions, or cancers considered cured with minimal recurrence risk
- Known brain metastases unless treated and stable for at least 4 weeks with no ongoing neurological symptoms related to brain disease
- Diarrhea (liquid stool) or ileus greater than Grade 1
- Active chronic inflammatory bowel disease or bowel obstruction
- Unstable angina, recent myocardial infarction, congestive heart failure (NYHA class II or higher), or coronary revascularization within 180 days before study entry
- QTc interval greater than 470 milliseconds
- Stroke within 6 months prior to enrollment
- Other exclusion criteria as defined by the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 35 locations
1
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States, 92024
Completed
2
California Cancer Associates for Research & Excellence, Inc.
Fresno, California, United States, 93720
Completed
3
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
4
Mary Crowley Cancer Research
Dallas, Texas, United States, 75230
Actively Recruiting
5
MD Anderson Cancer Center - Oncology
Houston, Texas, United States, 77030
Actively Recruiting
6
NEXT Oncology
San Antonio, Texas, United States, 78229
Actively Recruiting
7
The Ottawa Hospital Cancer Centre
Ottawa, Canada
Actively Recruiting
8
University Health Network - Princess Margaret Cancer Centre
Toronto, Canada
Actively Recruiting
9
National Cancer Center Hospital - Dept of Gastroenterology
Chūōku, Japan
Actively Recruiting
10
National Cancer Center Hospital East
Kashiwa-shi, Japan
Actively Recruiting
11
Saitama Cancer Center
Kitaadachi-gun, Japan
Actively Recruiting
12
Cancer Institute Hospital of JFCR
Kōtoku, Japan
Actively Recruiting
13
Aichi Cancer Center Hospital
Nagoya, Japan
Actively Recruiting
14
Kindai University Hospital
Osakasayama-shi, Japan
Actively Recruiting
15
Shizuoka Cancer Center
Sunto-gun, Japan
Actively Recruiting
16
Kanagawa Cancer Center
Yokohama, Japan
Actively Recruiting
17
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Actively Recruiting
18
National Cancer Center
Goyang-si, South Korea
Actively Recruiting
19
Seoul National University Bundang Hospital
Seongnam, South Korea
Actively Recruiting
20
Asan Medical Center
Seoul, South Korea
Actively Recruiting
21
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
22
Seoul National University Hospital
Seoul, South Korea
Actively Recruiting
23
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Actively Recruiting
24
Hospital Clinic de Barcelona
Barcelona, Spain
Actively Recruiting
25
Hospital del Mar
Barcelona, Spain
Actively Recruiting
26
Hospital HM Nou Delfos
Barcelona, Spain
Actively Recruiting
27
Hospital Universitari Vall d'Hebron - VHIR
Barcelona, Spain
Actively Recruiting
28
Hospital Universitario Reina Sofia
Córdoba, Spain
Actively Recruiting
29
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Actively Recruiting
30
Centro Integral Oncologico Clara Campal
Madrid, Spain
Actively Recruiting
31
Hospital Universitario 12 de Octubre
Madrid, Spain
Actively Recruiting
32
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Actively Recruiting
33
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid, Spain
Actively Recruiting
34
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela, Spain
Actively Recruiting
35
Hospital Universitario Virgen del Rocio
Seville, Spain
Actively Recruiting
Research Team
U
US Medical Information
CONTACT
C
Communication Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here