Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
NCT ID: NCT05464030
Last Updated: 2025-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
200 participants
INTERVENTIONAL
2022-08-04
2026-08-07
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Part 1: M9140
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.
Part 2A: M9140
M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
Part 2B: M9140
M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
Part 2C: M9140 + Bevacizumab +/-Capecitabine
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.
Part 2D: M9140 + 5-fluorouracil + Folinic acid + Bevacizumab
M9140
M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
EMD Serono Research & Development Institute, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Responsible
Role: STUDY_DIRECTOR
EMD Serono Research & Development Institute, Inc.
Locations
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Aichi Cancer Center Hospital
Nagoya, , Japan
Kindai University Hospital
Osakasayama-shi, , Japan
Shizuoka Cancer Center
Sunto-gun, , Japan
Kanagawa Cancer Center
Yokohama, , Japan
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
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
Countries
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Central Contacts
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Facility Contacts
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References
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Kopetz S, Boni V, Kato K, Raghav KPS, Vieito M, Pallis A, Habermehl C, Siddiqui A, Courlet P, Sloot W, Raab-Westphal S, Hart F, Rodriguez-Rivera I. Precemtabart tocentecan, an anti-CEACAM5 antibody-drug conjugate, in metastatic colorectal cancer: a phase 1 trial. Nat Med. 2025 Oct;31(10):3504-3513. doi: 10.1038/s41591-025-03843-z. Epub 2025 Jul 30.
Related Links
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Trial Awareness and Transparency website
US Medical Information website, Medical Resources
Other Identifiers
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2022-500508-23-00
Identifier Type: OTHER
Identifier Source: secondary_id
MS202329_0001
Identifier Type: -
Identifier Source: org_study_id
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