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NCT05464030Active, not recruitingPhase 1

Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)

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)

Source: ClinicalTrials.gov · Last updated 30 Jul 2026

Brief summary (registry, in English)

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

Status (registry)
Active, not recruiting
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
220 (actual)
First submitted
15 Jul 2022
Start date
4 Aug 2022
Primary completion date
23 Oct 2026
Lead sponsor
EMD Serono Research & Development Institute, Inc.
NCT number
NCT05464030
EU CT number
2022-500508-23-00

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 220
  • From 4 Aug 2022 to the primary completion date, 23 Oct 2026
  • 35 sites in 5 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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)
  • Cerebrovascular accident/stroke (\< 6 months prior to enrollment)

Other illness

  • 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 active chronic inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease, intestinal perforation) and/or bowel obstruction

Lab values

  • 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)

Other

  • Participants with diarrhea (liquid stool) or ileus Grade \> 1
  • Other protocol defined exclusion criteria could apply

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (35)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Ottawa Hospital Cancer Centre
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OttawaCanadaUnknown status
University Health Network - Princess Margaret Cancer Centre
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TorontoCanadaUnknown status
Hospital Clinic de Barcelona
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BarcelonaSpainUnknown status
Hospital HM Nou Delfos
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BarcelonaSpainUnknown status
Hospital Universitari Vall d'Hebron - VHIR
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BarcelonaSpainUnknown status
Hospital del Mar
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BarcelonaSpainUnknown status
Hospital Universitario Reina Sofia
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CórdobaSpainUnknown status
Ico L'Hospitalet - Hospital Duran I Reynals
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitario Fundación Jiménez Díaz
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MadridSpainUnknown status
Hospital Universitario Quironsalud Madrid - NEXT Oncology
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MadridSpainUnknown status
Centro Integral Oncologico Clara Campal
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Complejo Hospitalario Universitario de Santiago
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Santiago de CompostelaSpainUnknown status
Hospital Universitario Virgen del Rocio
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SevilleSpainUnknown status
National Cancer Center Hospital - Dept of Gastroenterology
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ChūōkuJapanUnknown status
National Cancer Center Hospital East
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Kashiwa-shiJapanUnknown status
Saitama Cancer Center
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Kitaadachi-gunJapanUnknown status
Cancer Institute Hospital of JFCR
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KōtokuJapanUnknown status
Aichi Cancer Center Hospital
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NagoyaJapanUnknown status
Kindai University Hospital
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Osakasayama-ShiJapanUnknown status
Shizuoka Cancer Center
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Sunto-gunJapanUnknown status
Kanagawa Cancer Center
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YokohamaJapanUnknown status
Kyungpook National University Chilgok Hospital
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DaeguSouth KoreaUnknown status
National Cancer Center
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Goyang-siSouth KoreaUnknown status
Seoul National University Bundang Hospital
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SeongnamSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Mary Crowley Cancer Research
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DallasUnited StatesUnknown status
California Cancer Associates for Research & Excellence, Inc.
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EncinitasUnited StatesUnknown status
California Cancer Associates for Research & Excellence, Inc.
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FresnoUnited StatesUnknown status
MD Anderson Cancer Center - Oncology
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HoustonUnited StatesUnknown status
Rhode Island Hospital
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ProvidenceUnited StatesUnknown status
NEXT Oncology
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San AntonioUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.