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

NCT05464030 · EMD Serono
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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)
About this study
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 criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 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) * Other protocol defined exclusion criteria could apply
Study design
Enrollment target: 200 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2022-08-04
Estimated completion: 2027-02-26
Last updated: 2026-03-18
Interventions
Drug: M9140Drug: M9140Drug: BevacizumabDrug: CapecitabineDrug: 5-fluorouracil (5-FU)Drug: Folinic acid
Primary outcomes
  • Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (up to 4 months)
  • Part 1: Recommended Dose Expansion (RDE) of M9140 (up to 4 months)
  • Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) (up to 8 months)
Sponsor
EMD Serono Research & Development Institute, Inc. · industry
With: Merck KGaA, Darmstadt, Germany
Contacts & investigators
ContactUS Medical Information · contact · eMediUSA@emdserono.com · 888-275-7376
ContactCommunication Center · contact · service@emdgroup.com · +49 6151 72 5200
InvestigatorMedical Responsible · study_director, EMD Serono Research & Development Institute, Inc.
All locations (35)
California Cancer Associates for Research & Excellence, Inc.Completed
Encinitas, California, United States
California Cancer Associates for Research & Excellence, Inc.Completed
Fresno, California, United States
Rhode Island HospitalRecruiting
Providence, Rhode Island, United States
Mary Crowley Cancer ResearchRecruiting
Dallas, Texas, United States
MD Anderson Cancer Center - OncologyRecruiting
Houston, Texas, United States
NEXT OncologyRecruiting
San Antonio, Texas, United States
The Ottawa Hospital Cancer CentreRecruiting
Ottawa, Canada
University Health Network - Princess Margaret Cancer CentreRecruiting
Toronto, Canada
National Cancer Center Hospital - Dept of GastroenterologyRecruiting
Chūōku, Japan
National Cancer Center Hospital EastRecruiting
Kashiwa-shi, Japan
Saitama Cancer CenterRecruiting
Kitaadachi-gun, Japan
Cancer Institute Hospital of JFCRRecruiting
Kōtoku, Japan
Aichi Cancer Center HospitalRecruiting
Nagoya, Japan
Kindai University HospitalRecruiting
Osakasayama-shi, Japan
Shizuoka Cancer CenterRecruiting
Sunto-gun, Japan
Kanagawa Cancer CenterRecruiting
Yokohama, Japan
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Seoul National University Bundang HospitalRecruiting
Seongnam, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Hospital Clinic de BarcelonaRecruiting
Barcelona, Spain
Hospital del MarRecruiting
Barcelona, Spain
Hospital HM Nou DelfosRecruiting
Barcelona, Spain
Hospital Universitari Vall d'Hebron - VHIRRecruiting
Barcelona, Spain
Hospital Universitario Reina SofiaRecruiting
Córdoba, Spain
ICO l'Hospitalet - Hospital Duran i ReynalsRecruiting
L'Hospitalet de Llobregat, Spain
Centro Integral Oncologico Clara CampalRecruiting
Madrid, Spain
Hospital Universitario 12 de OctubreRecruiting
Madrid, Spain
Hospital Universitario Fundacion Jimenez DiazRecruiting
Madrid, Spain
Hospital Universitario Quironsalud Madrid - NEXT OncologyRecruiting
Madrid, Spain
Complejo Hospitalario Universitario de SantiagoRecruiting
Santiago de Compostela, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain
Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) · TrialPath