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Recruiting Phase 1 NCT05464030

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

Phase 1 – testing safety in a small group of people
Conditions: Colorectal Cancer

Sponsor: EMD Serono Research & Development Institute, Inc.

trial.available_in: БГ
Overview
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
Who can participate
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
Interventions
M9140
DRUG
M9140
DRUG
Bevacizumab
DRUG
Capecitabine
DRUG
5-fluorouracil (5-FU)
DRUG
Folinic acid
DRUG
Locations 35
Canada (2)
The Ottawa Hospital Cancer Centre
Ottawa
University Health Network - Princess Margaret Cancer Centre
Toronto
Japan (8)
National Cancer Center Hospital - Dept of Gastroenterology
Chūōku
National Cancer Center Hospital East
Kashiwa-shi
Saitama Cancer Center
Kitaadachi-gun
Cancer Institute Hospital of JFCR
Kōtoku
Aichi Cancer Center Hospital
Nagoya
Kindai University Hospital
Osakasayama-shi
Shizuoka Cancer Center
Sunto-gun
Kanagawa Cancer Center
Yokohama
South Korea (7)
Kyungpook National University Chilgok Hospital
Daegu
National Cancer Center
Goyang-si
Seoul National University Bundang Hospital
Seongnam
Asan Medical Center
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Spain (12)
Hospital Clinic de Barcelona
Barcelona
Hospital del Mar
Barcelona
Hospital HM Nou Delfos
Barcelona
Hospital Universitari Vall d'Hebron - VHIR
Barcelona
Hospital Universitario Reina Sofia
Córdoba
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat
Centro Integral Oncologico Clara Campal
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Fundacion Jimenez Diaz
Madrid
Hospital Universitario Quironsalud Madrid - NEXT Oncology
Madrid
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital Universitario Virgen del Rocio
Seville
United States (6)
Mary Crowley Cancer Research
Dallas , Texas
California Cancer Associates for Research & Excellence, Inc.
Encinitas , California
COMPLETED
California Cancer Associates for Research & Excellence, Inc.
Fresno , California
COMPLETED
MD Anderson Cancer Center - Oncology
Houston , Texas
Rhode Island Hospital
Providence , Rhode Island
NEXT Oncology
San Antonio , Texas
Technical details
Status
Recruiting
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
04.08.2022
Completion date
23.10.2026
Registry ID
NCT05464030
Source
clinicaltrials.gov
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