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RECRUITING
NCT05464030
PHASE1

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

Sponsor: EMD Serono Research & Development Institute, Inc.

View on ClinicalTrials.gov

Summary

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

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2022-08-04

Completion Date

2027-02-26

Last Updated

2026-03-18

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

M9140

M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.

DRUG

Bevacizumab

Bevacizumab will be administered intravenously as per standard of care.

DRUG

Capecitabine

Capecitabine will be administered orally as per standard of care.

DRUG

5-fluorouracil (5-FU)

5-FU will be administered intravenously as per standard of care.

DRUG

Folinic acid

Folinic acid will be administered intravenously as per standard of care.

Locations (35)

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

Aichi Cancer Center Hospital

Nagoya, Japan

Kindai University Hospital

Osakasayama-shi, Japan

Shizuoka Cancer Center

Sunto-gun, Japan

Kanagawa Cancer Center

Yokohama, 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