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

PHASE1RecruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

August 4, 2022

Primary Completion Date

August 7, 2026

Study Completion Date

August 7, 2026

Conditions
Colorectal Cancer
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.

Trial Locations (35)

75230

RECRUITING

Mary Crowley Cancer Research, Dallas

77030

RECRUITING

MD Anderson Cancer Center - Oncology, Houston

78229

RECRUITING

NEXT Oncology, San Antonio

92024

COMPLETED

California Cancer Associates for Research & Excellence, Inc., Encinitas

93720

COMPLETED

California Cancer Associates for Research & Excellence, Inc., Fresno

02903

RECRUITING

Rhode Island Hospital, Providence

Unknown

RECRUITING

The Ottawa Hospital Cancer Centre, Ottawa

RECRUITING

University Health Network - Princess Margaret Cancer Centre, Toronto

RECRUITING

National Cancer Center Hospital - Dept of Gastroenterology, Chūōku

RECRUITING

National Cancer Center Hospital East, Kashiwa-shi

RECRUITING

Saitama Cancer Center, Kitaadachi-gun

RECRUITING

Cancer Institute Hospital of JFCR, Kōtoku

RECRUITING

Aichi Cancer Center Hospital, Nagoya

RECRUITING

Kindai University Hospital, Osakasayama-shi

RECRUITING

Shizuoka Cancer Center, Sunto-gun

RECRUITING

Kanagawa Cancer Center, Yokohama

RECRUITING

Kyungpook National University Chilgok Hospital, Daegu

RECRUITING

National Cancer Center, Goyang-si

RECRUITING

Seoul National University Bundang Hospital, Seongnam

RECRUITING

Asan Medical Center, Seoul

RECRUITING

Samsung Medical Center, Seoul

RECRUITING

Seoul National University Hospital, Seoul

RECRUITING

Severance Hospital, Yonsei University Health System, Seoul

RECRUITING

Hospital Clinic de Barcelona, Barcelona

RECRUITING

Hospital del Mar, Barcelona

RECRUITING

Hospital HM Nou Delfos, Barcelona

RECRUITING

Hospital Universitari Vall d'Hebron - VHIR, Barcelona

RECRUITING

Hospital Universitario Reina Sofia, Córdoba

RECRUITING

ICO l'Hospitalet - Hospital Duran i Reynals, L'Hospitalet de Llobregat

RECRUITING

Centro Integral Oncologico Clara Campal, Madrid

RECRUITING

Hospital Universitario 12 de Octubre, Madrid

RECRUITING

Hospital Universitario Fundacion Jimenez Diaz, Madrid

RECRUITING

Hospital Universitario Quironsalud Madrid - NEXT Oncology, Madrid

RECRUITING

Complejo Hospitalario Universitario de Santiago, Santiago de Compostela

RECRUITING

Hospital Universitario Virgen del Rocio, Seville

All Listed Sponsors
collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

lead

EMD Serono Research & Development Institute, Inc.

INDUSTRY

NCT05464030 - Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01) | Biotech Hunter | Biotech Hunter