NCT05464030

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: EMD Serono Research & Development Institute, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Colorectal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-04
• Primary completion: 2027-02-26
• Completion: 2027-02-26
• First posted: 2022-07-19
• Last updated: 2026-03-18

Locations

35 sites across 5 countries: United States, Canada, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study