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

NCT05464030 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-05-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • EMD Serono Research & Development Institute, Inc.

    lead INDUSTRY

Principal Investigators

  • Medical Responsible · EMD Serono Research & Development Institute, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-04
Primary Completion
2026-10-23
Completion
2026-10-23
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Japan
  • South Korea
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05464030 on ClinicalTrials.gov