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

Description

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

Study Overview

Study Details

Study 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

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)

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

Condition
Colorectal Cancer
Intervention / Treatment

-

Contacts and Locations

Encinitas

California Cancer Associates for Research & Excellence, Inc., Encinitas, California, United States, 92024

Fresno

California Cancer Associates for Research & Excellence, Inc., Fresno, California, United States, 93720

Atlanta

Piedmont Cancer Institute, Atlanta, Georgia, United States, 30318

Providence

Rhode Island Hospital, Providence, Rhode Island, United States, 02903

Houston

MD Anderson Cancer Center - Oncology, Houston, Texas, United States, 77030

San Antonio

NEXT Oncology, San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

EMD Serono Research & Development Institute, Inc.,

Medical Responsible, STUDY_DIRECTOR, EMD Serono Research & Development Institute, Inc.

Study Record Dates

2026-02-27