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

Running, not enrolling · Phase 1

Conditions studied: Colorectal Cancer

In brief

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

Key facts

Study ID

NCT05464030

Run by

EMD Serono Research & Development Institute, Inc.

People needed

220

Starts

2022-08-04

Expected to finish

2026-10-23

Last updated by the study team

2026-07-30

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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