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

NCT05464030 · tracked via the Priya Life Science USA tracker

Sponsor

EMD Serono Research & Development Institute, Inc.

Phase

Phase 1

Started

2022-08-04

Last updated

2026-07-30

Condition(s) studied

Colorectal Cancer

Investigational drug(s) / intervention(s)

M9140M9140BevacizumabCapecitabine5-fluorouracil (5-FU)Folinic acid

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.

M9140: M9140 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.

Bevacizumab: Bevacizumab will be administered intravenously as per standard of care.

Capecitabine: Capecitabine will be administered orally as per standard of care.

5-fluorouracil (5-FU): 5-FU will be administered intravenously as per standard of care.

Folinic acid: Folinic acid will be administered intravenously as per standard of care.

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion 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 Exclusion Criteria: * 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

Primary outcome measure(s)

Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) — up to 4 months
Part 1: Recommended Dose Expansion (RDE) of M9140 — up to 4 months
Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs) — up to 8 months
Part 2A: Number of Participants with Adverse Events (AEs) — up to 8 months
Part 2A: Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators — Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
Part 2A: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigators — Time from first study treatment to planned assessment at approximately 8 months

Trial sites (35)

Facility	City	Region
California Cancer Associates for Research & Excellence, Inc.	Encinitas	California
California Cancer Associates for Research & Excellence, Inc.	Fresno	California
Rhode Island Hospital	Providence	Rhode Island
Mary Crowley Cancer Research	Dallas	Texas
MD Anderson Cancer Center - Oncology	Houston	Texas
NEXT Oncology	San Antonio	Texas
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
Hospital HM Nou Delfos	Barcelona	Spain
Hospital Universitari Vall d'Hebron - VHIR	Barcelona	Spain
Hospital Universitario Reina Sofia	Córdoba	Spain
ICO l'Hospitalet - Hospital Duran i Reynals	L'Hospitalet de Llobregat	Spain
Centro Integral Oncologico Clara Campal	Madrid	Spain
Hospital Universitario 12 de Octubre	Madrid	Spain
Hospital Universitario Fundacion Jimenez Diaz	Madrid	Spain
Hospital Universitario Quironsalud Madrid - NEXT Oncology	Madrid	Spain
Complejo Hospitalario Universitario de Santiago	Santiago de Compostela	Spain
Hospital Universitario Virgen del Rocio	Seville	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05464030 on ClinicalTrials.gov ↗ ← All trials in the USA