Anti-CEACAM5 ADC Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors

A Phase 1, Open-label Study of Anti-CEACAM5 Antibody-Drug Conjugate Precemtabart Tocentecan (M9140) in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)

The purpose of this study is to evaluate the safety and early clinical activity of M9140 in Chinese participants with locally advanced or metastatic colorectal cancer (CRC).

Study Overview

• Status: Active, not recruiting
• Conditions: Colorectal Cancer; Solid Tumors
• Intervention / Treatment: Drug: M9140

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Cancer hospital
  • Guangzhou, China
    • The Sixth Affiliated Hospital of Sun Yat-Sen University
  • Hangzhou, China
    • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants with documented histopathological diagnosis of locally advanced or metastatic CRC, who were intolerant/refractory to or progressed after standard systemic therapies for the advanced/metastatic stage that included and are restricted to a fluoropyrimidine, irinotecan, a platinum agent (e.g. oxaliplatin), an anti-EGFR agent (if clinically indicated, i.e. RAS/BRAF wt), and an anti-VEGF agent. Participants may have received previous treatment with trifluridine/tipiracil and/or regorafenib or fruquintinib, if locally indicated and available. Participants with a known 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
• Cerebrovascular accident/stroke (< 6 months prior to enrollment)
• Other protocol defined exclusion criteria could apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: M9140	Drug: M9140; M9140 will be administered every 3 weeks until progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study. There will be 2 dose levels, if the low dose level is tolerated, then M9140 will be escalated to the high dose level.; Other Names: Precemtabart tocentecan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Participants With Dose Limiting Toxicities (DLTs)	Up to 21 days (Each cycle is of 21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)	Up to 8 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetic (PK) Plasma Concentrations of M9140	Cycle 1 Day 1 (C1D1) - Predose, 6, 24, 168, 336 hr (hour) post dose: predose C2D1; C3D1 - Predose, 6, 24, 336 hr postdose; C4D1 - predose every 2 cycles until treatment discontinuation (20 months). [Each cycle is of 21 days]
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
Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator	Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
Progression-free Survival (PFS) According to RECIST v1.1	Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months

Collaborators and Investigators

• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
• Collaborators: Merck KGaA, Darmstadt, Germany
• Investigators: Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Publications and helpful links

Helpful Links

• Trial Awareness and Transparency website
• Related Info
• Medical Information Location Map - Med Info Contacts

Study record dates

Study Major Dates

• Study Start (Actual): December 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 29, 2025
• First Posted (Actual): February 3, 2025

Study Record Updates

• Last Update Posted (Actual): April 23, 2026
• Last Update Submitted That Met QC Criteria: April 22, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: colorectal cancer; solid tumors; ADC; Anti-CEACAM5
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: MS202329_0003; CTR20244167 (Registry Identifier: China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website http://bit.ly/IPD21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No