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

NCT06806046 | Active Not Recruiting Phase 1

• 2 other identifiers: MS202329_0003CTR20244167
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Solid Tumors; Colorectal Cancer

Keywords

ADC; Anti-CEACAM5; colorectal cancer; solid tumors

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (1)

M9140

EXPERIMENTAL

Drug: M9140

Interventions

M9140 DRUG

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.

Also known as: Precemtabart tocentecan

M9140

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• Cerebrovascular accident/stroke (\< 6 months prior to enrollment)

Sponsors & Collaborators

• Merck KGaA, Darmstadt, Germany: collaborator
• Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany: lead

Study Sites (3)

Beijing Cancer Hospital

Beijing, China

Location

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, China

Location

Related Links

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

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Medical Responsible

  Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 3, 2025
• Study Start: December 20, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)