NCT06806046

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)

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-12-20
• Primary completion: 2026-05-07
• Completion: 2026-05-07
• First posted: 2025-02-03
• Last updated: 2026-01-12

Locations

3 sites across 1 country: China