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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
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.
Beijing Cancer Hospital
Beijing, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, China
Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 21 days (Each cycle is of 21 days)
Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to 8 months
Pharmacokinetic (PK) Plasma Concentrations of M9140
Time frame: 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 frame: 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 frame: 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 frame: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.