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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
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 will be further investigated in part 2 of the study and includes dose optimization, an alternative administration regimen and combination regimen.
Bevacizumab will be administered intravenously as per standard of care.
Part 1: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Time frame: up to 4 months
Part 1: Recommended Dose Expansion (RDE) of M9140
Time frame: up to 4 months
Parts 2B, 2C and 2D: Number of Participants with Dose Limiting Toxicities (DLTs) and Adverse Events (AEs)
Time frame: up to 8 months
Part 2A: Number of Participants with Adverse Events (AEs)
Time frame: 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 frame: 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 frame: Time from first study treatment to planned assessment at approximately 8 months
Parts 1, 2A, 2B, 2C and 2D: Pharmacokinetic (PK) Plasma Concentrations of M9140
Time frame: Part 1: Pre-dose up to 4 months; Part 2: Pre-dose up to 8 months
Parts 1, 2A, 2B, 2C and 2D: Number of Participants with Anti-Drug Antibodies (ADA) Against M9140
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Parts 1, 2A, 2B, 2C and 2D: Levels of Titers of Anti-Drug Antibody (ADA) Against M9140
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Capecitabine will be administered orally as per standard of care.
5-FU will be administered intravenously as per standard of care.
Folinic acid will be administered intravenously as per standard of care.
California Cancer Associates for Research & Excellence, Inc.
Encinitas, California, United States
COMPLETEDCalifornia Cancer Associates for Research & Excellence, Inc.
Fresno, California, United States
COMPLETEDRhode Island Hospital
Providence, Rhode Island, United States
RECRUITINGMary Crowley Cancer Research
Dallas, Texas, United States
RECRUITINGMD Anderson Cancer Center - Oncology
Houston, Texas, United States
RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGThe Ottawa Hospital Cancer Centre
Ottawa, Canada
RECRUITINGUniversity Health Network - Princess Margaret Cancer Centre
Toronto, Canada
RECRUITINGNational Cancer Center Hospital - Dept of Gastroenterology
Chūōku, Japan
RECRUITINGNational Cancer Center Hospital East
Kashiwa-shi, Japan
RECRUITING...and 25 more locations
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Parts 1 and 2A: Number of Participants with Clinically Significant Changes from Baseline in Triplicate 12-Lead Electrocardiogram (ECG)
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Parts 1 and 2A: Change from Baseline in QTc (ΔQTc) Interval
Time frame: Part 1: baseline, up to 4 months; Part 2: baseline up to 8 months
Parts 1, 2B, 2C: and 2D: 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 4 months and 8 months
Parts 1, 2B, 2C and 2D: Duration of Response (DoR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time frame: Time from first study treatment to planned assessment at approximately 4 months and 8 months
Parts 2A, 2B, 2C and 2D: Time to Response
Time frame: Time from first study treatment to planned assessment at approximately 8 months
Parts 1, 2A, 2B, 2C and 2D: Progression-free Survival (PFS) 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 to planned assessment at approximately 4 months and 8 months
Part 2A: Overall Survival
Time frame: Time from first study treatment to planned assessment at approximately 8 months
Part 2A: Number of Participants with Symptomatic Adverse Events (AEs)
Time frame: up to 8 months
Parts 2A, 2B, 2C and 2D: Number of Participants with Disease Control
Time frame: At Week 12