The purpose of this study is to evaluate the safety and preliminary clinical activity of M9466 in combination with topoisomerase 1 inhibitors-based regimens. As such the combination with FOLFIRI (folinic acid, fluorouracil, irinotecan) and Bevacizumab will be evaluated in participants with colorectal cancer, to establish the M9466 maximum tolerated dose if observed and the recommended dose for expansion. Study Duration: After a Screening period of up to 28 days, enrolled participants will remain in the study until they have completed all the study visits or until they withdraw consent, are lost to follow-up, or die. Visit Frequency: The participants will come for a Screening Visit and 1 to 2 visits per treatment cycle. After end of study intervention period, the participants will come for an End of Treatment Visit and a Safety Follow-up Visit.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
3
M9466 will be administered orally until progressive disease, unacceptable toxicity, death, or end of study.
Irinotecan will be administered intravenously once every 2 weeks (q2w) until progressive disease, unacceptable toxicity, death, or end of study.
Folinic acid will be administered intravenously q2w as per standard of care.
Fluorouracil will be administered intravenously as per standard of care.
Bevacizumab will be administered intravenously, q2w until progressive disease, unacceptable toxicity, death, or end of study.
G-CSF will be administered subcutaneously at every cycle of study intervention as per standard of care.
Sarah Cannon Research Institute at Health One
Denver, Colorado, United States
Carolina BioOncology Institute, LLC - Cancer Therapy and Research Center
Pennington, New Jersey, United States
Vanderbilt University - 150912667
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Cancer Research SA
Elizabeth Vale, Australia
St George Private Hospital
Kogarah, Australia
Peter MacCallum Cancer Centre - Use the one with Account 2 VCCC
Parkville, Australia
National Cancer Center Hospital
Chūōku, Japan
Samsung Medical Center
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
...and 2 more locations
Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Treatment Related TEAEs
Time frame: Time from signing Informed Consent Form (ICF) up to 30 days after end of study intervention (approximately assessed up to 18.7 months)
Number of Participants with Dose Limiting Toxicity (DLT)
Time frame: Day 1 up to Day 28 of the first two Cycles (each cycle is of 14 days)
Pharmacokinetic (PK) Plasma Concentration of M9466
Time frame: Pre-dose up to 6 hours post-dose on Cycle 1 Day 1; (each cycle is of 14 days)
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) Assessed by Investigator
Time frame: Time from first treatment of study intervention up to planned assessment at 18.7 months
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