M9140
DrugM9140 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.
Other names: Precemtabart tocentecan
NCT Number: NCT05464030
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
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
The Ottawa Hospital Cancer Centre, Ottawa, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Precemtabart tocentecan
Bevacizumab will be administered intravenously as per standard of care.
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.
Time frame: up to 4 months
Time frame: up to 4 months
Time frame: up to 8 months
Time frame: up to 8 months
Time frame: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 8 months
Time frame: Time from first study treatment to planned assessment at approximately 8 months
Time frame: Part 1: Pre-dose up to 4 months; Part 2: Pre-dose up to 8 months
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Time frame: Part 1: up to 4 months; Part 2: up to 8 months
Time frame: Part 1: baseline, up to 4 months; Part 2: baseline up to 8 months
Time frame: Time from first study treatment throughout the study duration until progressive disease or death up to approximately 4 months and 8 months
Time frame: Time from first study treatment to planned assessment at approximately 4 months and 8 months
Time frame: Time from first study treatment to planned assessment at approximately 8 months
Time frame: Time from first study treatment to planned assessment at approximately 4 months and 8 months
Time frame: Time from first study treatment to planned assessment at approximately 8 months
Time frame: up to 8 months
Time frame: At Week 12
EMD Serono Research & Development Institute, Inc.
Industry
A Phase I, Multicenter, Open-Label First in Human Study of Anti-CEACAM5 Antibody Drug Conjugate M9140 in Participants With Advanced Solid Tumors (PROCEADE-CRC-01)
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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