Anti-CEACAM5 ADC M9140 in Advanced Solid Tumors (PROCEADE-CRC-01)
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)
EMD Serono Research & Development Institute, Inc.
200 participants
Aug 4, 2022
INTERVENTIONAL
Conditions
Summary
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
Eligibility
Plain Language Summary
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This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
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.
Locations(35)
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NCT05464030