At a glance
ClinicalIndex Comparison Record- ✓Histopathologically confirmed locally advanced or metastatic colorectal cancer
- ✓Intolerant, refractory to, or progressive disease after standard systemic therapies for advanced/metastatic stage
- ✓MSI-H patients must have received immune checkpoint inhibitor treatment if locally indicated and available, unless contraindicated
- ✓ECOG Performance Status ≤1
- ✕History of malignancy within 3 years before enrollment (with specified exceptions for skin cancers, cervical carcinoma in situ, benign prostate disease, or investigator-deemed cured malignancies)
- ✕Diarrhea (liquid stool) or ileus Grade >1
- ✕Active chronic inflammatory bowel disease or bowel obstruction
- ✕Unstable angina, myocardial infarction, congestive heart failure NYHA ≥II, or coronary revascularization within 180 days of study entry
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 1 clinical trial evaluating M9140, Bevacizumab, and 3 other interventions for Colorectal Cancer. Currently recruiting, targeting 200 participants across 35 sites in 5 countries.
Signals
Detailed 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
Study Details
Timeline
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.