M0324
BiologicalM0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).
NCT Number: NCT07166601
The purpose of this first-in-human study is to identify a recommend dose(s) for subsequent larger studies (recommended dose(s) for expansion, RDE), examining increasing doses of M0324, primarily looking at safety, but also preliminary signs of efficacy, pharmacokinetics (PK), and pharmacodynamics (PD). Three different treatments with M0324 will be studied, M0324 as a monotherapy(Part 1), M0324 in combination with pembrolizumab (Part 2), and in combination with mFOLFIRINOX (a chemotherapy treatment)(Part 3).
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 1
Princess Margaret Cancer Centre, Toronto, Canada
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Part 1- M0324 Monotherapy:
Part 2- M0324 Combination with Pembrolizumab:
Part 3- M0324 Combination with mFOLFIRINOX:
Exclusion criteria
M0324 will be tested at increasing doses as monotherapy to determine dose-toxicity relationship and MTD (if reached) in order to support selection of recommended dose(s) for expansion (RDE).
Pembrolizumab will be administered intravenously as per standard of care.
mFOLFIRINOX will be administered intravenously as per standard of care.
Time frame: Day 1 up to Day 21
Time frame: Up to Month 40
Time frame: Day 1 up to Day 35
Time frame: From Day 1 up to approximately 40 months
Time frame: From Day 1 up to approximately 40 months
Time frame: From Day 1 up to approximately 40 months
Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.
Time frame: Time from first study treatment until progressive disease or death up to approximately 40 months
Time frame: Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months
Time frame: Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months
Time frame: Time from first study treatment until death, assessed approximately up to 40 months
Time frame: Up to Month 40
Contact information is provided by the study sponsor or research team.
Communication Center
CONTACT
US Medical Information
CONTACT
EMD Serono Research & Development Institute, Inc.
Industry
An Open Label, Multicenter, Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetic/Pharmacodynamic Profile of M0324, a Bispecific (MUC-1 x CD40) Antibody as Monotherapy, in Combination With Pembrolizumab, and in Combination With Chemotherapy, in Participants With Selected Advanced Solid Tumors
Acronym: TITER
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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