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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
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).
M0324 will be further investigated in part 2 and part 3 of the study as combination regimen, in order to determine dose-toxicity relationship in combination and MTD (if reached) in order to support selection of RDE(s) in combination.
Pembrolizumab will be administered intravenously as per standard of care.
mFOLFIRINOX will be administered intravenously as per standard of care.
Yale University School of Medicine
New Haven, Connecticut, United States
NOT_YET_RECRUITINGIcahn School of Medicine at Mount Sinai
New York, New York, United States
NOT_YET_RECRUITINGNEXT Oncology
San Antonio, Texas, United States
RECRUITINGPrincess Margaret Cancer Centre
Toronto, Canada
NOT_YET_RECRUITINGNational Cancer Center Hospital
Chūōku, Japan
RECRUITINGParts 1 and 2: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 21
Part 1, 2 and 3: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Month 40
Part 3: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Day 1 up to Day 35
Parts 1 and 2: Pharmacokinetic (PK) Plasma Concentrations of M0324
Time frame: From Day 1 up to approximately 40 months
Parts 3: Pharmacokinetic (PK) Plasma Concentrations of M0324
Time frame: From Day 1 up to approximately 40 months
Percent Change from Baseline in Pharmacodynamic Markers
Pharmacodynamic and circulating biomarkers (e.g. cytokines) will be measured in blood.
Time frame: From Day 1 up to approximately 40 months
Objective Response (OR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) as Assessed by Investigator
Time frame: Time from first study treatment until progressive disease or death up to approximately 40 months
Progression-Free Survival (PFS) Time Per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
Time frame: Time from first study treatment until first documentation of progressive disease (PD) or death, assessed approximately up to 40 months
Duration of Response (DoR) According to RECIST v1.1 as Assessed by Investigator
Time frame: Time from first documentation of OR until progressive disease (PD) or death, assessed approximately up to 40 months
Part 3: Overall Survival (OS)
Time frame: Time from first study treatment until death, assessed approximately up to 40 months
Number of Participants With Positive Anti-Drug Antibody (ADA) of M0324
Time frame: Up to Month 40
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