The purpose of this study is to evaluate the safety and tolerability of humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 (CM-24 \[MK-6018\]), administered intravenously as monotherapy and in combination with Pembrolizumab (MK-3475), in participants with selected advanced or recurrent malignancies. Escalating multiple doses will be evaluated to determine the recommended dose for Phase 2 clinical studies.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 by intravenous (IV) infusion
200 mg of Pembrolizumab by IV infusion
Call for Information (Investigational Site 0003)
Los Angeles, California, United States
Call for Information (Investigational Site 0004)
New Haven, Connecticut, United States
Merck Sharp & Dohme Co. Ltd.
Hod HaSharon, Israel
Number of participants with Adverse Events (AEs)
Time frame: From time of first dose until the end of follow-up (up to 123 weeks)
Number of participants discontinuing study drug due to AEs
Time frame: From time of first dose until the end of follow-up (up to 105 weeks)
Number of participants with a Dose Limiting Toxicity (DLT)
Time frame: From time of first dose until the end of follow-up (up to 12 weeks)
Maximum drug concentration in serum/plasma (Cmax)
Time frame: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.
Time to reach Cmax in serum/plasma (Tmax)
Time frame: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.
Terminal-phase elimination half-life in serum/plasma (t1/2)
Time frame: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.
Area under the plasma/serum concentration versus time curve from time zero to the last measured time (AUC 0-T)
Time frame: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.
Area under the plasma/serum concentration versus time curve from time zero to infinity (AUC 0-∞)
Time frame: For Cycles 1-35: all infusions at pre-infusion. For Cycle 1 first & fourth infusion: at end of infusion; 1, 4, 8 hours post-infusion; and Days 2, 3, 5, 8 post-infusion. For Cycle 1 fourth infusion also at Days 15, 22, 36 post-infusion.
Objective Response Rate (ORR) defined using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria
Time frame: From time of screening until the end of follow-up (up to 123 weeks)
Time from ORR to disease progression or death (DOR)
Time frame: From time of screening until the end of follow-up (up to 123 weeks)
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