A dose escalation study to establish the safety profile and characterize the pharmacokinetic profile of IMC-CS4 in the treatment of subjects with advanced solid tumors refractory to standard therapy or for which no standard therapy is available.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
52
The Angeles Clinic & Research Institute
Los Angeles, California, United States
Univ of California San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Columbia University College of Phys & Surgeons
New York, New York, United States
Pharmacokinetics (PK) - Maximum Concentration (Cmax) of IMC-CS4
Pharmacokinetics (PK) - Maximum concentration (Cmax) of IMC-CS4.
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Minimum Concentration (Cmin) of IMC-CS4
Pharmacokinetics - Minimum concentration (Cmin) of IMC-CS4.
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4
Pharmacokinetics - Area Under the Curve (AUC) of IMC-CS4.
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics - Volume of Distribution at Steady State (Vss) of IMC-CS4
Pharmacokinetics - Volume of distribution at steady state (Vss) of IMC-CS4.
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Pharmacokinetics -Clearance (Cl) of IMC-CS4
Pharmacokinetics -Clearance (Cl) of IMC-CS4.
Time frame: Predose, 1, 2, 4 and 8 hours post dose of Cycle 1 Day 1, Cycle 1 Day 15, Cycle 1 Day 22 and Cycle 3 Day 1
Recommend Phase 2 Dose (RP2D) of IMC-CS4
The recommended Phase 2 dose was the highest dose where less than 1/3 of participants experienced dose limiting toxicities (DLTs). A DLT is defined as an adverse event (AE) occurring during Cycle 1 that fulfilled 1 of the following criteria: Any Common Terminology Criteria for Adverse Events (CTCAE), version (v) 4.0 Grade 4 neutropenia lasting ≥ 7 days, Grade 3 or 4 neutropenia complicated by fever ≥38.0°C or infection, Grade 4 thrombocytopenia, Grade 3 thrombocytopenia complicated by hemorrhage, Grade 3 or 4 anemia, Grade ≥3 AST/ALT elevation, Grade ≥2 AST/ALT elevation and Grade ≥2 bilirubin elevation and Grade 3 or 4 nonhematologic toxicity. A summary of other nonserious AEs and all Serious Adverse Events (SAE), regardless of causality is located in the Reported Adverse Event section.
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University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Time frame: Cycle 1 (6 Days)
Percentage of Participants With Anti-IMC-CS4 Antibody Assessment
The overall percentage of participants with treatment-emergent positive for anti-IMC-CS4 antibodies during the study. Participants were considered positive for anti-IMC-CS4 antibodies if they exhibited a post-treatment antibody level that exceeded the positive upper cut point determined from the normal anti-IMC-CS4 level seen in healthy untreated individuals.
Time frame: Up To 6 Months