This study is a phase 1 open-label dose escalation study of the immuno-activating monoclonal antibody APX005M in adults with solid tumors. Study is intended to establish the maximum tolerated dose and the overall safety and tolerability of APX005M in 3 different administration schedules.
APX005M-001 is an open-label study and comprises a dose-escalation portion of approximately 8 dose level cohorts, plus an expansion cohort. Eligible subjects with solid tumors will receive intravenous APX005M every 3 week, every 2 week or every 1 week until disease progression, unacceptable toxicity or death, whichever occurs first. Study objectives include: * Evaluate safety of APX005M * Determine the maximum tolerated dose of APX005M * Determine the pharmacokinetic parameters of APX005M: the maximal drug concentration (Cmax), area under the curve of serum concentration over time (Area Under the Curve/ AUC), and half-life (t½). * Preliminary assessment of clinical response
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
43
APX005M is a CD40 agonistic monoclonal antibody
City of Hope
Duarte, California, United States
Case Western Reserve University
Cleveland, Ohio, United States
Abramson Cancer Center of The University of Pennsylvania
Philadelphia, Pennsylvania, United States
Incidence of dose limiting toxicities
The rate of DLTs will be assessed in approximately 56 subjects. DLTs will include Grade 4 neutropenia, anemia, thrombocytopenia, Grade 3or 4 nausea, cytokine release syndrome and other Grade 3 non-hematological toxicity
Time frame: Up to 28 days following first dose of APX005M
Incidence of adverse events
Incidence and severity of AEs and specific laboratory abnormalities graded according to NCI-CTCAE, v4.03
Time frame: Through up to approximately 4 weeks following last dose of APX005M
Blood concentrations of APX005M
PK parameters of APX005M
Time frame: Predose, 0.5, 1, 2, 4, 24, 48 and 168 hours following first and third dose of APX005M
Presence and titer of anti-APX005M antibodies
Assess incidence of anti-drug antibodies (ADA)
Time frame: Prior to first dose, approximately 3, 6 and 9 weeks following first dose and approximately 4 weeks following last dose of APX005M
Objective response rate according to Response Evaluation Criteria in Solid Tumors (RECIST)
Efficacy assessments will follow RECIST 1.1.
Time frame: Every 8 weeks up to approximately 1 year following first dose of APX005M
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.