The primary objective of the study is to evaluate the safety, tolerability, dose-limiting toxicity (DLT) and pharmacokinetics (PK) of acasunlimab (also known as GEN1046) administered as monotherapy or in combination with pembrolizumab in Japanese study participants with malignant solid tumors.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Acasunlimab will be administered intravenously (IV) once every 21 days.
Pembrolizumab will be administered IV once every 21 days.
National Cancer Center East
Chiba, Japan
National Cancer Center Hospital
Tokyo, Japan
Number of Participants with Dose limiting Toxicities (DLTs)
Determine the DLT profile of acasunlimab administered as monotherapy or in combination with pembrolizumab. The DLTs will be graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria version 5.0.
Time frame: During first cycle (Cycle length=21 days) in each cohort
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Time frame: From first dose date up to end of the safety follow up period, 90 days after last dose
Area under the concentration time curve (AUC) of Acasunlimab
Time frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)
Maximum (Peak) Plasma Concentration (Cmax) of Acasunlimab
Time frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)
Time to Reach Cmax (Tmax) of Acasunlimab
Time frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)
Plasma Trough (Pre-dose) Concentrations (Cthrough) of Acasunlimab
Time frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)
Elimination half-life (t 1/2) of Acasunlimab
Time frame: Predose and postdose at multiple timepoints of each cycle (Cycle length=21 days)
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Number of Participants with Anti-Drug Antibody (ADA) to Acasunlimab
Serum samples will be screened for ADAs to acasunlimab and the titer of confirmed positive samples will be reported.
Time frame: Up to 2 years