A study to evaluate the safety and anti-tumor activity of ASP3026 in patients with advanced malignancies (solid tumors).
This study will be conducted using a traditional 3 + 3 dose escalation study design. Enrollment of at least 3 subjects is planned for each dosing cohort. The decision to expand a cohort or dose escalate will be based on the occurrence of dose limiting toxicities (DLTs) in Cycle 1 that are considered by the Investigator to be related (possibly or probably) to ASP3026. The Safety Data Review Committee may elect to enroll additional subjects in a cohort to further evaluate the dose level. Each cycle will include 28 days of continuous dosing with ASP3026. Treatment with ASP3026 may continue until one of the discontinuation criteria is met. The maximum tolerated dose (MTD) is defined as the highest dose of ASP3026 on a dosing schedule at which \< 33% of subjects experience a DLT during Cycle 1. The MTD or lower dose, as determined by the Safety Data Review Committee, will be the recommended Phase 2 dose (RP2D). Twelve additional patients will be treated at the RP2D to further evaluate safety and tolerability.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
29
oral
Unnamed facility
Kansai, Japan
Safety and tolerability of ASP3026 assessed by recording of adverse events, laboratory assessments, vital signs, electrocardiograms (ECGs) and clinical observations
Time frame: Up to 30 days after last subject discontinues treatment
Pharmacokinetics of ASP3026 by assessment of area under the curve over the time (AUC) and maximum concentration (Cmax) in plasma and urine
Time frame: Up to Day 29
Objective response rate (ORR)
Objective response rate is the proportion of subjects who experience complete response/remission (CR) or partial response/remission (PR)
Time frame: 30 Days after the last subject discontinues treatment
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