DM5167 is a second-generation of PARP inhibitor that selectively targets the PARP-1 enzyme. This results in less haematological toxicity and a high level of safety. The aim of the study is to assess the safety and tolerability of DM5167 in patients with advanced solid tumors not respond to other treatments.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
58
Once daily for 28 days
Seoul National University Bundang Hospital
Gyeonggi-do, South Korea
RECRUITINGSamsung Medical Center
Seoul, South Korea
RECRUITINGSeoul National University Hospital
Seoul, South Korea
RECRUITINGPart 1: Incidence of dose limiting toxicities (DLT) of DM5167
Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0
Time frame: During the first cycle (28 days) of DM5167 treatment
Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs)
Clinically significant changes in vital signs, physical examination, ECG and clinical laboratory tests graded by NCI CTCAE v5.0
Time frame: First dose up to 28 days post end of treatment
Area Under Curve (AUC) of DM5167
AUC from the time of dosing to the time of the last measurable concentration
Time frame: - Cycle 1 - Day 1 & Day 15: pre-dose (0h) and up to 24 h post administration of DM5167 - Cycle 3, 5, 7 - Day 1: pre-dose
Objective response rate (ORR)
The proportion of subjects with best overall response (BOR) evaluated by RECIST version 1.1
Time frame: Through study completion, an average of 1 year
Maximum Concentration (Cmax) of DM5167
Maximum observed concentration after administration
Time frame: - Cycle 1 - Day 1 & Day 15: pre-dose (0h) and up to 24 h post administration of DM5167 - Cycle 3, 5, 7 - Day 1: pre-dose
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Severance Hospital
Seoul, South Korea
RECRUITING