Advanced Breast Cancer
Conditions
Brief summary
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.
Interventions
DRUGDM5167
Once daily for 28 days
Sponsors
DIGMBIO
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women aged 19 years or older as of the date of written informed consent * Patients who have at least one measurable lesion according to RECIST version 1.1 * ECOG performance status ≤ 1 * Patients with life expectancy ≥ 12 weeks * Patients who meet the clinical laboratory test criteria confirming adequate liver, renal, and hematologic function * Patients who voluntarily provide written informed consent to participate in this study * Patients with histologically or cytologically confirmed unresectable advanced solid tumors * Patients who have BRCA1/BRCA2 mutations
Exclusion criteria
* Patients with a medical history of significant illness * Patients with QT interval of \> 450 ms (for men) or \> 460 ms (for women)\\ * Patients who have not yet recovered from toxicity related to previous anticancer therapy * Patients were predicted to demonstrate hypersensitivity to the components of the investigational medicinal product * Patients who have participated in another clinical trial and received an investigational product or medical device * Other individuals deemed inappropriate for participation in the study by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Part 1: Incidence of dose limiting toxicities (DLT) of DM5167 | During the first cycle (28 days) of DM5167 treatment | Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0 |
| Part 1 and Part 2: Treatment emergent adverse events (TEAE) and serious adverse events (SAEs) | First dose up to 28 days post end of treatment | Clinically significant changes in vital signs, physical examination, ECG and clinical laboratory tests graded by NCI CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under Curve (AUC) of DM5167 | - 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 | AUC from the time of dosing to the time of the last measurable concentration |
| Objective response rate (ORR) | Through study completion, an average of 1 year | The proportion of subjects with best overall response (BOR) evaluated by RECIST version 1.1 |
| Maximum Concentration (Cmax) of DM5167 | - 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 | Maximum observed concentration after administration |
Other
| Measure | Time frame | Description |
|---|---|---|
| PARP inhibition in blood | Cycle 1, 2, 3, 5, 7 - Day 1: before the administration of DM5167 | Change in poly (ADP-ribose) (PAR) levels in peripheral blood mononuclear cells (PBMCs)) |
Countries
South Korea
Contacts
Primary ContactMyungEun Jung
Outcome results
None listed