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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Dose-escalation Cohort 1 | Experimental | The first level of dose of DM5167 |
|
| Part 1: Dose-escalation Cohort 2 | Experimental | The second level of dose of DM5167 |
|
| Part 1: Dose-escalation Cohort 3 | Experimental | The third level of dose of DM5167 |
|
| Part 1: Dose-escalation Cohort 4 | Experimental | The fourth level of dose of DM5167 |
|
| Part 1: Dose-escalation Cohort 5 | Experimental | The fifth level of dose of DM5167 |
|
| Part 1: Dose-escalation Cohort 6 | Experimental | The sixth level of dose of DM5167 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DM5167 | Drug | Once daily for 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Incidence of dose limiting toxicities (DLT) of DM5167 | Determined by National Cancer Institute (NCI) Common Terminology for Adverse Events (CTCAE) version 5.0 | 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 | First dose up to 28 days post end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under Curve (AUC) of DM5167 | AUC from the time of dosing to the time of the last measurable concentration | - 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) |
| Measure | Description | Time Frame |
|---|---|---|
| PARP inhibition in blood | Change in poly (ADP-ribose) (PAR) levels in peripheral blood mononuclear cells (PBMCs)) | Cycle 1, 2, 3, 5, 7 - Day 1: before the administration of DM5167 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MyungEun Jung | Contact | +82 31 757 220 | myungeun@digmbio.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Bundang Hospital | Recruiting | Gyeonggi-do | South Korea |
Individual participant data (IPD) will not be shared due to concerns regarding patient privacy, confidentiality, and compliance with applicable data protection regulations.
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| Part 2: Dose-expansion Cohort | Experimental | The recommended Phase 2 dose of DM5167 |
|
The proportion of subjects with best overall response (BOR) evaluated by RECIST version 1.1 |
| Through study completion, an average of 1 year |
| Maximum Concentration (Cmax) of DM5167 | Maximum observed concentration after administration | - 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 |
| Samsung Medical Center | Recruiting | Seoul | South Korea |
|
| Seoul National University Hospital | Recruiting | Seoul | South Korea |
|
| Severance Hospital | Recruiting | Seoul | South Korea |
|