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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-G39 | Other Identifier | Merck & Sharp Dohme LLC | |
| MK-3475-G39 | Other Identifier | Merck & Sharp Dohme LLC |
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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This is a First-in-Human, Phase 1, Dose-Escalation and Dose-Expansion study of HM16390, as a single agent and in combination with pembrolizumab to assess safety, tolerability, MTD, RP2D, PK, and efficacy in patients with advanced or metastatic solid tumors.
Dose-Escalation Part is planned to establish the MTD or RDs for the randomized Dose-Ranging Part. Based on the results of the Dose-Escalation Part, additional eligible subjects will be randomized 1:1 into each dose level. After a comprehensive review of available data from both Dose-Escalation Part and Dose-Ranging Part, the RDEs to be tested in the Dose-Expansion Part are determined. Dose-Expansion Part is designed to assess the potential efficacy of HM16390 as a single agent and in combination with pembrolizumab when administered at the RDEs to subjects in indication-specific expansion cohorts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HM16390 | Experimental | HM16390 Monotherapy |
|
| HM16390 + pembrolizumab | Experimental | HM16390 in combination with pembrolizumab |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HM16390 | Drug | HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence and nature of DLTs | To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab | At the end of Cycle 1 (each cycle is 21 days) in Dose-Escalation Part |
| Incidence, nature, and severity of adverse events and laboratory abnormalities graded per NCI-CTCAE v5.0. | To evaluate safety and tolerability of HM16390 as a single agent, and in combination with pembrolizumab | Throughout the study until end of safety follow-up period (90 days after the last treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum serum concentration (Cmax) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The time to reach Cmax (Tmax) |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Young Su (Bobby) Noh | Contact | 82-2-410-9277 | 63forever@hanmi.co.kr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Recruiting | Boston | Massachusetts | 02114 | United States | |
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| pembrolizumab | Drug | Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle |
|
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To evaluate PK profile upon HM16390 administration
| Throughout the study until treatment discontinuation (up to 2-3 years) |
| The area under the concentration-time curve from time 0 to the last observable concentration (AUClast) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The AUC extrapolated to infinity (AUCinf) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The AUC during the dosing interval (AUCtau) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The serum concentration at the end of the dosing interval (Ctrough) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The elimination half-life (T1/2) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The apparent volume of distribution (Vd/F) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| The apparent clearance (CL/F) | To evaluate PK profile upon HM16390 administration | Throughout the study until treatment discontinuation (up to 2-3 years) |
| Objective response rate (ORR) | ORR will be measured as the proportion of subjects with a confirmed response of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 | Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) |
| Disease Control Rate (DCR) | DCR will be measured as the proportion of subject with confirmed CR, PR, or Stable Disease (SD) as per RECIST v1.1 | Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) |
| Progression-free survival (PFS) | PFS will be measured from date of first treatment until date of radiographic progression as per RECIST v1.1 or until death from any cause, whichever occurs first | Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) |
| Duration of response (DOR) | DOR will be measured as the time from initial onset of CR or PR to first radiographic progression as per RECIST v1.1 or death from any cause, whichever occurs first. | Throughout the study until disease progression or death whichever occurs first (up to 2-3 years) |
| Karmanos Cancer Institute |
| Not yet recruiting |
| Detroit |
| Michigan |
| 48201 |
| United States |
| Seoul National University Bundang Hospital | Recruiting | Seongnam-si | Gyeonggi-do | 13620 | South Korea |
| Seoul National University Hospital | Recruiting | Seoul | 03080 | South Korea |
| Severance Hospital | Recruiting | Seoul | 03722 | South Korea |
| Asan Medical Center | Active, not recruiting | Seoul | 05505 | South Korea |
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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