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.
Have a histologically and/or cytologically confirmed advanced or metastatic solid tumor and have failed or are intolerant to standard therapy with clinical benefit.
Patients in the Dose-Escalation Part must have evaluable or measurable disease at baseline and the patients for Dose-Ranging and Dose-Expansion Part must have at least one measurable lesion at baseline by computed tomography (CT) or magnetic resonance imaging (MRI) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 assessed within 7 days before allocation or randomization.
Age of 18 years or older (or country's legal age of majority if the legal age was >18 years)
Received prior treatment with agent targeting the IL-2, IL-7, or IL-15 receptors, or related to mode of action of HM16390.
Known active CNS metastases and/or carcinomatous meningitis.
History of severe toxicities associated with a prior immunotherapy.
Any prior treatment-related (i.e. chemotherapy, immunotherapy, radiotherapy) clinically significant toxicities that have not resolved to Grade ≤ 1 per NCI-CTCAE version 5.0 or prior treatment-related toxicities that are clinically unstable and clinically significant at time of enrollment.
Parallel
HM16390
DrugHM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle
pembrolizumab
DrugFixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
Incidence and nature of DLTs
To evaluate safety and tolerability of HM16390 as a single agent and in combination with pembrolizumab
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
The maximum serum concentration (Cmax)
To evaluate PK profile upon HM16390 administration
The time to reach Cmax (Tmax)
To evaluate PK profile upon HM16390 administration
The area under the concentration-time curve from time 0 to the last observable concentration (AUClast)
To evaluate PK profile upon HM16390 administration
The AUC extrapolated to infinity (AUCinf)
To evaluate PK profile upon HM16390 administration
Click on the lead sponsor to view all of their trials.
Hanmi Pharmaceutical Company Limited
Lead sponsor
Merck Sharp & Dohme LLC
Collaborator
