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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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) - Adequate renal function. - Adequate hematologic function. - Adequate liver function.

Exclusion Criteria

  • 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. - Has ongoing or suspected autoimmune disease. - Known active and clinically significant bacterial, fungal or viral infection including known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness, immunocompromised patients. - History of chronic liver disease or evidence of hepatic cirrhosis.

Study Design

Phase
Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
1. Dose-Escalation Part: Divided into 2 arms (Arm A: HM16390 monotherapy, Arm B: HM16390 in combination with pembrolizumab) 2. Dose-Ranging Part: Subjects will be randomized 1:1 into at least two dose levels to enable better selection of the doses for further evaluation, and may apply to cohorts of both monotherapy and combination therapy 3. Dose-Expansion Part: Based on the available data from Dose-Escalation and Dose-Ranging parts, the most feasible dose will be selected as the RDE and will be administered to subjects in indication-specific expansion cohorts
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
HM16390 		HM16390 Monotherapy
  • Drug: HM16390
    HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle
  • Drug: pembrolizumab
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
    Other names:
    • KEYTRUDA®
Experimental
HM16390 + pembrolizumab 		HM16390 in combination with pembrolizumab
  • Drug: HM16390
    HM16390 will be administered subcutaneously using syringes on Day 1 of every 3-week treatment cycle
  • Drug: pembrolizumab
    Fixed dose of pembrolizumab will be administered as an IV infusion over 30 minutes on Day 1 of every 3-week treatment cycle
    Other names:
    • KEYTRUDA®

Recruiting Locations

Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114

More Details

Status
Recruiting
Sponsor
Hanmi Pharmaceutical Company Limited

Study Contact

Young Su (Bobby) Noh
82-2-410-9277
63forever@hanmi.co.kr

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.