Phase I Study of HM16390 as a Single Agent and in Combination With Pembrolizumab in Advanced or Metastatic Solid Tumors

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

  • Advanced or Metastatic Solid Tumors

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