A Phase I, Open-Label, Multicenter, Dose Escalation and Expansion Study of HM16390, as a Single Agent and in Combination with pembrolizumab, in Patients with Advanced or Metastatic Solid Tumors

Cancer Categories

Breast,Gastrointestinal (GI),Genitourinary (GU),Gynecologic,Head and Neck,Lung,Skin

Karmanos Trial ID

NCT ID

Age Group

Scope

Phase

Principal Investigator

Primary Objective:

To evaluate the safety and tolerability of HM16390 administered SC in subjects with advanced or metastatic solid tumors

Secondary Objectives:

To determine the MTD or recommended Phase II dose (RP2D) of HM16390 administered SC in subjects with advanced or metastatic solid tumors
To characterize the PK of HM16390 SC administration in subjects with advanced or metastatic solid tumors
To assess the anti-tumor effect of HM16390 SC administration in subjects with advanced or metastatic solid tumors

Eligibility

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.

Locations

4100 John R
Detroit, MI 48201
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Phone: 1-800-527-6266

31995 Northwestern Hwy
Farmington Hills, MI 48334
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Phone: 1-800-527-6266

Applicable Disease Site

Therapies, Drugs, Devices