Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors

Locally Advanced or Metastatic Solid Tumors Clinical Trial

Official title:

A Phase 1b, Open Label, Dose-escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03478995
• Other study ID #: GX-I7-CA-003
• Status: Completed
• Phase: Phase 1
• Start date: March 5, 2018
• Est. completion date: March 16, 2020

Study information

• Verified date: May 2020
• Source: Genexine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Patients will be enrolled in two stages:

• Dose-escalation stage: Approximately 15-30 patients will be enrolled.

• Dose-expansion stage: 6-12 patients will be enrolled. Dose-escalation slots will be filled first, then dose-expansion slots.

Description:

• Dose-escalation stage : designed as classical 3+3 to determine MTD or RP2D to evaluate approximately GX-I7.

• Dose-expansion stage : designed to enroll additional 6-12 patients to acquire additional safety and pharmacodynamic data to more fully inform the dose selection for RP2D

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Signed Informed Consent Form (ICF)

• Age = 19 years

• Able to comply with the study protocol, in the investigator's judgment

• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

• Life expectancy = 12 weeks

• Adequate hematologic and end organ function, defined by the following laboratory results obtained within 14 days prior to the first study treatment (Cycle 1, Day 1)

• Serum pregnancy test for women of childbearing potential (including women who have had a tubal ligation) must be performed and documented as negative within 14 days prior to Cycle 1, Day 1

• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and agreement to refrain from donating sperm

• Patients with histologic documentation of locally advanced, recurrent, or metastatic incurable solid tumors that has progressed after at least one available standard therapy; or for whom standard therapy has proven to be ineffective or intolerable, or is considered inappropriate

• Patients with measurable disease per RECIST v1.1

Exclusion Criteria:

• Inability to comply with study and follow-up procedures

• Pregnancy, lactation, or breastfeeding

• Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class II or greater), myocardial infarction within the previous 3 months, unstable arrhythmias, and/or unstable angina

• Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, and inherited liver disease or current alcohol abuse

• Poorly controlled Type 2 diabetes mellitus defined as a screening hemoglobin A1C = 8% or a fasting plasma glucose = 160 mg/dL (or 8.8 mmol/L)

• Major surgical procedure within 28 days prior to Cycle 1, Day 1, or anticipation of need for a major surgical procedure during the study

• Any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, and/or radiotherapy, within 3 weeks prior to initiation of study treatment

• Adverse events from prior anti-cancer therapy that have not resolved to Grade = 1 except for alopecia, vitiligo, or endocrinopathy managed with replacement therapy

• History of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, vasculitis, or glomerulonephritis

• Primary CNS malignancy, untreated CNS metastases, or active CNS metastases (progressing or requiring corticosteroids for symptomatic control)

• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins

Related Conditions & MeSH terms

• Locally Advanced or Metastatic Solid Tumors
• Neoplasms

Intervention

Drug:
• GX-I7
GX-I7 25mg/ml/vial

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Seoul St. Mary's Hospital, of the Catholic University	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Genexine, Inc.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT	Incidence of nature of DLTs	up to 24 months
Primary	AE	Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0	up to 24 months
Primary	ECG test evaluated by QTc	Change QTc from baseline (> 500 msec)	up to 24 months
Secondary	Pharmacokinetic (PK) profile	Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)	up to cycle 3 day 1(approximately 9 weeks)
Secondary	Anti-tumor activity	Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator	up to 24 months
Secondary	Immunogenicity	Incidence of anti-drug antibodies (ADAs) during the study	up to 24 months
Secondary	Exploratory Biomarker	Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment	up to 24 months