Study to Evaluate Safety and Tolerability of GX-I7 in Patients With Locally Advanced or Metastatic Solid Tumors
- Registration Number
- NCT03478995
- Lead Sponsor
- Genexine, Inc.
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 35
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description GX-I7 GX-I7 Determined dose of GX-I7 on Day1 of each cycle
- Primary Outcome Measures
Name Time Method ECG test evaluated by QTc up to 24 months Change QTc from baseline (\> 500 msec)
DLT up to 24 months Incidence of nature of DLTs
AE up to 24 months Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.0
- Secondary Outcome Measures
Name Time Method Anti-tumor activity up to 24 months Objective response, defined as a complete response (CR) or partial response (PR) per RECIST v.1.1, as determined by the investigator
Immunogenicity up to 24 months Incidence of anti-drug antibodies (ADAs) during the study
Pharmacokinetic (PK) profile up to cycle 3 day 1(approximately 9 weeks) Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)
Exploratory Biomarker up to 24 months Changes in immune infiltrates, immune-related gene expression in tumor tissue prior to and during study treatment
Trial Locations
- Locations (3)
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
Severance Hospital
🇰🇷Seoul, Korea, Republic of
Seoul St. Mary's Hospital, of the Catholic University
🇰🇷Seoul, Korea, Republic of