study to evaluate safety and tolerability of gx-i7 in patients with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors

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.

* 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

Eligibility criteria:
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

Keywords: phase1b