Clinical trial NCT03733587: GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
Official title: A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumor
Lead sponsor: Genexine, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-07
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.

Detailed description: This is a Phase 1b study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.

This is 4 dose levels and increase dose level after confirm DLT of the previous dose.

Eligibility criteria: Inclusion Criteria:

* Histological confirmation of solid tumor, for which no standard therapy exists or is available any longer.
* Aged ≥19 years(Korean age).
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
* Life expectancy ≥12 weeks.
* Adequate hematological and end organ function defined by the following
* laboratory results obtained within 14 days prior to Cycle 1 Day 1 (C1D1)
* Female subjects of childbearing potential (including a female who has undergone tubal ligation) requires a negative serum pregnancy test performed within 14 days prior to C1D1.
* Have an evaluable lesion(s) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
* Subjects to be enrolled in the Phase 2a stage must be able to provide pre-treatment tissue biopsy or archival tissue and must have a tumor lesion.
* Providing the signed informed consent form (ICF).

Exclusion Criteria:

* Unable to adhere to the study procedures and follow-up procedures.
* Pregnant or lactating subjects.
* Have alcoholic or other hepatitis, liver cirrhosis, or genetic liver disease.
* Have uncontrolled type 2 diabetes mellitus.
* Have history of a major surgery within 28 days prior to C1D1 or are anticipated to require a major surgery during the study.
* Have an evidence of severe or uncontrolled systemic disease, uncontrolled hypertension.
* Have received any other investigational or approved anticancer therapy within 3 weeks prior to C1D1.
* With a positive result of human immunodeficiency virus (HIV) infection.

Primary outcomes:
measure: Incidence of DLT
timeFrame: within cycle 1(28days)
measure: Incidence and characteristics of AE
timeFrame: up to 24 months
measure: ORR
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence of ADAs
timeFrame: up to 24 months
measure: concentration of GX-I7
timeFrame: up to cycle 3 day 1(approximately 8 weeks)
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Genexine_clinical team
name: Minkyu Heo
role: STUDY_DIRECTOR
References: