GX-I7 With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

Solid Tumor Clinical Trial

Official title:

A Phase 1b Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03733587
• Other study ID #: GX-I7-CA-005
• Status: Completed
• Phase: Phase 1
• Start date: October 17, 2018
• Est. completion date: May 13, 2020

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: May 13, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor

Intervention

Drug:
• GX-I7
GX-I7 25mg/ml/vial
• Cyclophosphamide
Cyclophosphamide 500mg/vial

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Seoul National University 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	Incidence of DLT	Incidence of nature of DLTs	within cycle 1(28days)
Primary	Incidence and characteristics of AE	Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03	up to 24 months
Primary	ORR	ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1	up to 6 months
Secondary	Incidence of ADAs	Incidence of anti-drug antibodies (ADAs) during the study	up to 24 months
Secondary	concentration of GX-I7	Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)	up to cycle 3 day 1(approximately 8 weeks)