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

Phase 1

Completed

• Conditions: Solid Tumor
• Interventions: Drug: GX-I7; Drug: Cyclophosphamide

• Registration Number: NCT03733587
• Lead Sponsor: Genexine, Inc.

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.

Study Timeline

• Study Start: 2018-10-17
• Study First Submitted: 2018-11-05
• Study First Submitted QC: 2018-11-05
• Study First Posted: 2018-11-07
• Primary Completion: 2020-04-02
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-12
• Study Completion: 2020-05-13
• Last Update Posted: 2020-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Cyclophosphamide and GX-I7	Cyclophosphamide	Cyclophosphamide and determined dose of GX-I7 of each cycle
Cyclophosphamide and GX-I7	GX-I7	Cyclophosphamide and determined dose of GX-I7 of each cycle

Primary Outcome Measures

Name	Time	Method
Incidence of DLT	within cycle 1(28days)	Incidence of nature of DLTs
Incidence and characteristics of AE	up to 24 months	Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03
ORR	up to 6 months	ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1

Secondary Outcome Measures

Name	Time	Method
concentration of GX-I7	up to cycle 3 day 1(approximately 8 weeks)	Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)
Incidence of ADAs	up to 24 months	Incidence of anti-drug antibodies (ADAs) during the study

Trial Locations

Locations (2)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Korea, Republic of