GX-I7 With Cyclophosphamide in Patients With Metastatic o... | NCT03733587

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

NCT03733587

Sponsor

Genexine, Inc.

Status

Completed

Last Update Posted

May 14, 2020Actual

Enrollment

24Actual

Phase

Phase 1

Conditions

Solid Tumor

Interventions

GX-I7
Cyclophosphamide

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 17, 2018Actual

Primary Completion Date

Apr 2, 2020Actual

Completion Date

May 13, 2020Actual

First Submitted Date

Nov 5, 2018

First Submission Date that Met QC Criteria

Nov 5, 2018

First Posted Date

Nov 7, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 12, 2020

Last Update Posted Date

May 14, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cyclophosphamide and GX-I7	Experimental	Cyclophosphamide and determined dose of GX-I7 of each cycle	Drug: GX-I7 Drug: Cyclophosphamide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GX-I7	Drug	GX-I7 25mg/ml/vial	Cyclophosphamide and GX-I7
Cyclophosphamide

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Incidence of ADAs	Incidence of anti-drug antibodies (ADAs) during the study	up to 24 months
concentration of GX-I7	Serum concentration of GX-I7 at specified timepoints for the Area under the concentration time-curve (AUC)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam-si			South Korea
Seoul National University Hospital

ID	Term
C000712767	efineptakin alfa
D003520	Cyclophosphamide

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated