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A Phase 1b/2a Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors

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ClinicalTrials.gov Identifier: NCT03733587
Recruitment Status : Recruiting
First Posted : November 7, 2018
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
Genexine, Inc.

Brief Summary:
This is a Phase 1b/2a study to explore the safety and efficacy of GX-I7 in combination with CPA in patients with metastatic or recurrent solid tumors.

Condition or disease Intervention/treatment Phase
Solid Tumor Drug: GX-I7 Drug: Cyclophosphamide Phase 1 Phase 2

Study Type : Interventional
Estimated Enrollment : 42 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b/2a Study of GX-I7 in Combination With Cyclophosphamide in Patients With Metastatic or Recurrent Solid Tumors
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : May 1, 2020
Estimated Study Completion Date : May 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cyclophosphamide and GX-I7
Cyclophosphamide and determined dose of GX-I7 of each cycle
Drug: GX-I7
GX-I7 25mg/ml/vial

Drug: Cyclophosphamide
Cyclophosphamide 500mg/vial
Other Name: Endoxan




Primary Outcome Measures :
  1. DLT on phase 1b [ Time Frame: within cycle 1(28days) ]
    Incidence of nature of DLTs

  2. AE on phase 1b [ Time Frame: up to 24 months ]
    Incidence, nature and severity of adverse events graded according to NCI CTCAEv4.03

  3. ORR for on phase 2a [ Time Frame: up to 6 months ]
    ORR defined as complete response (CR) or partial response (PR) per RECIST v1.1


Secondary Outcome Measures :
  1. Immunogenicity on phase 1b [ Time Frame: up to 24 months ]
    Incidence of anti-drug antibodies (ADAs) during the study

  2. Pharmacokinetic (PK) profile on phase 1b [ Time Frame: 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03733587


Contacts
Contact: Minkyu Heo +82 31 628 3340 mkheo@genexine.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Korea, Republic of
Contact: Keun-Wook Lee, MD    +82 31 787 7009    hmodoctor@hanmail.net   
Principal Investigator: Keun-Wook Lee, MD         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of
Contact: Yung-Jue Bang, MD    +82 2 2072 2390    bangyj@snu.ac.kr   
Principal Investigator: Yung-Jue Bang, MD         
Sponsors and Collaborators
Genexine, Inc.

Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT03733587     History of Changes
Other Study ID Numbers: GX-I7-CA-005
First Posted: November 7, 2018    Key Record Dates
Last Update Posted: November 7, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Cyclophosphamide
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists