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Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

Primary Purpose

Triple Negative Breast Cancer

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
GX-I7
Pembrolizumab
cyclophosphamide
Sponsored by
Genexine, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Triple Negative Breast Cancer focused on measuring Breast cancer, TNBC

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Key Inclusion Criteria:

  1. Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) < 1% positive tumor nuclei, Progesterone Receptor (PR) < 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH).
  2. Subject must have received anthracycline and taxane based chemotherapy for TNBC
  3. Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology.
  4. Female subjects, age ≥ 19 years at the time of consent.

Key Exclusion Criteria:

  1. Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation.
  2. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.

Sites / Locations

  • Seoul National University Bundang Hospital
  • Ajou Medical Center
  • National Cancer Center
  • Gachon University Gil Medical Center
  • Asan Medical Center
  • Ewha Womans University Mokdong Hospital
  • Gangnam Severance Hospital
  • Korea University Anam Hospital
  • Korea University Guro Hospital
  • Samsung Medical Center
  • Seoul ST.Mary's Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

combination with CPA, GX-I7, and pembrolizumab

combination with GX-I7, and pembrolizumab

Arm Description

Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab

Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)

Outcomes

Primary Outcome Measures

Incidence and nature of DLTs
To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
Incidence, nature and severity of adverse events
graded according to NCI CTCAE v5.0
Objective response rate (ORR)
defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1

Secondary Outcome Measures

Full Information

First Posted
November 19, 2018
Last Updated
June 8, 2023
Sponsor
Genexine, Inc.
Collaborators
Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT03752723
Brief Title
Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)
Official Title
A Phase 1b/2, Open Label, Dose Escalation Study to Evaluate Safety, Tolerability, Pharmacodynamics and Antitumor Activity of GX-I7 in Combination With Pembrolizumab in Subjects With Refractory or Relapsed (R/R) TNBC
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
March 27, 2019 (Actual)
Primary Completion Date
May 11, 2023 (Actual)
Study Completion Date
May 11, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genexine, Inc.
Collaborators
Merck Sharp & Dohme LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the safety and tolerability of escalating doses GX-I7 in combination with standard dose pembrolizumab, and to evaluate objective response rate (ORR) in subjects with refractory or relapsed TNBC

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Triple Negative Breast Cancer
Keywords
Breast cancer, TNBC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
84 (Actual)

8. Arms, Groups, and Interventions

Arm Title
combination with CPA, GX-I7, and pembrolizumab
Arm Type
Experimental
Arm Description
Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab
Arm Title
combination with GX-I7, and pembrolizumab
Arm Type
Experimental
Arm Description
Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)
Intervention Type
Drug
Intervention Name(s)
GX-I7
Intervention Description
i.m.
Intervention Type
Drug
Intervention Name(s)
Pembrolizumab
Intervention Description
i.v.
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Description
i.v.
Primary Outcome Measure Information:
Title
Incidence and nature of DLTs
Description
To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab
Time Frame
during the first 5 weeks
Title
Incidence, nature and severity of adverse events
Description
graded according to NCI CTCAE v5.0
Time Frame
up to 24month
Title
Objective response rate (ORR)
Description
defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1
Time Frame
up to 24month

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Triple negative must be defined as guidelines of American Society of Clinical Oncology(ASCO)/ College of American Pathologist(CAP): Estrogen Receptor (ER) < 1% positive tumor nuclei, Progesterone Receptor (PR) < 1% positive tumor nuclei, and negative for HER2 by IHC 1+, 0 or negativity status confirmed by in situ hybridization (ISH). Subject must have received anthracycline and taxane based chemotherapy for TNBC Has measurable disease as defined by RECIST 1.1 as assessed by the the local site Investigator/radiology. Female subjects, age ≥ 19 years at the time of consent. Key Exclusion Criteria: Known severe hypersensitivity (≥ Grade 3) to pembrolizumab, pembrolizumab formulation excipients or GX-I7 formulation excipients or cyclophosphamide formulation. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (ie, CTLA-4, OX-40, CD137) or has previously participated in a Merck pembrolizumab (MK-3475) clinical trial.
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Ajou Medical Center
City
Suwon-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
National Cancer Center
City
Goyang-si
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Ewha Womans University Mokdong Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Seoul ST.Mary's Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Study of GX-I7 in Combination With Pembrolizumab in Refractory or Relapsed (R/R) TNBC Subjects(GX-I7-CA-006/KEYNOTE-899)

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