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CompletedNCT03752723Updated Mar 5, 2024

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

A Phase 1/2 interventional study of GX-I7 and Pembrolizumab(KEYTRUDA®) in Triple Negative Breast Cancer, sponsored by Genexine, Inc.. Completed at 12 sites in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.

Sponsored by Genexine, Inc. · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
84
Allocation
Non-randomized
Ages
19 Years and older
Sex
Female
01

Study 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

02

Conditions studied

  • Triple Negative Breast Cancer

Keywords

  • Breast cancer
  • TNBC
03

Who can participate

Ages eligible
19 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
84 participants (actual)

Study arms

  • Experimental
    combination with CPA, GX-I7, and pembrolizumab

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

    Drug: GX-I7 · Drug: Pembrolizumab(KEYTRUDA®) · Drug: Cyclophosphamide

  • Experimental
    combination with GX-I7, and pembrolizumab

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

    Drug: GX-I7 · Drug: Pembrolizumab(KEYTRUDA®)

Interventions

  • DrugGX-I7

    i.m.

    Also known as: Efineptakin alfa

  • DrugPembrolizumab(KEYTRUDA®)

    i.v.

    Also known as: KEYTRUDA®, MK-3745

  • DrugCyclophosphamide

    i.v.

05

What researchers measure

Primary outcomes

  1. Incidence and nature of DLTs

    To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab

    Time frame: during the first 5 weeks

  2. Incidence, nature and severity of adverse events

    graded according to NCI CTCAE v5.0

    Time frame: up to 24month

  3. Objective response rate (ORR)

    defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1

    Time frame: up to 24month

06

Study locations

12 sites
  • Seoul National University Bundang Hospital
    Seongnam-si, Gyeonggi-do, Korea, Republic of
  • Ajou Medical Center
    Suwon-si, Gyeonggi-do, Korea, Republic of
  • National Cancer Center
    Goyang-si, Korea, Republic of
  • Gachon University Gil Medical Center
    Incheon, Korea, Republic of
  • Asan Medical Center
    Seoul, Korea, Republic of
  • Ewha Womans University Mokdong Hospital
    Seoul, Korea, Republic of
  • Gangnam Severance Hospital
    Seoul, Korea, Republic of
  • Korea University Anam Hospital
    Seoul, Korea, Republic of
  • Korea University Guro Hospital
    Seoul, Korea, Republic of
  • Samsung Medical Center
    Seoul, Korea, Republic of
  • Seoul ST.Mary's Hospital
    Seoul, Korea, Republic of
  • Severance Hospital
    Seoul, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03752723
Lead sponsor
Genexine, Inc.
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Nov 26, 2018
Start date
Mar 27, 2019
Primary completion
May 11, 2023
Completion
May 11, 2023
Last update
Mar 5, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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