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Triple Negative Breast CancerPhase 1/2NCT03752723

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 study testing GX-I7, Pembrolizumab(KEYTRUDA®) and Cyclophosphamide in people with Triple Negative Breast Cancer, run by Genexine, Inc. at 12 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 19 years and older, women only
Conditions the study is for
Triple Negative Breast Cancer
What is being tested?
GX-I7, Pembrolizumab(KEYTRUDA®) and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
12 sitesSouth Korea
Study dates
27 Mar 2019to 11 May 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

South Korea12 sites

  • National Cancer Center

    Goyang-si

  • Gachon University Gil Medical Center

    Incheon

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do

  • Asan Medical Center

    Seoul

  • Ewha Womans University Mokdong Hospital

    Seoul

  • Gangnam Severance Hospital

    Seoul

  • Korea University Anam Hospital

    Seoul

  • Korea University Guro Hospital

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul ST.Mary's Hospital

    Seoul

  • Severance Hospital

    Seoul

  • Ajou Medical Center

    Suwon, Gyeonggi-do

Other trials in South Korea

About this study

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

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

Being tested
GX-I7, Pembrolizumab(KEYTRUDA®), Cyclophosphamide
Keywords
Breast cancer, TNBC
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GX-I7Drug

    Also called Efineptakin alfa

    i.m.

  • Pembrolizumab(KEYTRUDA®)Drug

    Also called KEYTRUDA®, MK-3745

    i.v.

  • CyclophosphamideDrug

    i.v.

Study groups in NCT03752723
Study groupRoleWhat they receive
combination with CPA, GX-I7, and pembrolizumabExperimentalExperimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab
Receives: Drug: GX-I7; Drug: Pembrolizumab(KEYTRUDA®); Drug: Cyclophosphamide
combination with GX-I7, and pembrolizumabExperimentalExperimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)
Receives: Drug: GX-I7; Drug: Pembrolizumab(KEYTRUDA®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and nature of DLTs

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

    Measured: during the first 5 weeks

  2. Incidence, nature and severity of adverse events

    graded according to NCI CTCAE v5.0

    Measured: 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

    Measured: up to 24month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Nov 2018
  2. Study start27 Mar 2019
  3. Primary completion11 May 2023
  4. Study completion11 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03752723
Sponsor's protocol ID
GX-I7-CA-006
Other IDs
KEYNOTE-899, MK-3475-899
Status last verified
Feb 2024
First submitted
19 Nov 2018
Last updated
5 Mar 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GX-I7, Pembrolizumab(KEYTRUDA®) and Cyclophosphamide in people with Triple Negative Breast Cancer, run by Genexine, Inc. at 12 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and nature of DLTs (time frame: during the first 5 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03752723.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2024.

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