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OpenTrials
Completed

NCT Number: NCT03752723

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

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

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Key information

Conditions

Triple Negative Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms

Age range

19 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GX-I7

Drug

i.m.

Other names: Efineptakin alfa

Pembrolizumab(KEYTRUDA®)

Drug

i.v.

Other names: KEYTRUDA®, MK-3745

Cyclophosphamide

Drug

i.v.

Primary outcomes

  1. Incidence and nature of DLTs

    Time frame: during the first 5 weeks

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

  2. Incidence, nature and severity of adverse events

    Time frame: up to 24month

    graded according to NCI CTCAE v5.0

  3. Objective response rate (ORR)

    Time frame: up to 24month

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

Sponsors and collaborators

Lead sponsor

Genexine, Inc.

Industry

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Nov 26, 2018
Registry last updated
Mar 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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