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

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

Study Overview

• Status: Completed
• Conditions: Triple Negative Breast Cancer
• Intervention / Treatment: Drug: GX-I7; Drug: Pembrolizumab(KEYTRUDA®); Drug: Cyclophosphamide

• Study Type: Interventional
• Enrollment (Actual): 84
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: combination with CPA, GX-I7, and pembrolizumab; Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab	Drug: GX-I7; i.m.; Other Names: Efineptakin alfa; Drug: Pembrolizumab(KEYTRUDA®); i.v.; Other Names: KEYTRUDA®; MK-3745; Drug: Cyclophosphamide; i.v.
Experimental: combination with GX-I7, and pembrolizumab; Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)	Drug: GX-I7; i.m.; Other Names: Efineptakin alfa; Drug: Pembrolizumab(KEYTRUDA®); i.v.; Other Names: KEYTRUDA®; MK-3745

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and nature of DLTs	To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab	during the first 5 weeks
Incidence, nature and severity of adverse events	graded according to NCI CTCAE v5.0	up to 24month
Objective response rate (ORR)	defined as percentage of subjects with a complete response (CR) or partial response (PR) per RECIST v.1.1	up to 24month

Collaborators and Investigators

• Sponsor: Genexine, Inc.
• Collaborators: Merck Sharp & Dohme LLC

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Actual): May 11, 2023
• Study Completion (Actual): May 11, 2023

Study Registration Dates

• First Submitted: November 19, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 26, 2018

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 1, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Breast cancer; TNBC
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Triple Negative Breast Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Immune Checkpoint Inhibitors; Cyclophosphamide; Pembrolizumab
• Other Study ID Numbers: GX-I7-CA-006; KEYNOTE-899 (Other Identifier: Merck Sharp & Dohme LLC); MK-3475-899 (Other Identifier: Merck Sharp & Dohme LLC)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• 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