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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03752723
Recruitment Status : Active, not recruiting
First Posted : November 26, 2018
Last Update Posted : November 28, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Genexine, Inc.

Study Description
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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

Condition or disease Intervention/treatment Phase
Triple Negative Breast Cancer Drug: GX-I7 Drug: Pembrolizumab Drug: cyclophosphamide Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 83 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.

Drug: Pembrolizumab
i.v.

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.

Drug: Pembrolizumab
i.v.


Outcome Measures
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Primary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03752723


Locations
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Korea, Republic of
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
Sponsors and Collaborators
Genexine, Inc.
Merck Sharp & Dohme LLC
More Information
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Responsible Party: Genexine, Inc.
ClinicalTrials.gov Identifier: NCT03752723    
Other Study ID Numbers: GX-I7-CA-006
First Posted: November 26, 2018    Key Record Dates
Last Update Posted: November 28, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Keywords provided by Genexine, Inc.:
Breast cancer
TNBC
Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Pembrolizumab
Immunosuppressive Agents
 Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antineoplastic Agents, Immunological