Clinical Trials /

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

NCT03752723

Description:

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: GX-I7-CA-006
  • NCT ID: NCT03752723

Conditions

  • Triple Negative Breast Cancer

Interventions

DrugSynonymsArms
GX-I7pembrolizumab, cyclophosphamidecombination

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
combinationExperimentalExperimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab
  • GX-I7

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Incidence and nature of DLTs
Time Frame:during the first 5 weeks
Safety Issue:
Description:To evaluate the safety and tolerability of GX-I7 in combination with standard dose pembrolizumab

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Genexine, Inc.

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