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

• ClinicalTrials.gov Identifier: NCT03752723
• Recruitment Status: Active, not recruiting
• First Posted: November 26, 2018
• Last Update Posted: November 28, 2022
• Sponsor: Genexine, Inc.
• Collaborator: Merck Sharp & Dohme LLC
• Information provided by (Responsible Party): Genexine, Inc.

Tracking Information

• First Submitted Date: November 19, 2018
• First Posted Date: November 26, 2018
• Last Update Posted Date: November 28, 2022
• Actual Study Start Date: March 27, 2019
• Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 21, 2018)

• 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
• Incidence, nature and severity of adverse events [ Time Frame: up to 24month ]
  graded according to NCI CTCAE v5.0
• 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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1; Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Triple Negative Breast Cancer

Intervention

• Drug: GX-I7
  i.m.
• Drug: Pembrolizumab
  i.v.
• Drug: cyclophosphamide
  i.v.

Study Arms

• Experimental: combination with CPA, GX-I7, and pembrolizumab

  Experimental: combination

  Assigned interventions: CPA, GX-I7 and pembrolizumab

  Interventions:

  • Drug: GX-I7
  • Drug: Pembrolizumab
  • Drug: cyclophosphamide
• Experimental: combination with GX-I7, and pembrolizumab

  Experimental: combination

  Assigned interventions: GX-I7 and pembrolizumab (without CPA)

  Interventions:

  • Drug: GX-I7
  • Drug: Pembrolizumab

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: March 30, 2020): 83
• Original Estimated Enrollment (submitted: November 21, 2018): 59
• Estimated Study Completion Date: April 2024
• Estimated Primary Completion Date: April 2023 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Female
• Gender Based Eligibility: Yes

• Ages: 19 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Korea, Republic of

Administrative Information

• NCT Number: NCT03752723
• Other Study ID Numbers: GX-I7-CA-006
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Current Responsible Party: Genexine, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genexine, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Merck Sharp & Dohme LLC
• Investigators: Not Provided
• PRS Account: Genexine, Inc.
• Verification Date: March 2022