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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Triple Negative Breast Cancer

Intervention / Treatment
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* Drug: GX-I7
* Drug: Pembrolizumab
* Drug: cyclophosphamide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: combination with CPA, GX-I7, and pembrolizumab<br>Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab | Drug: GX-I7<br>* i.m.<br>Drug: Pembrolizumab<br>* i.v.<br>Drug: cyclophosphamide<br>* i.v.<br>|
| Experimental: combination with GX-I7, and pembrolizumab<br>Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA) | Drug: GX-I7<br>* i.m.<br>Drug: Pembrolizumab<br>* i.v.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast cancer, TNBC