Clinical trial · Interventional
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
NCT03752723CI-TRIAL-00074680completedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| GX-I7 | Drug | — | UNRESOLVED |
| Pembrolizumab(KEYTRUDA®) | Drug | Pembrolizumab | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- combination with CPA, GX-I7, and pembrolizumab
- description
- Experimental: combination Assigned interventions: CPA, GX-I7 and pembrolizumab
- interventionNames
- Drug: GX-I7
- Drug: Pembrolizumab(KEYTRUDA®)
- Drug: Cyclophosphamide
- type
- EXPERIMENTAL
- label
- combination with GX-I7, and pembrolizumab
- description
- Experimental: combination Assigned interventions: GX-I7 and pembrolizumab (without CPA)
- interventionNames
- Drug: GX-I7
- Drug: Pembrolizumab(KEYTRUDA®)
Primary outcomes (3)
- measure
- Incidence and nature of DLTs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.