Trials / Completed
CompletedNCT03752723
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
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 84 (actual)
- Sponsor
- Genexine, Inc. · Industry
- Sex
- Female
- Age
- 19 Years
- Healthy volunteers
- Not accepted
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GX-I7 | i.m. |
| DRUG | Pembrolizumab(KEYTRUDA®) | i.v. |
| DRUG | Cyclophosphamide | i.v. |
Timeline
- Start date
- 2019-03-27
- Primary completion
- 2023-05-11
- Completion
- 2023-05-11
- First posted
- 2018-11-26
- Last updated
- 2024-03-05
Locations
12 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03752723. Inclusion in this directory is not an endorsement.