At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 84 enrolled
Drug / intervention
GX-I7 +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating GX-I7, Pembrolizumab(KEYTRUDA®), and 1 other intervention for Triple Negative Breast Cancer. Completed, enrolled 84 participants across 12 sites.
Detailed 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
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTriple Negative Breast Cancer
CountriesSouth Korea
CollaboratorsMerck Sharp & Dohme LLC
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedNov 2018
Enrollment StartMar 2019
Primary CompletionMay 2023
TodayJul 2026
First PostedNov 26, 2018
Enrollment StartMar 27, 2019
Primary CompletionMay 11, 2023
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 7.6 years ago
Interventions
GX-I7drug
i.m.
Pembrolizumab(KEYTRUDA®)drug
i.v.
Cyclophosphamidedrug
i.v.