A Phase 1/2 Trial of TER-2013
Phase 1/2
205
about 3.4 years
18+
14 sites in FL, MA, MN +9
What this study is about
This trial is testing a treatment called TER-2013 in people with advanced solid tumors that have changes in the AKT/PI3K/PTEN pathway. The goal is to see if it's safe, well-tolerated, and effective at fighting cancer.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Receive Fulvestrant injection
- 2.Take TER-2013
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
fulvestrant
injection
Primary: Duration of Response as assessed by RECIST v1.1, Number of Patients who Experience Dose-Limiting Toxicity, Number of patients who experience a treatment-related adverse event, Objective Response Rate as assessed by RECIST v1.1
Secondary: Area under the plasma concentration-time curve for a dosing interval (AUCτ) of TER-2013, Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pAKT, Changes of pharmacodynamic markers of TER-2013 in tissue and/or blood as assessed by pPRAS40, Maximum concentration (Cmax) of TER-2013, Terminal elimination half-life (T1/2) of TER-2013, Time to maximum concentration (Tmax) of TER-2013
Oncology