A Phase 1/2 Open-label Multicenter Study to Assess the Safety, Pharmacokinetics, and Anti-tumor Activity of GTAEXS617 in Patients With Advanced Solid Tumors
Summary
The primary purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and anti-tumor activity of GTAEXS617 (REC-617) in participants with advanced solid tumors.
Arms & interventions
- DrugGTAEXS617
Administered as specified in the treatment arm.
- DrugSoC
Participants will receive selected SoC regimen (fulvestrant, paclitaxel + bevacizumab, pegylated liposomal doxorubicin, or capecitabine) administered as specified in the treatment arm.
Outcome measures
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 2 years
Phase 1: Number of Participants With Dose Limiting Toxicities (DLTs)
Time frame: Up to 28 days
Phase 2 : Objective Response Rate (ORR) as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 2 years
Secondary
Phase 1: ORR as Assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
Time frame: Up to 2 years
Maximum Plasma Concentration (Cmax) of GTAEXS617
Time frame: Predose up to 24 hours postdose
Time Maximum Plasma Concentration (Tmax) of GTAEXS617
Time frame: Predose up to 24 hours postdose
Area under Plasma Concentration Curve From Time Zero to the Last Quantifiable Concentration (AUC0-inf) of GTAEXS617
Time frame: Predose up to 24 hours postdose
Duration of Response (DOR)
Time frame: Up to 2 years
Progression-Free Survival (PFS)
Time frame: Up to 2 years
Disease Control Rate (DCR)
Time frame: Up to 2 years
Eligibility criteria
Study locations (4)
USC Norris Comprehensive Cancer Center
Los Angeles, California, 90089
START Midwest
Grand Rapids, Michigan, 49546
START San Antonio
San Antonio, Texas, 78229
START Mountain Region
West Valley City, Utah, 84119