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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
230
START Midwest
Grand Rapids, Michigan, United States
RECRUITINGSTART San Antonio
San Antonio, Texas, United States
RECRUITINGSTART Mountain Region
West Valley City, Utah, United States
RECRUITINGGZA Ziekenhuizen - Campus Sint-Augustinus
Antwerp, Belgium
RECRUITINGClinique Universitaires Saint-Luc
Brussels, Belgium
RECRUITINGInstitute Jules Bordet
Brussels, Belgium
RECRUITINGCHU Sart Tilman
Liège, Belgium
RECRUITINGThe Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
RECRUITINGUCL Hospitals NHS Foundation Trust
London, United Kingdom
RECRUITINGThe Christie NHS Foundation Trust
Manchester, United Kingdom
RECRUITING...and 2 more locations
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
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
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