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Brief Title Dose Escalation Study of TRX518 in Adults With Advanced Solid Tumors
Official Title A Two Part, Phase 1, Multicenter, Open-label Study of TRX518 in Adults With Advanced Solid Tumors - Part A: Dose-Escalation Part B: Expanded Cohort
Principal Investigator Luke, Jason
Brief Summary This study will be conducted in 2 parts (Part A and Part B). Subjects ≥18 years with advanced solid tumors will be enrolled in the study. Dose escalation will be performed in Part A. Cycle 1 data from each cohort will be evaluated for safety and dose-limiting toxicities (DLTs) prior to dose escalation. Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a patient is enrolled and cohorts will be dosed consecutively by ascending dose. Once the maximum tolerated dose (MTD) or maximum administered dose (MAD) has been identified, an expanded cohort will be enrolled (Part B).
Gender Both
Ages 18 Years
Enrollment 44
Accepts Healthy Volunteers No
Lead Sponsor GITR, Inc.Industry
Collaborator
Study Design Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Study Phase Phase 1
Study Type Interventional
Contact Name
Contact Phone 1-855-702-8222 (adult trials) or 1-773-702-6808 (pediatric trials)
Condition Solid Tumors
Detail for Health Professional (on clinicaltrials.gov)
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