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Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors
Sponsor: Tagworks Pharmaceuticals BV
Summary
The primary objectives of this study are to evaluate the safety and tolerability of TGW101 and determine the recommended dosing regimen(s) for further study. The secondary objectives are to assess pharmacokinetics and preliminary antitumor activity.
Official title: Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-05-07
Completion Date
2027-09
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
TGW101
TGW101 is a combination product comprising a chemically cleavable diabody drug conjugate (TGW101-ADC) and a corresponding small molecule chemical trigger (TRG001) administered separately.
Locations (6)
Honor Health
Scottsdale, Arizona, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
NEXT Dallas
Irving, Texas, United States
NEXT San Antonio
San Antonio, Texas, United States
NEXT Virginia
Fairfax, Virginia, United States