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RECRUITING
NCT06959706
PHASE1

Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Participants With Advanced Solid Tumors

Sponsor: Tagworks Pharmaceuticals BV

View on ClinicalTrials.gov

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

Interventions

DRUG

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