Phase 1, First-in-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of TGW101 in Patients With Advanced Solid Tumors
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Written informed consent prior to any study procedures. 2. Males or females 18 years or older. 3. Histologically or cytologically confirmed diagnosis of a solid tumor malignancy listed below, with radiographic evidence of disease progression based on Response Evaluation Criteria in Solid Tumors (RECIST v1.1), or for castration resistant prostate cancer (CRPC), Prostate Cancer Clinical Trials Working Group 3, after most recent treatment and locally advanced or metastatic disease at Screening: 1. Breast cancer (all subtypes). 2. Castrate-resistant prostate cancer.…
Interventions
- DrugTGW101
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 (7)
- Honor HealthScottsdale, Arizona
- Massachusetts General HospitalBoston, Massachusetts
- Fox Chase Cancer CenterPhiladelphia, Pennsylvania
- University of Texas MD Anderson Cancer CenterHouston, Texas
- NEXT DallasIrving, Texas
- NEXT San AntonioSan Antonio, Texas