A First-in-Human Single Ascending Dose Study of TRX518 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
The following visits are required:
- Screening visit: 1 to 2 appointments will be conducted to determine eligibility. All or
most requirements can be determined from the patient's medical records.
- Baseline visit: within 7 days of the planned study dosing day a baseline physical exam,
blood tests and electrocardiogram will be obtained.
- Dosing visit: 1 outpatient visit where TRX518 will be given IV over 1 hour followed by
4 hours of observation and some repeat blood tests.
- Follow up visits: 5 outpatient visits following dosing at 1, 8 and 15 days and 3, 6,
12, and 18 weeks post dosing
- Long term follow-up: 4 brief assessments by medical record review and/or telephone
contact at 6, 12, 18, and 24 months post dosing.
- The core study duration is 18 weeks. The follow-up study duration is 24 months.
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
1. Adverse events (Safety)
Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal.
Principle Investigator: Jedd Wolchok, MD, PhD
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
|Melanoma and Sarcoma Service / Memorial Sloan Kettering Cancer Center||New York, New York 10065|