Trial of TRX518 (Anti-GITR mAb) in Stage III or IV Malignant Melanoma or Other Solid Tumors (TRX518-001)
TRX518-001 is an open label, non-randomized single group assignment, Phase 1 single dose escalation study in adults with biopsy proven unresectable Stage III or Stage IV melanoma or other solid tumor malignancies. The study objectives are to determine the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles of TRX518 and to define the maximum tolerated dose at which there are tolerable side effects and/or maximum PK/PD parameter changes.
Subjects will be assigned to a cohort in the order screening is completed. Dose will depend upon the cohort in which a subject is enrolled and cohorts will be dosed consecutively by ascending dose.
MSKCC Study #10-147
Unresectable Stage III or Stage IV Malignant Melanoma or Other Solid Tumor Malignancies
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- 1. Adverse events (Safety) [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]Any adverse change in health or side effect from the initiation of the study drug dose through completion or premature withdrawal.
- 2. Pharmacokinetics (PK) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Observations of the distribution, duration of effects and chemical changes of TRX518 in the body and the effects and routes of the body's elimination of TRX518.
- 3. Pharmacodynamics (PD) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]Observation of the effects of TRX518 on the body and immune system.
- Observation of effects, if any, on circulating lymphoid cell number and function, TRX518 potential immunogenicity, and TRX518 long term safety as reflected by adverse event reports at 6 - 24 months after a single dose. [ Time Frame: 6, 12, 18, 24 months ] [ Designated as safety issue: No ]
|Study Start Date:||October 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Humanized, Fc disabled, anti-human GITR (glucocorticoid-induced tumor necrosis factor receptor) monoclonal antibody
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.
|United States, New York|
|Melanoma and Sarcoma Service / Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Ruth-Ann Roman 646-888-2395 email@example.com|
|Principal Investigator: Jedd Wolchok, MD, PhD|
|United States, Ohio|
|Siedman Cancer Center / University Hospitals of Cleveland||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Henry Koon, MD 216-844-3951 firstname.lastname@example.org|
|Principal Investigator: Henry Koon, MD|
|Taussig Cancer Institute / Cleveland Clinic Foundation||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Pierre Triozzi, MD 216-445-5141 email@example.com|
|Principal Investigator: Pierre Triozzi, MD|
|Principal Investigator:||Principle Investigator: Jedd Wolchok, MD, PhD||Memorial Sloan-Kettering Cancer Center|