This multicenter, open-label study will assess the safety and pharmacokinetics of DEDN6526A in patients with metastatic or unresectable melanoma. Cohorts of patients will receive escalating doses of DEDN6526A by intravenous infusion on Day 1 of each 21-day cycle. In the absence of disease progression or unacceptable toxicity, patients may continue to receive DEDN6552A for up to 17 cycles (1 year).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
53
Multiple ascending doses
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Sarasota, Florida, United States
Unnamed facility
Detroit, Michigan, United States
Unnamed facility
Nashville, Tennessee, United States
Safety: Incidence of adverse events
Time frame: assessed on an ongoing basis and up to 90 days following last dose of study treatment
Maximum tolerated dose/dose-limiting toxicities
Time frame: approximately one year after study start
Determination of recommended Phase II dose
Time frame: approximately 2 years
Pharmacokinetics: Area under the concentration-time curve
Time frame: Pre-dose, 30 min. and 4, 24, 48 hours post-dose and Days 7, 10, 15, 17 Cycles 1-4, pre-dose and 30 min. post-dose Cycle 5 and every other cycle thereafter
Anti-therapeutic antibody (ATA) levels
Time frame: Pre-dose Day 1 Cycles 1-4, and within 30 days post last dose
Tumor response (tumor assessments according to RECIST criteria)
Time frame: up to approximately 1 year
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Unnamed facility
Camperdown, New South Wales, Australia
Unnamed facility
East Melbourne, Victoria, Australia