An Open-Label Phase I Safety, Pharmacokinetic & Dosimetry Study of 188Re-PTI-6D2 in Patients With Metastatic Melanoma
This study will evaluate the safety and feasibility of the administration of 188Re-PTI-6D2
in patients with metastatic melanoma. Patients with confirmed Stage IIIc (unresectable) or
Stage IV melanoma who meet all eligibility criteria will undergo a thorough physical
examination and baseline tumor imaging (whole body 18FDG PET/CT and MRI brain) to document
all sites of tumor.
Treatment will be administered on an inpatient basis. An initial cohort of 3 patients will
receive a tracer dose of 188Re-PTI-6D2 without any preceding unlabeled antibody. The tracer
dose will consist of 10 mCi of rhenium-labeled antibody; the amount of antibody (in mg) will
depend on specific activity and is estimated to range from 2 to 10 mg. Additional cohorts of
three patients each will receive 10 mg, 20 mg, and 50 mg of unlabeled PTI-6D2 immediately
preceding administration of the tracer dose. Patients will undergo serial gamma scans and
SPECT/CT imaging at specified time points. Blood samples will be obtained prior to dosing
and at specified intervals for PK measurements of the mAb as well as for measurement of
serum radioactivity. Urine will also be collected for all patients to measure excreted
radioactivity. Patients will be closely monitored for safety throughout the duration of the
Patients will remain at the study center for 48 hours after infusion to allow adequate time
for post-treatment safety observation, monoclonal antibody clearance and rhenium decay.
Prior to the escalation of the dose of unlabeled PTI-6D2, safety data from the inpatient
period and 2-week follow-up visit for the three patients at the current dose level will be
reviewed. If there is no evidence of a safety risk, the dose of unlabeled PTI-6D2 will be
escalated for the next cohort of patients. Dose escalation of unlabeled antibody will occur
according to a specific scheme.
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To select the amount of unlabeled PTI-6D2 to administer immediately prior to a tracer dose of 188Re-PTI-6D2 in order to achieve preferred tumor targeting
Eithan Galun, M.D.
Hadassah Hebrew University Hospital
Israel: Ministry of Health