177Lu-J591 and 177Lu-PSMA-617 Combination for mCRPC
Status:
Terminated
Trial end date:
2020-07-15
Target enrollment:
Participant gender:
Summary
Phase I dose escalation study with combination of 177Lu-J591 and 177Lu-PSMA-617 using a
dose-fractionated regimen will be performed in patients with documented progressive
metastatic CRPC. The cumulative 177Lu-J591 dose for each subject will be 2.7 GBq/m2 (73
mCi/m2) of 177Lu with 20 mg J591 and the cumulative 177Lu-PSMA-617 dose for each subject will
vary (depending on the Cohort) from 3.7 GBq (100 mCi) to 18.5 GBq (500 mCi). The
177Lu-PSMA-617 dose will be escalated in up to 6 different dose levels (3+3 dose-escalation
study / de-escalation design). For the phase II portion, a minimum number of 14 patients will
be enrolled at MTD (including those enrolled at MTD in Phase I) and a maximum of 24.